<DOC>
[106th Congress House Hearings]
[From the U.S. Government Printing Office via GPO Access]
[DOCID: f:57443.wais]
Y2K AND MEDICAL DEVICES: SCREENING FOR THE Y2K BUG
=======================================================================
JOINT HEARING
before the
SUBCOMMITTEES ON
HEALTH AND ENVIRONMENT
and
OVERSIGHT AND INVESTIGATIONS
of the
COMMITTEE ON COMMERCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED SIXTH CONGRESS
FIRST SESSION
__________
MAY 25, 1999
__________
Serial No. 106-25
__________
Printed for the use of the Committee on Commerce
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COMMITTEE ON COMMERCE
TOM BLILEY, Virginia, Chairman
W.J. ``BILLY'' TAUZIN, Louisiana JOHN D. DINGELL, Michigan
MICHAEL G. OXLEY, Ohio HENRY A. WAXMAN, California
MICHAEL BILIRAKIS, Florida EDWARD J. MARKEY, Massachusetts
JOE BARTON, Texas RALPH M. HALL, Texas
FRED UPTON, Michigan RICK BOUCHER, Virginia
CLIFF STEARNS, Florida EDOLPHUS TOWNS, New York
PAUL E. GILLMOR, Ohio FRANK PALLONE, Jr., New Jersey
Vice Chairman SHERROD BROWN, Ohio
JAMES C. GREENWOOD, Pennsylvania BART GORDON, Tennessee
CHRISTOPHER COX, California PETER DEUTSCH, Florida
NATHAN DEAL, Georgia BOBBY L. RUSH, Illinois
STEVE LARGENT, Oklahoma ANNA G. ESHOO, California
RICHARD BURR, North Carolina RON KLINK, Pennsylvania
BRIAN P. BILBRAY, California BART STUPAK, Michigan
ED WHITFIELD, Kentucky ELIOT L. ENGEL, New York
GREG GANSKE, Iowa THOMAS C. SAWYER, Ohio
CHARLIE NORWOOD, Georgia ALBERT R. WYNN, Maryland
TOM A. COBURN, Oklahoma GENE GREEN, Texas
RICK LAZIO, New York KAREN McCARTHY, Missouri
BARBARA CUBIN, Wyoming TED STRICKLAND, Ohio
JAMES E. ROGAN, California DIANA DeGETTE, Colorado
JOHN SHIMKUS, Illinois THOMAS M. BARRETT, Wisconsin
HEATHER WILSON, New Mexico BILL LUTHER, Minnesota
JOHN B. SHADEGG, Arizona LOIS CAPPS, California
CHARLES W. ``CHIP'' PICKERING,
Mississippi
VITO FOSSELLA, New York
ROY BLUNT, Missouri
ED BRYANT, Tennessee
ROBERT L. EHRLICH, Jr., Maryland
James E. Derderian, Chief of Staff
James D. Barnette, General Counsel
Reid P.F. Stuntz, Minority Staff Director and Chief Counsel
______
Subcommittee on Health and Environment
MICHAEL BILIRAKIS, Florida, Chairman
FRED UPTON, Michigan SHERROD BROWN, Ohio
CLIFF STEARNS, Florida HENRY A. WAXMAN, California
JAMES C. GREENWOOD, Pennsylvania FRANK PALLONE, Jr., New Jersey
NATHAN DEAL, Georgia PETER DEUTSCH, Florida
RICHARD BURR, North Carolina BART STUPAK, Michigan
BRIAN P. BILBRAY, California GENE GREEN, Texas
ED WHITFIELD, Kentucky TED STRICKLAND, Ohio
GREG GANSKE, Iowa DIANA DeGETTE, Colorado
CHARLIE NORWOOD, Georgia THOMAS M. BARRETT, Wisconsin
TOM A. COBURN, Oklahoma LOIS CAPPS, California
Vice Chairman RALPH M. HALL, Texas
RICK LAZIO, New York EDOLPHUS TOWNS, New York
BARBARA CUBIN, Wyoming ANNA G. ESHOO, California
JOHN B. SHADEGG, Arizona JOHN D. DINGELL, Michigan,
CHARLES W. ``CHIP'' PICKERING, (Ex Officio)
Mississippi
ED BRYANT, Tennessee
TOM BLILEY, Virginia,
(Ex Officio)
(ii)
Subcommittee on Oversight and Investigations
FRED UPTON, Michigan, Chairman
JOE BARTON, Texas RON KLINK, Pennsylvania
CHRISTOPHER COX, California HENRY A. WAXMAN, California
RICHARD BURR, North Carolina BART STUPAK, Michigan
Vice Chairman GENE GREEN, Texas
BRIAN P. BILBRAY, California KAREN McCARTHY, Missouri
ED WHITFIELD, Kentucky TED STRICKLAND, Ohio
GREG GANSKE, Iowa DIANA DeGETTE, Colorado
ROY BLUNT, Missouri JOHN D. DINGELL, Michigan,
ED BRYANT, Tennessee (Ex Officio)
TOM BLILEY, Virginia,
(Ex Officio)
(iii)
C O N T E N T S
__________
Page
Testimony of:
Hubbard, William K., Acting Deputy Commissioner for Policy,
accompanied by Thomas Shope, Special Assistant to the
Director, Office of Science and Technology Center for
Devices and Radiological Health, Food and Drug
Administration............................................. 13
Nunn, John C., Vice President for Patient Care Services,
Henry Ford Hospital, on behalf of the American Hospital
Association................................................ 63
Smith, Kent T., Global Project Manager, Baxter Healthcare
Corporation, on behalf of the Health Industry Manufacturers
Association................................................ 52
Willemssen, Joel C., Director, Civil Agencies Information
Systems Accounting and Information Management Division,
General Accounting Office.................................. 20
Williams, Noel Brown, Senior Vice President, Columbia HCA
Health Care Corporation, on behalf of the Federation of
American Health Systems; accompanied by Don Workman,
Columbia HCA Health Care Corporation....................... 59
(v)
Y2K AND MEDICAL DEVICES: SCREENING FOR THE Y2K BUG
----------
TUESDAY, MAY 25, 1999
House of Representatives,
Committee on Commerce,
Subcommittee on Health and Environment,
and the Subcommittee on Oversight and Investigations,
Washington, DC.
The subcommittees met, pursuant to notice, at 10:10 a.m.,
in room 2123, Rayburn House Office Building, Hon. Michael
Bilirakis (chairman, Subcommittee on Health and the
Environment) and Hon. Fred Upton (chairman, Subcommittee on
Oversight and Investigations) presiding.
Members present Subcommittee on Health and Environment:
Representatives Bilirakis, Upton, Sterans, Burr, Bilbray,
Ganske, Bryant, Bliley (ex officio), and Brown.
Members present Subcommittee on Oversight and
Investigations: Representatives Upton, Burr, Bilbray, Ganske,
Blunt, Bryant, Bliley (ex officio), Klink, and McCarthy.
Staff present: Lori Wall, majority counsel; John Manthei,
majority counsel; Michael Flood, legislative clerk; Chris
Knauer, minority professional staff member, and John Ford,
minority counsel.
Mr. Bilirakis. The hearing will come to order. Good
morning.
I am pleased that our two subcommittees, the Health and
Environment Subcommittee and the Oversight and Investigations
Subcommittee under Mr. Upton, have convened today to ensure, or
at least to try to help to ensure, that healthcare delivery is
not interrupted by the Y2K computer problem.
Specifically, we want to guarantee that medical devices
using computer software will function properly after the 1st of
January of the year 2000. Any failure, by any device, caused by
the Y2K problem is one failure too many; I am sure we all agree
with that. There is no room for error because human lives are
at risk.
Today, we will hear what steps have been taken by the Food
and Drug Administration, the medical device industry, and
individual hospitals on medical device Y2K compliance.
Medical devices play a critical role in the daily delivery
of healthcare, and can range from basic thermometers to more
complex devices such as electrocardiograms and infusion pumps.
Certainly, if devices that utilize computer software fail to
operate, or give improper readings, patients all over the
country, and indeed the world, may be put at an unnecessary
risk.
The FDA has testified before Congress on this subject over
the last couple of years. Unfortunately, in some instances, the
FDA has not had positive news to report. Today, I look forward
to hearing the progress that the agency has made toward
addressing this very pressing health concern.
The General Accounting Office will offer additional
testimony on the FDA's efforts. In particular, the GAO will
provide Congress with recommendations on its thorough audit of
FDA's activities and the Y2K problem.
With respect to our second panel, we will hear about the
steps individual hospitals and medical device manufacturers are
taking to address the unique challenges resulting from the Y2K
problem. Only the medical device manufacturers have complete
access to a device's design, operating details, and
manufacturing parameters. Therefore, their testimony is
particularly important.
We look forward to hearing about the steps that the
industry is taking to guarantee the safety of patients. With
respect to the hospital industry witnesses, we are interested
in specific examples of initiatives being undertaken to provide
hospitals with the most up-to-date information and products.
On behalf of Mr. Upton and myself, I would like to welcome
all of our witnesses and thank them for taking time out of
their very busy schedules to join us this morning, and we all
look forward to hearing your testimony. Mr. Bliley, the
chairman of the full committee, for an opening statement.
[The prepared statement of Hon. Michael Bilirakis follows:]
Prepared Statement of Hon. Michael Bilirakis, Chairman, Subcommittee on
Health and Environment
Mr. Chairman, I am pleased that we have convened our two
Subcommittees today to ensure that health care delivery is not
interrupted by the Y2K computer problem.
Specifically, we want to guarantee that medical devices using
computer software will function properly after January 1, 2000. Any
failure, by any device, caused by the Y2K problem, is one failure too
many. There is no room for error because human lives are at risk.
Today, we will hear what steps have been taken by the Food and Drug
Administration, the medical device industry, and individual hospitals
on medical device Y2K compliance.
Medical devices play a critical role in the daily delivery of
health care, and, can range from basic thermometers to more complex
devices such as electrocardiograms and infusion pumps. Certainly, if
devices that utilize computer software fail to operate, or give
improper readings, patients all over the country, and indeed the world,
may be put at an unnecessary risk.
The FDA has testified before Congress on this subject over the last
couple of years--unfortunately, in some instances, the FDA has not had
positive news to report. Today, I look forward to hearing the progress
the Agency has made toward addressing this pressing health concern. The
General Accounting Office will offer additional testimony on the FDA's
efforts. In particular, the GAO will provide Congress with
recommendations on its thorough audit of FDA's activities on the Y2K
problem.
With respect to our second panel, we will hear about the steps
individual hospitals and medical device manufacturers are taking to
address the unique challenges resulting from the Y2K problem. Only the
medical device manufacturers have complete access to a device's design,
operating details, and manufacturing parameters, therefore, their
testimony is particularly important.
I look forward to hearing about the steps that the industry has
taken to guarantee the safety of patients. With respect to the hospital
industry witnesses, I am interested in specific examples of initiatives
being undertaken to provide hospitals with the most up to date
information on products.
Finally, I want to welcome all of our witnesses and thank them for
taking time out of their busy schedules to join us this morning. I look
forward to hearing your testimony.
Chairman Bliley. Thank you, Mr. Chairman.
Several months ago, this committee began an in-depth look
at the healthcare industry and its efforts to become ready for
the year 2000. Letters were sent to the Health Care Financing
Administration and healthcare associations representing
Medicare contractors and Medicare providers, asking them about
their progress in becoming year 2000 ready, or Y2K compliant.
Over the past year, this committee has received regular
updates on the progress of the Department of Health and Human
Services and what progress they have made in addressing their
Y2K problems. Just last month, this committee held a hearing on
the Y2K problem as it relates to billing and financial systems.
However, the issue of Y2K readiness includes not only
billing and financial services, but also products associated
with healthcare delivery, such as medical devices.
Today, we will hear about how medical devices and
biomedical equipment are in terms of Y2K readiness. Medical
devices are critical to medical treatment and research in both
Federal as well as private sector healthcare facilities. Any
equipment that performs a date or time calculation is
potentially susceptible to the Y2K bug.
Since 1997, the Food and Drug Administration of FDA, as
well as the Veterans' Health Administration, and others, have
attempted to collect information from manufacturers of medical
equipment regarding any Y2K problem a device or piece of
equipment may have. A data base clearinghouse was established
that would allow providers to find out whether a particular
piece of equipment was Y2K compliant.
Since this process began over 2 years ago, progress has
been made. Unfortunately, there are still device manufacturers
who have not responded to repeated requests from the FDA to
provide information on the Y2K status of their equipment.
Therefore, Medicare providers are often left wondering whether
or not their equipment will be safe as we enter the new year.
I hope this hearing will allow us to gain a better insight
into the process that medical device manufacturers, Medicare
providers, and FDA have undertaken in order to ensure that
medical devices and equipment will be Y2K compliant. The health
and safety of Medicare patients is of the utmost importance.
I would like to welcome all our panelists here today and
thank you all for coming and testifying before us. Mr.
Chairman, thank you.
Mr. Bilirakis. Thank you, Mr. Chairman. Mr. Klink.
Mr. Klink. Thank you, Mr. Chairman, for having this hearing
today.
This hearing is about whether medical devices we use in the
everyday practice of medicine are Y2K compliant and, if not,
what corrective actions we must take to make them so.
In short, today's hearing has both good news and bad news.
The goods news is that today, we now have much more information
on the Y2K problem and how it may affect certain medical
devices than we had only a couple of months ago. The bad news,
though, is that we still have a significant amount of
information to gather and much more work ahead of us, and the
clock and the calendar are running out on us.
Here is what we know so far about the biomedical side of
the Y2K problem: Within the past several months, thanks to the
help of the GAO, the FDA finally created a single, Internet-
accessible clearinghouse, so that providers could determine the
status of their existing inventories of medical equipment. To
complete this data base, the FDA identified about 2,300
companies that they believe might have a Y2K problem, and so
should be part of this data base.
The FDA then sent letters to, and attempted to contact
directly, as many as of the 2,300 potentially susceptible
companies as they could locate. Most of those responded to the
FDA in one form or another. But, about 200, for reasons
unknown, have yet to respond.
In discussions with the FDA and industry officials,
committee staff were told that none of the non-reporting 200
companies appear to be major equipment manufacturers; that is,
that they make medical equipment that could be life-threatening
if a Y2K problem exists.
FDA reported, in fact, that many of the companies may have
merged with others and, thus, may no longer exist, or may
really never have existed at all, and were placed in error on
the original list. Nevertheless, I would ask the FDA and the
device industry to continue to identify all of the companies on
this list, to try to determine with certainty that we are not,
somehow, missing any companies that may be making critical
equipment.
Of those that did report to the FDA's data base, some seem
to have few, or no, Y2K-related equipment problems, while
others have reported that some of their devices are affected by
the date change. For example, while a number of the original
2,300 companies reported that none of their products were Y2K-
susceptible, and thus, the FDA did not have to worry about
their status, about 300 companies have reported that about 1000
biomedical devices that they collectively manufacture do have a
Y2K problem.
Still another group, rather than listing information in the
FDA data base, has opted instead to link to each of their own
websites, where their equipment status can be identified. This
group of about 400 companies will most certainly report at
least some equipment requiring a Y2K fix.
What does this all mean? I believe that the group of
approximately 300 companies reporting about 1000 problems, and
the approximately 400 companies linking the FDA clearinghouse
to their own websites, must be the major focus of these
subcommittees' attention. What we can determine is that there
exists a rather sizable group of companies, and thus devices,
that do have Y2K problems. What we have not yet determined,
however, is the exact nature of this equipment and how it may
affect the healthcare delivery system of our Nation.
Quite simply, Mr. Chairman, we have begun to collect decent
Y2K data, but I don't think we have made full use of it. I
believe that this committee must work with the FDA and the GAO
and the device industry to make further sense of this data. We
presently know only that there are at least some Y2K problems
affecting some medical devices. We must go beyond this general
statement and place this problem into context. At a minimum, I
would like to know, No. 1, the nature of the equipment being
reported as having Y2K problems; No. 2, how the problem could
affect each piece of equipment, and No. 3, exactly how, and
when, the problem will be dispositioned by the manufacturer.
This is very achievable, I believe, in the limited months
remaining before the year's end.
So, Mr. Chairman, I don't think the sky is falling
regarding the Y2K safety of biomedical equipment but,
nevertheless, I am not fully comfortable with the present
status of this industry. In order to fully gain public
confidence, I think we must go further and truly attempt to
assess existing data to determine what areas are fully safe and
where we need to pay additional attention.
Let me conclude by saying that I will split the difference
between my good friends from GAO and what they have recommended
and what the FDA has approved, or has proposed.
Frankly, I don't think there is enough time or the
technical resources available at the FDA to undertake the kind
of verification measures the GAO advocates. Quite simply, I
don't believe the FDA is equipped to systematically review all
of the Y2K assessments made by the device manufacturers
reporting to the FDA's data base. Nevertheless, I do welcome at
least some additional checks on behalf of the FDA, particularly
in those areas where a serious Y2K problem has been identified
in a medical device that could cause life-threatening failure.
Scrutiny in such areas cannot be overdone, and I am willing
to work with our friends at both the GAO and the FDA and the
device industry itself to reach some accommodating measures.
So, Mr. Chairman, we have made significant progress in
these areas, but we have much more work ahead of us in the few
months ahead. I look forward to working with you and other
members of this committee and the witnesses before us today to
continue our efforts.
I would just like to mention my friend, Mr. Upton, and I
have been discussing, and I just bring this up publicly, we
also have grave interest, as technology moves forward, talking
about computers, and we would like subcommittee chairman
Bilirakis to work with us also, it has come to our attention
about the difficulties, right now, in reining in the sale of
some pharmaceutical problems over computers, some of them
without prescriptions, some of them being sold that are drugs
that are illegal in this country. We have talked about it, and
we want to bring you into that conversation. It is something
that both the majority and the minority have great interest in,
and we would like to be able also to pursue this together at
some future time, Mr. Chairman. With that, I yield back.
[The prepared statement of Hon. Ron Klink follows:]
Prepared Statement of Hon. Ron Klink, a Representative in Congress from
the State of Pennsylvania
Thank you Mr. Chairman for having this hearing.
Today's hearing is about whether the medical devices we use in the
everyday practice of medicine are Y2K compliant, and if not, what
corrective actions we must take to make them so. In short, today's
hearing has both good news and bad news: the good news is that today,
we now have much more information on the Y2K problem and how it may
affect certain medical devices than we had only a few months ago. The
bad news is that we still have a significant amount of information to
gather, and much more work ahead of us.
Here is what we know so far about the biomedical side of the Y2K
problem:
Within the past several months, thanks to the help of the GAO, the
FDA finally created a single Internet-accessible clearinghouse, so that
providers could determine the status of their existing inventories of
medical equipment.
To complete this database, the FDA identified about 2,300 companies
that they believed might have a Y2K problem, and so should be part of
this database. FDA sent letters to, and attempted to contact directly,
as many of the 2,300 potentially susceptible companies as it could
find. Most of these responded back to the FDA in one form or another.
Nevertheless, approximately 200, (for reasons unknown) have yet to
respond.
In discussions with FDA and industry officials, Committee staff
were told that none of the non-reporting 200 companies appear to be
major equipment manufacturers that make medical equipment that could be
life threatening if a Y2K problem exists. FDA reported, in fact, that
many of the companies may have merged with others and thus no longer
exist or may have never existed at all and were placed in error on the
original list.
Nevertheless, I would ask that the FDA, and the device industry
continue to try to identify all of the companies on this list to
determine with certainty that we are not somehow missing any companies
that may make critical equipment.
Of those that did report to FDA's database, some seem to have few
or no Y2K-related equipment problems while others have reported that
some of their devices are affected by the data change.
For example, while a number of the original 2,300 companies
reported that none of their products were Y2K susceptible, and thus the
FDA did not have to worry about their status, about 300 companies have
reported that about 1,000 biomedical devices they collectively
manufacture, have a Y2K problem. Still another group, rather than
listing information in FDA's database has opted instead to link to each
of their own websites where their equipment's status can be identified.
This group of about 400 companies will, with almost certainty, report
at least some equipment requiring a Y2K fix.
What does this all mean, Mr. Chairman?
I believe that the group of approximately 300 companies reporting
about 1,000 problems, and the approximately 400 companies linking the
FDA clearinghouse to their own websites, must be the major focus of our
attention. What we can determine is that there exists a rather sizeable
group of companies, and thus devices, that have a Y2K problem. What we
have not yet determined, however, is the exact nature of this equipment
and how it may affect the health care delivery system.
Quite simply, Mr. Chairman, we've begun to collect decent Y2K data,
but I don't think we've made full use of it.
Mr. Chairman, I believe that this Committee must work with the FDA,
the GAO, and the device industry, to make further sense of this data.
We presently know only that there are at least some Y2K problems
affecting some medical devices. We must go beyond this general
statement and place this problem into context. At a minimum, I would
like to know: (1) the nature of the equipment being reported as having
a Y2K problem; (2) how the problem could affect each piece of
equipment, and (3) exactly how and when the problem will be
dispositioned by the manufacturer.
This is very achievable in the limited months remaining before the
year's end.
Mr. Chairman, I don't think the sky is falling regarding the Y2K
safety of biomedical equipment. Nevertheless, I'm not fully comfortable
with the present status of this industry. In order to fully gain public
confidence, I think we must go further, and truly attempt to assess
existing data to determine what areas are fully safe, and where we need
to pay additional attention.
Finally, let me conclude by saying that I will split the difference
between what my good friends from GAO have recommended, and what the
FDA has proposed. Frankly, I don't think there's enough time, nor the
technical resources available at the FDA to undertake the kinds of
verification measures the GAO advocates. Quite simply, I don't believe
the FDA is equipped to systematically review all of the Y2K assessments
made by the device manufacturers reporting to FDA's database.
Nevertheless, I do welcome at least some additional checks on behalf of
the FDA, particularly in those areas where a serious Y2K problem has
been identified in a medical device that could cause a life threatening
failure. Scrutiny in such areas cannot be overdone and I am willing to
work with my friends at the GAO, the FDA, and the device industry
itself, to reach some accommodating measure.
Mr. Chairman, we've made significant progress in this area, but we
have much more work ahead of us. I look forward to working with you,
the other members of this Committee, and our witnesses before us today
to continue our efforts.
With that, I yield back.
Mr. Bilirakis. Thank you. Mr. Upton.
Mr. Upton. Thank you, Mr. Chairman. I would ask unanimous
consent that my lengthy opening statement be made part of the
record.
Mr. Bilirakis. With unanimous consent, all the lengthy
opening statements of the members of the two subcommittees will
be made a part of the record.
Mr. Upton. I would just like to add that I appreciate this
hearing by both of our two subcommittees and it stems from an
earlier hearing that we had about a month ago with regard to
billing within the health community and the Y2K problem.
This is a daunting task. In fact, a number of hospitals
across the country are spending perhaps as much as $1 million
to comply, to make sure that things work when the calendar page
turns.
Since FDA's clearinghouse began in 1998, they have heard
from some 4000 manufacturers regarding compliance, but there
are still hundreds that they have not heard from. As we all
know, there is no room for error. I recently spent the day with
one of my hospitals in Berrien County, Michigan, and looked at
virtually every sector of what they do to provide good
healthcare in our region. I can remember well a visit to the
renal dialysis facility where virtually every single one of the
booths was occupied. In fact, they said that they are occupied
for the complete day, 24 hours a day, 6 days a week, providing
assistance for folks, and there was no room even for visitors
to come in from other parts of the country that might be
visiting friends or families in our part of the State. If they
had a reason, or need, for renal dialysis, the answer would be
no.
With that type of occupancy, it is pretty clear that we
have to make sure that these machines and other devices work
within the hospitals and to try and get a better gauge of that.
I appreciate the hearing today and look forward to the
testimony from the witnesses, and I yield back the balance of
my time.
[The prepared statement of Hon. Fred Upton follows:]
Prepared Statement of Hon. Fred Upton, Chairman, Subcommittee on
Oversight and Investigations
Today, the Subcommittee on Oversight and Investigations and the
Subcommittee on Health and the Environment are holding a joint hearing
on the issue of the Year 2000 problem as it relates to medical devices.
Over the past several months, the Committee on Commerce has undertaken
an extensive review of the progress the Health Care Financing
Administration, or H-C-F-A, its Medicare contractors and its hospitals,
nursing homes, doctors and other providers have made in becoming Y-2-K
compliant. Last month, these two subcommittees held a hearing on the Y-
2-K status of Medicare providers and their billing and financial
systems.
Today, our hearing will focus on the status of medical devices.
Medical devices and equipment, such as cardiac monitoring systems,
cardiac defibrillators and x-ray machines, are critical to providing
health care treatment in a variety of health care settings. These
devices have the potential to adversely affect patient safety if they
perform any type of date or time calculation. The degree of risk
increases significantly if the machine is a critical care of life
support device.
Several weeks ago, the importance of ensuring that medical devices
and equipment are Y-2-K compliant really came home to me in a powerful
way. I toured a renal dialysis unit in St. Joseph/Benton Harbor,
Michigan, my home community, with a population of about 50,000. The
dialysis center operates 6 days a week, 24 hours a day, at full
capacity. It was during that visit that I learned that there was no
room for visitors to use this facility. Obviously, should this unit and
others in other communities across the nation fail to operate properly
on January 1, 2000, lives would be put in serious jeopardy.
I have been talking with hospitals in my Congressional district
about their Y-2-K efforts to ensure that their medical devices and
equipment are compliant, and I have learned a lot. First, the magnitude
of the effort is daunting. All of the hospitals inventoried their
devices as an initial step--one hospital system had 8000; another 5000.
The direct costs of reviewing critical devices and upgrading or
replacing those which are not compliant are also significant--$\1/2\ to
$1.0 million.
As a second step, each hospital contacted device manufacturers for
information on the device's Y-2-K compliance. All reported that
initially, they often had difficulty getting information, particularly
from smaller manufacturers. However, all have seen improvement and
greater cooperation in meeting the challenges of Y-2-K, particularly
with the creation of the FDA's central data base.
In 1997, the Food and Drug Administration, or F-D-A, began
collecting data from device manufacturers regarding the Y-2-K
compliance status of their devices. After several letters and a small
response rate from manufacturers, the F-D-A joined in partnership with
the Veterans Health Administration, the Department of Defense and the
Health Industry Manufacturers Association, to assemble a single
database clearinghouse. The goal of the clearinghouse was to provide a
centralized source of information on the Y-2-K compliance status of
biomedical equipment in the United States.
Since F-D-A's data clearinghouse began in September of 1998, they
have heard from 4,116 manufacturers regarding the compliance status of
their equipment. They are still awaiting information from another 232
manufacturers. Since F-D-A began its database, the flow of information
has increased significantly. However, the F-D-A has stated that they
are in no way ensuring that the information displayed on their
clearinghouse is accurate or complete. In other words, the
clearinghouse serves as a central point for data, but not a guarantee
by the F-D-A that the data provided is accurate or complete.
While information regarding medical devices continues to increase,
recent surveys conducted show that Medicare providers are still
expressing concern over the compliance status of their equipment. I
hope this hearing will demonstrate the need for all manufacturers to
release information to providers regarding the Y-2-K status of their
devices and equipment. It is crucial at the turn of the century that
service to Medicare beneficiaries is uninterrupted and patient safety
is not jeopardized.
I would like to welcome all of our panels here today to testify.
Thank you all for coming and appearing before us today.
Mr. Bilirakis. I thank the chairman. Mr. Brown.
Mr. Brown. Thank you, Mr. Bilirakis.
I would also ask to enter to my written statement into the
record.
I just have a couple of comments that are a bit off the
subject but I have not really heard much said during this whole
Y2K debate and I find it interesting that in our much vaunted
private sector in this country, where all wisdom begins and
ends, that all of the computer geniuses, in all of the large
companies that bought computer systems in the last 20 to 30
years, really did not anticipate this whole Y2K problem.
That companies that made billions of dollars, computer
executives that are worth hundreds of millions, billions of
dollars, in some cases, that companies where the purchasing
agents, and the vice presidents in charge of putting in these
computers, and buying these computers, made these purchases
without really anticipating what was going to happen in the
year 2000.
If that had been a government decision we would see
newspaper article after newspaper article criticizing big
government and telling us how government does nothing right in
this country, but since it was the much vaunted private sector
we have not really seen those kinds of newspaper articles.
I would imagine that that computer company executives that
created this problem, and did not foresee this problem until
not very many years ago, still got their bonuses and I would
imagine large companies that have had this, that bought these
computer systems and that installed them and did not warn their
CEOs about the Y2K problem until only a small number of years
ago still got their bonuses and were still doing very well,
thank you.
I just think it is important that as this country has
begun, in the last small number of years, to deal with Y2K, and
this Congress has been involved, that we are aware of some of
the history of this and we are aware that this problem is one
that has cost us so much money and has cost us so much time in
this Congress, and in the private sector, and the public sector
all over in dealing with it.
So, I thank the Chair and yield back the balance of my
time.
[The prepared statement of Hon. Sherrod Brown follows:]
Prepared Statement of Hon. Sherrod Brown, a Representative in Congress
from the State of Ohio
Thank you, Mr. Chairman. I'm pleased to participate in our second
joint hearing on Y2K issues, and I thank our distinguished panelists
for joining us.
Today's hearing is important from a number of perspectives: to the
extent the Year 2000 transition disrupts medical devices and the
production and distribution systems supporting them, health care
access, quality and continuity could all be affected.
According to FDA, there are more than 100,000 medical devices,
equipment ranging from tongue depressors to MRIs.
Fortunately, the great majority of these devices are not date-
dependent, and medical device manufacturers have been working hard to
ensure that the production and distribution systems around these
devices experience no disruption as we transition into the next
century.
I commend FDA, which has worked with the Department of Veterans
Affairs, the Department of Defense and the Health Industry
Manufacturers' Association to develop a clearinghouse for compliance
information.
One of the areas I hope today's witnesses will address involves
devices made by manufacturers who are no longer in business or who have
otherwise refused or have been unable to reply to FDA's request for
information. How do we ensure that there will be no harm done to
patients or disruption in the delivery of care?
I understand the response rate to FDA's clearinghouse information
request was strong--about 90%--but that some 399 device manufacturers
have not provided FDA any information.
I hope our witnesses also touch on areas we didn't explore during
the last hearing, including the implications of the Y2K transition for
non-hospital providers and their patients--areas such as home health
care and setting such as skilled nursing facilities and community
health clinics.
Today's hearing will provide valuable information in our continuing
examination of Y2K transition issues. I look forward to hearing your
comments.
Mr. Bilirakis. I thank the gentleman. Let's see, do we have
an order here? Mr. Bryant.
Mr. Bryant. Thank you, Mr. Chairman. Good morning.
I want to thank you and Chairman Upton, as well as Mr.
Brown and Mr. Klink, for holding this second hearing on the Y2K
bug and its potential effects on medical care.
As we are all aware, the clock is ticking. The countdown
continues to January 1, 2000. To be frank, I am concerned about
what is going on and what is going to happen with my friends,
relatives, and constituents who will need medical care at that
time. Will we be prepared?
For some people, the answer to that question will mean the
difference between life and death. For that reason, I am
looking forward to the hearing today and the testimony that we
will hear about the efforts of the manufacturers, and
healthcare providers, and those in government, to assess the
Y2K compliance of medical devices.
I sincerely hope that the news is encouraging, and taking
leave of my prepared statement just briefly, for those of you
who are prepared to testify, I would also like to hear
testimony about the potential liability issues out there. I
know in the Judiciary Committee we have looked at a Y2K
liability bill that, in fact, has been passed out of the House
of Representatives. And when it will be signed into law, I
don't know, but I have talked to some people in the medical
industry, particularly about the services in terms of their
potential exposure as to whether or not medical devices,
whether they take the assurance of the manufacturer, that it is
going to work. Should they, themselves, test it independently
of that and would they then incur liability for doing that
testing?
There are lots of intriguing issues, and I realize that you
did not come to testify specifically about that, but if you
have any statements that you would like to make public on the
potential impact of liability, I certainly would welcome those.
I would like to take a moment to welcome one of the
witnesses who will appear on the second panel, and I want to
particularly welcome her, Ms. Noel Brown Williams, of Columbia
HCA Healthcare Corporation, who is here this morning
representing the Federation of American Health Systems. I am
particularly pleased she is here because we have two hospitals
in my district from the Columbia system. One of those serves
the good people of Cheatham County. It is the Cheatham Medical
Center in Ashland City in Cheatham County, and the Horizon
Medical Center in Dickson, and I am very interested and pleased
with the progress that Columbia HCA hospitals have made, and
will continue to make, to ensure that patient care is not
compromised as we reach the turn of the century.
Again, Mr. Chairman, I want to thank all the witnesses for
their testimony and you for having this hearing, and I would
yield back.
Mr. Bilirakis. I thank the gentleman. Mr. Burr, for an
opening statement.
Mr. Burr. Thank you, Mr. Chairman. I will be brief.
I want to take this opportunity to thank all of the
witnesses who are here today.
A couple of the areas I want to concentrate on are the
distinction between urban and rural. Do we have the same
assurances with some of the rural facilities that their
equipment is as up-to-date, even though it may be much older
than equipment that we currently asked manufacturers about?
Another area of concern is, whose responsibility is it for
the end-to-end testing, if it is needed, for this equipment?
And, could this equipment be interconnected with other devices
where end-to-end testing becomes extremely important as to who
goes first?
I think that, Mr. Chairman, we all share the same common
goal, that is, to give America the assurance that healthcare
will go on uninterrupted. I have every reason to believe that
we have very capable people working on this, and the
clearinghouse certainly has produced good work.
We are reliant on manufacturers to share with us their
information as it relates to the Y2K problem. I remind all of
us that, just 6 months ago, most people thought that Y2K was a
spot remover. The reality is that we have all had a very steep
learning curve, but these agencies and this Congress must
assure the American people that their healthcare will be of the
same quality, and uninterrupted, as we head into the new
millennium.
I hope that we are further down that road when we complete
this hearing. I yield back.
Mr. Bilirakis. I thank the gentleman. Mr. Bilbray for an
opening statement. Dr. Ganske.
Mr. Ganske. Thank you, Mr. Chairman, for holding this
hearing. I think this is an important hearing, and I want to
build on the remarks that Congressman Bryant made related to
liability.
Last week, the House passed a liability relief for Silicon
Valley and for manufacturers. I voted against that bill because
I had some concerns, particularly for the users of those
products, many of whom are represented today whose patients are
going to be on ventilators, life-support, run with computer
chips.
Vern Ehlers tried to get an amendment made an order for
that bill that basically would have restricted the liability
relief for products made after 1995. That was not made an
order.
I sincerely hope that, when that Y2K liability bill comes
back from the Senate and from conference, that we take into
account the fact that, within that liability bill that we
passed, there is a 90-day moratorium on legal redress for
products that are not working because of their Y2K computer
chips. I mean, I don't think that a patient on a ventilator has
90 days.
I think the message should be to the manufacturers and to
the software Silicon Valley folks that we are not going to give
you liability relief. You know, we have about 8 months to get
this fixed, and there are going to be a lot of patients that
potentially could be harmed if we don't fix this Y2K problem.
So, I believe that we need to pass more wise legislation on
Y2K than what we have looked at so far in the House, and I will
also be interested, like Congressman Bryant, in comments from
members of the panels today on this issue.
Thank you very much.
Mr. Bilirakis. I thank the gentleman.
[Additional statements submitted for the record follow:]
Prepared Statement of Hon. Cliff Stearns, a Representative in Congress
from the State of Florida
I want to thank Chairman Bilirakis and Chairman Upton for holding
this important hearing today.
I believe we would all like to be assured that all medical devices
will be Y2K compliant.
What many people may not realize is that computer software is
frequently imbedded as a component of devices. For example, software
contained on a microchip to control a devices operation could deeply
impact individuals who rely upon their pacemakers, ventilators and
other life saving equipment for survival.
There is also the question of non-embedded software which is
usually operated on a personal computer. This would involve such
equipment as MRI's, Sonograms, X-rays, and CAT scans to name a few.
There are those who say there is too much hype about the Y2K
problem and that we don't need to worry. I disagree and look forward to
hearing from our distinguished panels about what they have done to
prevent any possible future catastrophes from occurring.
As Chairman of the VA Subcommittee on Health, I noted Mr. Hubbards'
comments about the Department of Veterans Affairs testimony before the
VA Subcommittee on Oversight and Investigations indicating they had
been assured by manufacturers that all the critical care devices are
expected to be in compliance by the year 2000. This is good news for
our nation's veterans. I was also pleased to learn about the
partnership between the VA and the FDA to develop a single data
clearinghouse for biomedical equipment year 2000 status information.
I also look forward to hearing Mr. Noel Williams' testimony since
several hospitals in my district are Columbia Health Care facilities.
In fact, Ocala Regional Medical Center is in my home town. The other
two HCA facilities are Putnam Community Hospital and Orange Park
Medical Center. It is very reassuring to know that Columbia/HCA began
planning for the Y2K problem back in 1996. Their efforts are to be
commended and should serve as a role model for those in the public and
private sectors that are not yet fully in compliance.
______
Prepared Statement of Hon. Karen McCarthy, a Representative in Congress
from the State of Missouri
Thank you Mr. Chairman. Today we are discussing the issue of
medical device Y2K compliance. We must ensure that medical devices that
are date sensitive are Y2K compliant, so that patients depending on
these devices are not adversely affected when the new year begins. I
would like to thank the witnesses who are testifying today. I look
forward to hearing your ideas about how to bring all medical devices
into Y2K compliance.
Many people do not realize the serious nature of the Y2K problem.
Dates are important to the functionality of many medical devices that
contain internal computer chips. Basically, anything that is electronic
is at risk for noncompliance. For example, in a Kansas City Star
article on May 23, 1999, Dr. Andrew V. Kauftnan, a Kansas City
neurosurgeon explains the importance of Y2K compliance for the gamma
knife. The gamma knife is a device used to treat brain tumors. A
computer chip in the knife determines the length of radioactive
exposure to the brain that is needed. Dr. Kaufman states, ``It has to
be perfect. We don't want to undertreat, because if we do, we are
inadequately treating the condition. Were we to overtreat, we run the
risk of brain injury or other complications such as brain swelling.''
Fortunately, preliminary tests have shown this device to be Y2K
compliant, but more tests will be conducted in the next 60 days to be
certain.
The costs associated with bringing medical devices into Y2K
compliance are high, and could be an insurmountable burden for smaller
hospitals. For example, Health Midwest of Missouri expects to spend 10
million dollars to check 21,000 biomedical devices. Because of these
high costs and also because of the potential crises that could arise as
a result of the failure of medical devices, we must explore contingency
plans for this issue. I look forward to hearing more about such
contingency plans as we continue this discussion.
I am eager to work with our witnesses and with my colleagues to
find a solution that will protect our nation's patients and provide a
fiscally responsible solution for the medical providers. Thank you. I
yield back the balance of my time.
______
Prepared Statement of Hon. Lois Capps, a Representative in Congress
from the State of California
Mr. Chairman, thank you for holding this important hearing to gain
insight on the Y2K compliance of medical devices. These devices, such
as cardiac defibrillators, pacemakers, and cardiac monitoring systems,
are all computer-run, and thus are subject to the Y2K bug. It is
imperative that we take a proactive stance on this matter.
The importance of this hearing is clear. Millions of people rely on
medical devices everyday, and the consequences of these machines not
working on January 1, 2000 would be devastating.
Pursuant to the Federal Food and Drug Act, it is the responsibility
of the FDA to ensure the safety and effectiveness of medical devices in
the marketplace. I know the FDA has tried, through various mail
campaigns and the Federal Year 2000 Biomedical Clearinghouse, to do
this as thoroughly as possible. However, the FDA heard back from less
than 10% of those doctors who were mailed these questionnaires, and the
success of the clearinghouse is so far indeterminate. It is clear that
there is much to be done.
I am eager to hear from our witnesses today, to see how we can all
work together to make sure the medical community is properly prepared
for the Year 2000. Again, I thank you, Mr. Chairman, for holding this
hearing, and I look forward to working with you.
Thank you.
Mr. Bilirakis. The Chair will now call for the first panel:
the Honorable William Hubbard, Acting Deputy Commissioner for
Policy with the U.S. Food and Drug Administration; Dr. Thomas
Shope, Special Assistant to the Director, Office of Science and
Technology Center for Devices and Radiological Health, U.S.
Food and Drug Administration, and Mr. Joel C. Willemssen,
Director, Civil Agencies Information Systems, Accounting and
Information Management Division of the General Accounting
Office.
The Chair now yields to his co-Chair, Mr. Upton.
Mr. Upton. Thank you. Panel, we have a longstanding
tradition in the Oversight and Investigations Subcommittee of
our witnesses being sworn under oath. Do any of you have any
objection to that, or problem with that?
[All witnesses shake head indicating no.]
And we also provide, under House rules, if you desire to
have counsel. Do you need to have a counsel for your questions?
[All witnesses shake head indicating no.]
If not, if you would stand and raise your right hand?
[Witnesses sworn.]
I yield back to the chairman. Thank you.
Mr. Bilirakis. I thank the chairman. Each of you is now
under oath. I am going to set the clock at 5 minutes.
Obviously, your written statement is a part of the record, and
we would hope you would complement it in your oral remarks. I
am going to set the 5-minute clock, but, obviously, if it takes
a little longer for you to get your message across, I want you
to feel free to do so. Let us see, I guess we will call on Mr.
Hubbard first.
TESTIMONY OF WILLIAM K. HUBBARD, ACTING DEPUTY COMMISSIONER FOR
POLICY, ACCOMPANIED BY THOMAS SHOPE, SPECIAL ASSISTANT TO THE
DIRECTOR, OFFICE OF SCIENCE AND TECHNOLOGY CENTER FOR DEVICES
AND RADIOLOGICAL HEALTH, FOOD AND DRUG ADMINISTRATION; AND JOEL
C. WILLEMSSEN, DIRECTOR, CIVIL AGENCIES INFORMATION SYSTEMS
ACCOUNTING AND INFORMATION MANAGEMENT DIVISION, GENERAL
ACCOUNTING OFFICE
Mr. Hubbard. Thank you, Mr. Chairman. As you said, Mr.
Chairman, we have a written statement which I will not read
today.
Let me first mention that I have Dr. Thomas Shope, from our
Center for Devices, and expert legal help with me today. He is
an expert in this matter.
What I will do, Mr. Chairman, is briefly give you some
sense of the many things that we have done in the FDA on this
issue thus far. We have sent a number of letters to the
industry giving them advice and advising them of what they need
to do on the worry about this problem, to make sure that their
products are Y2K compliant. We have given written guidance to
the industry that spells out certain procedures that they need
to follow. Our field staff has asked the right questions; we
have inspected device firms, and we believe we are helping in
that way. We have done a substantial amount of outreach to the
industry, Mr. Chairman, with press contacts and speeches and
meetings and mailings and articles and lots of other things to
make sure that the industry and hospitals know what to look for
here.
We have developed a rapid response plan so, as the year
progresses, if there are problems with these devices, our field
force and our headquarters' specialists will be able to jump in
right away. As a matter of fact, that program will be staffed
on a 24-hour basis beginning in the fall.
We have developed, as you know, a biomedical equipment
clearinghouse, a website, which initially listed all of the
non-compliant medical devices, and now is attempting to list on
that website compliant devices, so that the public, the
hospitals, the physicians, and others will be able to access it
readily.
We have worked with the VA and the hospitals to help
identify critical devices that, if they fail, would be a
problem. We have tried to identify those devices that might
present a high risk to patients if they were not compliant and
fail for that reason. We are pursuing those most vigorously.
All of these activities, Mr. Chairman, have led us to a
fairly high degree of confidence that no serious problems exist
from medical devices and that, as the year progresses, and we
go into the first of the year, there won't be a problem.
Nevertheless, Mr. Chairman, our colleagues at the GAO have
recommended that we take an additional step, the auditing of
manufacturers' records, demonstrating that they have verified
that no problem will exist and that a fix has been properly
implemented, if a problem did exist for a given device.
The GAO believes that this additional step will provide
assurance to the agency, hospitals, and the public that certain
potentially high-risk devices will function properly at the
turn of the century. We, of course, respect that view and have
the clue that such a program could, feasibly, be constructed.
We believe somewhere over 300 firms make these so-called
potentially high-risk devices, the sort of devices that, if
they failed, could cause serious injury to patients.
So, we propose to begin in June an audit program that would
have contractors, hired by the FDA, specialists in this area,
go to manufacturers and review their records and ascertain
that, in fact, they have asked the right questions, done the
proper validation and verifications, and have the proper
paperwork to demonstrate that that is the case; Where there was
a device that was not compliant, that they have done the
necessary upgrades and properly implemented those.
We would propose, Mr. Chairman, to phase this concept in.
As I said, there are somewhere over 300 manufacturers. so the
concept would be to perhaps do a representative sample of
perhaps 60 manufacturers initially, and if we found no problems
with those, we would then consult with others and reassess
whether we should go do the entire universe of these particular
manufacturers. and, of course, if problems were found in that
representative sample, we would be prepared, of course, to go
to all these manufacturers and do the same sort of audit for
those.
With that, Mr. Chairman, briefly, I hope I have given you a
sense of where we are, and I would be glad to answer any
questions you have.
[The prepared statement of William K. Hubbard follows:]
Prepared Statement of William K. Hubbard, Acting Deputy Commissioner
for Policy, Food and Drug Administration, Department of Health and
Human Services
introduction
Good morning, my name is William Hubbard. I am the Acting Deputy
Commissioner for Policy, Food and Drug Administration (FDA or the
Agency). I am pleased to be here today to provide information on the
Year 2000 date issue as it relates to medical devices. FDA has taken a
number of constructive actions to work with manufacturers and provide
information to users about medical device Year 2000 compliance.
FDA promotes and protects public health by helping to ensure that
medical devices are safe and effective. The Center for Devices and
Radiological Health (CDRH) is the component of FDA that has
responsibility for regulating medical devices. CDRH helps carry out the
Agency's mission by evaluating new products to determine if they can be
marketed; assuring quality control in manufacture through inspection
and compliance activities; monitoring adverse events in already
marketed products; and taking action, when necessary, to prevent injury
or death. A device manufacturer must comply with all applicable
requirements of the Federal Food, Drug, and Cosmetic (FD&C) Act,
including, but not limited to, establishment registration and device
listing, premarket review, use of good manufacturing practices, and
reporting adverse events.
what is a medical device?
According to the definition in the FD&C Act, a ``device'' is:
an instrument, apparatus, implement, machine, contrivance,
implant, in vitro reagent, or other similar or related article,
including any component, part or accessory, which is intended
for use in the diagnosis of disease or other conditions, or in
the cure, mitigation, treatment, or prevention of disease, in
man or other animals, or intended to affect the structure or
any function of the body and which does not achieve its primary
intended purposes through chemical action and which is not
dependent upon being metabolized for the achievement of its
primary intended purposes.
As this definition suggests, many different types of products are
properly regulated as medical devices. Medical devices include over
100,000 products in more than 1,700 categories. The products regulated
by FDA as medical devices range from simple everyday articles, such as
thermometers, tongue depressors, and heating pads, to the more complex
devices, such as pacemakers, intrauterine devices, diagnostic imaging
devices, and kidney dialysis machines.
Any computer software which meets the legal definition of a medical
device is within the scope of the law and must comply with applicable
FDA regulations. Medical devices which use computers or software can
take several forms including: products containing embedded microchips
which are part, or components, of the devices; devices employing non-
embedded software which is used with, or to control, the devices or to
record data from the devices; or individual software programs that use
or process patient data to reach a diagnosis, aid in therapy, or track
donors and products.
A. Embedded Computer Software
Computer software frequently is embedded as a ``component'' of
devices, i.e., software contained on a microchip to control device
operation. Examples of such common, important devices are pacemakers,
infusion pumps and ventilators. The majority of these products will not
be affected by the Year 2000 problem since almost none of them require
knowledge of the current date to operate safely and effectively. For
example, pacemakers do not use the current date in their operation.
B. Non-embedded Computer Software
Non-embedded software is intended to be operated on a separate
computer, often a personal computer or work station. Such software
devices may be used to control or enhance the operation of another
device or devices and, further, may use the two-digit year format. It
is possible that non-embedded software devices may rely on date
information for proper operation and might be affected by the Year 2000
date change if not designed appropriately.
An example of non-embedded software is a computer program used to
plan radiation therapy treatments delivered using radioactive isotopes
as the radiation source (teletherapy or brachytherapy). These
treatments possibly could be affected if the computer program that
calculates the radiation dose parameters uses only a two-digit year
representation. The calculation of the length of time since the source
was last calibrated could be in error and thus lead to an incorrect
treatment prescription.
Other examples of uses of non-embedded software devices include:
conversion of pacemaker telemetry data; conversion, transmission, or
storage of medical images; automated analysis and interpretation of ECG
data; programming or control of rate response for a cardiac pacemaker;
perfusion calculations for cardiopulmonary bypass; and calculation of
bone fracture risk from bone densitometry data. Since there is a chance
that the two-digit format may affect the performance of these software
devices, FDA believes that the Year 2000 risk requires that healthcare
facilities take steps to identify and mitigate such problems through
proactively working with manufacturers.
fda efforts to address year 2000 issue
Year 2000 Database
In order to give the general public, government agencies, and the
healthcare and research communities one comprehensive source of
publicly available information on the Year 2000 compliance status of
biomedical equipment, the Federal Year 2000 Biomedical Equipment
Clearinghouse database was established in March 1998 and is available
to facilities via the World Wide Web. The Biomedical Equipment
Clearinghouse provides Year 2000 product status information in five
categories including: products that are Year 2000 compliant; products
that do not use a date; products that have a date related problem;
products whose status is provided on the manufacturer's website; and
identification of manufacturers for whom no information is available
(nonrespondents to FDA requests).
The Biomedical Equipment Clearinghouse database is being maintained
by FDA on its World Wide Web site at the request of the Interagency
Biomedical Equipment Working Group. This Working Group was organized
early in 1997 under the Subcommittee on the Year 2000 of the Chief
Information Officers' Councils. The database can be found on the
Internet at: http://www.fda.gov/cdrh/yr2000/. Manufacturers also may
submit a World Wide Web link to their own website, if they so choose,
where the requested information is provided to the public.
FDA and the Department of Veterans Affairs (DVA) have worked in
partnership to develop a single data clearinghouse for biomedical
equipment Year 2000 status information. DVA, as a purchaser of medical
devices, collected information from its vendors as to the compliance
status of the medical devices used in its facilities. This data, along
with data from the Department of Defense, has been provided to FDA and
following confirmation by FDA, has been added to the clearinghouse
database. Both FDA and DVA are working with private sector associates,
mostly professional associations and organizations such as the American
Medical Association, the American Hospital Association, the Joint
Commission on Accreditation of Healthcare Organizations, the Health
Industry Manufacturers Association (HIMA), the Medical Device
Manufacturers Association (MDMA), and the National Electrical
Manufacturers Association (NEMA) that provide advice and assistance as
requested.
recent letters to manufactures
A. March 29, 1999 Letter on Year 2000 Compliant Products
Biomedical equipment users have expressed the need for specific
information on all Year 2000 vulnerable products that are compliant and
have urged the establishment of a single, comprehensive source for this
information. On March 29, 1999, FDA issued a letter requesting that
medical device manufacturers submit a complete list of individual
product models that are Year 2000 compliant to the FDA-operated Federal
Year 2000 Biomedical Equipment Clearinghouse. Many biomedical equipment
users have told FDA that a single statement that all of a
manufacturer's products are Year 2000 compliant does not meet their
need to have affirmatively identified specific compliant equipment.
Once information on compliant products is received from medical device
manufacturers it will be made available, with improved search tools, as
part of the Biomedical Equipment Clearinghouse.
This database of Year 2000 compliant products is intended to
provide information on products that biomedical equipment users might
consider to be vulnerable to date-related problems because these
products could utilize software, a computer or microprocessor control.
Accurate Year 2000 status information on these products is critical to
these users as they evaluate their product inventory and plan any
needed remedial actions.
B. March 29, 1999 Letter on Interim Inspectional Policy Regarding Y2K
Issues.
On March 29, 1999, the Director, Division of Emergency and
Investigational Operations, Office of Regulatory Affairs (ORA), issued
a memorandum to the FDA field instructing investigators to raise the
awareness of potential Year 2000 problems to firms during FDA
inspections. In this letter, ORA expanded the Year 2000 activities to
include asking questions regarding what the firm has done to assure
themselves that their computer controlled/date sensitive products,
manufacturing processes and distribution systems are Year 2000
compliant, and to include information on this subject in their
Establishment Inspection Reports when relevant. In addition, if the
investigators encounter serious problems or concerns, or find the firm
is not taking appropriate steps to avoid serious Year 2000 problems,
this information must be reported to appropriate District and Center
personnel.
C. January 13 and March 3, 1999 Letters on Non-Compliant Products
On January 13, 1999, FDA issued a letter to device manufacturers
announcing FDA's intent to expand the product information maintained on
the FDA-operated Federal Year 2000 Biomedical Equipment Clearinghouse
and requested the continued cooperation of biomedical equipment
manufacturers in this effort. The letter requesting this information
was issued on March 3, 1999. In this letter FDA indicated that in some
of the manufacturer responses to the earlier requests the information
on the FDA website was not sufficiently detailed to adequately assist
facilities in assessing the impact of non-compliant products. FDA
requested that biomedical equipment manufacturers carefully review the
Year 2000 status information that they have provided or intended to
submit, and, where necessary, provide more specific information on non-
compliant products.
previous letters to manufacturers
A. June 25, 1997 Notification to Manufacturers
In light of the review of the impact of the Year 2000 on some
medical device computer systems and software applications, FDA has been
actively alerting the medical device industry through a series of
letters to medical device manufacturers for approximately two years.
The first alert letter was sent on June--5, 1997, to all CDRH
registered medical device manufacturers (8,322 domestic and 5,085
foreign) indicating that manufacturers needed to address this issue and
review both embedded and non-embedded software products. FDA reminded
manufacturers that, in addition to potentially affecting the
functioning of some devices, the two-digit year format also could
affect computer-controlled design, production, or quality control
processes. FDA requested that manufacturers review the software used in
medical devices to determine if there is any risk.
Device manufacturers who identify products that have a date-related
problem are required to take appropriate action to remedy the problem.
An example of appropriate action in some instances would be
notification to device purchasers so that their devices can be
appropriately modified before the year 2000.
B. January 21, 1998 Request for Information
In a letter dated January 21, 1998, Department of Health and Human
Services (DHHS) Deputy Secretary Kevin Thurm asked approximately 16,000
medical device and biomedical equipment manufacturers to voluntarily
provide information on the Year 2000 compliance status of their
products. Included in the mailing were all FDA registered manufacturers
without respect to the specific kind of device produced, even though
FDA estimates that only approximately 2,000 manufacturers make products
listed in the categories which include computerized products
potentially sensitive to Year 2000 problems. Approximately 3,000 of the
manufacturers included in the mailing are not regulated by FDA; for
example, scientific instrument manufacturers. The letter detailed
instructions on ways to submit the data requested and explained that to
be Year 2000 compliant products must function as intended regardless of
the date. Manufacturers also were given the opportunity to certify that
their products are not affected, if that is the case, or certify that
none of their products use computers or date information.
C. Targeted Follow-up with Manufacturers of Computerized Devices
On June 29, 1998, FDA issued a targeted, follow-up letter to
specific manufacturers of computerized devices urging them to respond
to our January 21 request to submit product data. This list was derived
from the names of those firms which have registered as manufacturers of
devices in the categories where Year 2000 vulnerability is likely.
Then on September 2, 1998, FDA issued a follow-up to the June 29,
1998 letter, directed to the manufacturers of potentially computerized
devices who had not responded to the previous requests to specific
manufacturers for information on the Year 2000 status of their devices.
In the letter, FDA requested that the manufacturers respond to FDA
within two weeks with the Year 2000 compliance status of their devices,
or at least indicate that a complete response was being developed.
On August 14, 1998, Dr. Bruce Burlington, then Director, CDRH, and
on September 2, 1998, Dr. Friedman, then Acting Commissioner of the
Food and Drug Administration, issued letters to HIMA requesting that
HIMA take aggressive and immediate actions to encourage and assist
medical device equipment manufacturers in providing information to FDA
about the Year 2000 compliance status of their products.
In late September 1998, FDA decided that it would be useful to
provide an indication of whether a particular manufacturer of
computerized devices potentially susceptible to Year 2000 concerns has
or has not provided information on Year 2000 compliance. To that end,
FDA posted on the website those manufacturers of selected product
categories which are likely to include vulnerable products that had not
provided a response to FDA's inquiries. FDA will continue to work with
manufacturers to obtain this data and report to Congress on the status
of these Year 2000 requests.
additional outreach and guidance
In addition to the website and the letters, CDRH has been
conducting extensive outreach to the device industry and to other
consumers on this issue. CDRH's Division of Small Manufacturers
Assistance provided an article entitled ``Biomedical Equipment
Manufacturers Urged to Share Year 2000 Information'' to 12 medical
device trade press contacts and to 65 U.S. and 35 foreign medical
device trade associations in order to facilitate the dissemination of
information to their members regarding the website database and to
encourage the posting of data by manufacturers. The website and
database were mentioned in the FDA Column of the June 3, 1998, Journal
of the American Medical Association and in an article in FDA's Medical
Bulletin that was sent to approximately 700,000 healthcare
practitioners this past summer.
In the Spring of 1998, CDRH developed a Guidance Document on FDA's
expectations of medical device manufacturers concerning the Year 2000
date problem. The guidance is available on the FDA website. The
guidance was published in the Federal Register on June 24 for greater
dissemination. The guidance re-emphasizes the provisions in existing
regulations that require manufacturers to address any date problems
which may present a significant risk to public health.
FDA also developed an article addressed to the users of radiation
treatment planning systems regarding the need to assess these systems.
The article was published in the newsletters of relevant professional
associations. Staff of CDRH have participated in numerous conferences
and video teleconferences devoted to the Year 2000 problem in
healthcare in order to communicate with healthcare facilities regarding
the Biomedical Equipment Clearinghouse and the need to address the Year
2000 issue with devices.
Although most devices are regulated by CDRH, FDA's Center for
Biologics Evaluation and Research (CBER) regulates blood bank software,
which is of particular concern for potential Year 2000 problems. In
January 1998, CBER posted guidance for industry entitled ``Year 2000
Date Change for Computer Systems and Software Applications Used in the
Manufacture of Blood Products'' on the FDA website. The guidance
provided specific recommendations to assist industry in its evaluation
of computer and software systems used in the manufacture of blood
products and to assist in evaluating the impact of potential Year 2000
problems.
what is the data telling us thus far?
As indicated above, FDA believes that approximately 2,000
manufacturers may produce equipment that may be affected by the Year
2000 problem. As of May 18, 1999, FDA has entered a total of 4,133
responses from the 16,000 manufacturers originally contacted. The data
from all of these manufacturers who have responded have been entered
into the database on the FDA website. These numbers change daily as
data are entered, corrected or even removed at the request of
manufacturers. Of the 4,133 manufacturers who have responded, 3,401
have reported that their products do not use daterelated data or all of
their products are compliant. Six hundred and sixty-one manufacturers
[312 manufacturers listed on the FDA website and 349 manufacturers
listed on the manufacturer's website] have reported one or more
products with date-related problems. Four hundred and twenty
manufacturers have provided World Wide Web links (URLs) to data
provided on their own manufacturer-operated websites. There are a few
submissions in which the data were incomplete or unclear in some
manner. FDA is communicating with these manufacturers to obtain
clarification before entering the information into the database. FDA
will continue to post additional responses as they are received.
In reviewing the data received from the manufacturers so far, FDA
sees no indication of widespread problems which will place patients at
risk, if and only if the solutions being developed and offered by
manufacturers are implemented as they have indicated. Of course, FDA
can not make assurances about manufacturers who have not reported
product status. FDA believes that the information received to date
confirms our original expectation that the Year 2000 problems with
medical devices will not be significant or widespread if facilities
take appropriate actions to address this issue. There will be specific
problems which need correction; however, the current assessment is that
they are much more likely to disrupt patient care rather than be of
direct danger to patients. Nonetheless, such disruption could be
serious and the potential for it to happen certainly merits rigorous
attention to the problem.
One indication of FDA's belief that Year 2000 problems are not
significant or widespread has been borne out by DVA in their testimony
and responses to questions before the House Committee on Veterans'
Affairs, Subcommittee on Oversight and Investigations. The DVA
indicated that they had received answers from manufacturers on all of
the critical care device components and they expected to be ready for
Year 2000.
Legal Authority
FDA's Quality System Regulation (QSR) (21 CFR 820) places on
manufacturers an ongoing responsibility to take corrective and
preventive actions that may include recall for problems with current
production. Devices automated with computer software are subject to all
requirements of Title 21, Code of Federal Regulations (CFR), Part 820,
unless expressly exempted by regulation. The regulation puts in place a
system whereby manufacturers must incorporate a set of procedures and
processes in their design and manufacturing activities to assure that
products being manufactured are safe, effective finished products. The
QSR regulation does not require the submission of any reports to FDA,
however, it does require firms to maintain internal procedures and
documentation of corrective and preventive actions (21 CFR 820.100).
The Removals and Corrections Regulation (21 CFR 806) requires
manufacturers to submit reports to FDA. In order to be reportable, a
Year 2000 problem must pose a ``risk to health'' as defined in section
806.2(j). Many of the problems reported in the Biomedical Equipment
database or on manufacturers' Year 2000 Web pages concern date
recording or display problems that are readily apparent to the user and
are unlikely to pose a risk to health. In the Year 2000 context, a
decision to correct a problem may occur long before the correction
itself is actually announced to customers. Once the decision for action
is made, however, and if the action is to correct a risk to health,
then the firm has 10 working days to notify the Agency through a report
of correction or removal. A firm that previously notified FDA about a
removal or correction through a Medical Device Report (under 21 CFR
803) does not have to submit an additional report under 21 CFR 806.
FDA will continue to emphasize to manufacturers the importance of
reporting on the Year 2000 compliance status of their products and take
additional steps to boost the response rate. Healthcare facilities need
information from all manufacturers to properly prepare and plan for any
actions they need to take to assure their devices needing corrections
or updates receive these well before the Year 2000.
conclusion
Thank you for the opportunity to update you about the issue of the
Year 2000 and medical devices. Let me assure you that FDA takes this
issue very seriously and is committed to a scientifically sound
regulatory environment which will help provide Americans with the best
medical care. In the public interest, FDA's commitment must be coupled
with a reciprocal industry commitment: that medical device firms will
meet high standards in the design, manufacture, and evaluation of their
products. FDA recognizes that this can only be attained through a
collaborative effort--between government and industry--grounded in
mutual respect and responsibility. The protections afforded the
American consumer, and the benefits provided the medical device
industry, cannot be underestimated.
FDA will continue to provide any assistance it can to address
specific problems that any other agency, such as the DVA, identifies.
FDA also is working with other agencies, patient groups, medical
associations and industry to optimize data collection and information
sharing. FDA will continue urging manufacturers to ensure the continued
safety and effectiveness of their medical devices by ensuring that
their devices can perform date recording and computations that will be
unaffected by the Year 2000 date change.
Thank you for the opportunity to testify.
Mr. Bilirakis. Thank you very much, sir.
Dr. Shope, I know you are not prepared to give an opening
statement, but do you have anything you would like to add to
what Mr. Hubbard has said, at least at this point?
Mr. Shope. No, Mr. Chairman, I think we will just respond
to questions.
Mr. Bilirakis. Okay. Mr. Willemssen, please proceed, sir.
TESTIMONY OF JOEL C. WILLEMSSEN
Mr. Willemssen. Thank you, Mr. Chairman, Chairman Upton,
Ranking Member Brown, members of the subcommittees. Thank you
for inviting us to testify today. As requested, I will briefly
summarize our statement.
As you have noted, biomedical equipment that uses a
computer or embedded chip to perform date or time calculations
can be susceptible to a Y2K problem. The significance of that
problem can range from a nuisance to the more serious, with a
potential to decrease patient safety.
FDA has made progress in obtaining Y2K compliance
information from manufacturers in establishing its biomedical
equipment clearinghouse. As of May 10, over 4,000 biomedical
equipment manufacturers have submitted data to that
clearinghouse. About 60 percent reported having products that
do not use a date, while about 8 percent reported having date-
related problems. FDA is now in the process of getting more
detailed information that is product-specific and plans to put
that on its website.
Less progress has been made in reviewing biomedical
equipment test results. Last year, we recommended that HHS take
steps to review manufacturers' compliance test results for
critical-care and life-support biomedical equipment, to give
the public additional assurance that these items would work as
expected, come January 2000. However, at that time in response
to our report, HHS had said that submitting compliance
certifications alone was sufficient.
What we have found, in contrast to that position, was that
some hospitals were actually going out and testing their own
biomedical equipment. They felt it was necessary to prove that
they had exercised due diligence in the protection of patient
health and safety. Hospital officials, in some cases, have told
us that their testing has identified some non-compliant
equipment that manufacturers had certified as compliant.
We recently met with HHS and FDA to discuss options for
reviewing test results, and we are pleased to hear in its
testimony today that FDA is moving out in this regard. I think
it will provide you, the Congress, and the American public with
greater assurance that biomedical equipment items, especially
critical-care and life-support items, will work as intended
come the turn of the century.
Now, while there is much information now available on
biomedical equipment, it is still not clear how extensively
healthcare providers are using this available information.
According to the FDA, it has taken steps to make users aware of
the clearinghouse. More than 100,000 inquiries have been made.
However, according to FDA it is not possible to determine the
source of the inquiries.
Further, of the Y2K health surveys we reviewed, only the
AMA survey mentioned the FDA clearinghouse, and for the AMA
survey only 11 percent of the respondents indicated they were
aware of the FDA clearinghouse.
Other information contained in available surveys is also
not encouraging. For example, less than one-third of hospitals
responding to the survey of the HHS Inspector General stated
that the biomedical equipment was compliant, while only 6
percent of hospitals responding to an American Hospitals
Association survey said their equipment was compliant. It is,
therefore, quite apparent that there is a great deal of work
remaining in a relatively short amount of time. That concludes
the summary of my statement, and I would be pleased to address
any questions you may have.
[The prepared statement of Joel C. Willemssen follows:]
Prepared Statement of Joel C. Willemssen, Director, Civil Agencies
Information Systems, Accounting and Information Management Division,
General Accounting Offive
Messrs. Chairmen and Members of the Subcommittees: We are pleased
to be here today to discuss the Year 2000 (Y2K) compliance status of
biomedical equipment.<SUP>1</SUP> The question of whether medical
devices such as magnetic resonance imaging (MRI) systems, x-ray
machines, pacemakers, and cardiac monitoring equipment can be counted
on to work reliably on and after January 1, 2000, is obviously of
critical importance to our nation's health care. To the extent that
biomedical equipment uses computer chips, it is vulnerable to the Y2K
problem.<SUP>2</SUP> In the medical arena, such vulnerability carries
with it possible safety risks.
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\1\ Biomedical equipment refers both to medical devices regulated
by the Food and Drug Administration (FDA), and scientific and research
instruments, which are not subject to FDA regulation.
\2\ The Y2K problem will affect everyone because it is rooted in
how dates are recorded and computed. For the past several decades,
computer systems have typically used two digits to represent the year,
such as ``98'' for 1998, in order to conserve electronic data storage
and reduce operating costs. In this format, however, 2000 is
indistinguishable from 1900 because both are represented as ``00.'' As
a result, if not modified, systems or applications that use dates or
perform date- or time-sensitive calculations may generate incorrect
results beyond 1999.
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Responsibility for oversight and regulation of medical devices,
including the impact of the Y2K problem, lies with FDA--an agency
within the Department of Health and Human Services (HHS). FDA is
collecting information from medical device and scientific and research
instrument manufacturers, and providing this information through an
Internet World Wide Web site. In addition, the Veterans Health
Administration (VHA) <SUP>3</SUP>--a key federal health care provider--
has taken a leadership role in determining the Y2K compliance status of
biomedical equipment by sharing the information obtained from
manufacturers with FDA.
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\3\ A component of the Department of Veterans Affairs (VA).
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My testimony today will discuss (1) the status of FDA's Federal Y2K
Biomedical Equipment Clearinghouse, (2) HHS' and VA's positions on our
recommendation to obtain and review the test results supporting
manufacturers' compliance certifications for critical care/life support
medical devices, and (3) information on the biomedical equipment
compliance status of health care providers.
background
Biomedical equipment is indispensable; it plays a central role in
virtually all health care. It is defined as any tool that can record,
process, analyze, display, and/or transmit medical data--some of which
may include medical devices, such as pacemakers, that are implanted in
patients--and laboratory research instruments, such as gas
chromatographs <SUP>4</SUP> and microscopes. Such equipment may use a
computer for calibration or for day-to-day operation. If any type of
date or time calculation is performed, susceptibility to a Y2K problem
exists, whether the computer is a personal computer that connects to
the equipment remotely, or a microprocessor chip embedded within the
equipment itself. This could range from the more benign--such as
incorrect formatting of a printout--to the most serious--incorrect
operation of equipment with the potential to decrease patient safety.
The degree of risk depends on the role of the equipment in the
patient's care.
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\4\ Such instruments are used to separate the components of a
solution with heat and measure their relative quantities.
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According to officials at VHA, biomedical equipment manufacturers
reporting products as noncompliant most frequently cite incorrect
display of date and/or time as the main problem. For example, a
noncompliant electrocardiograph machine, used to monitor heart signals,
would print charts with two-digit dates, showing the year 2000 as
``00.'' According to a VHA official, these cases generally do not lead
to the devices' failing to operate and do not present a risk to patient
safety because health care providers, such as physicians and nurses,
are able to work around such problems.
However, VHA recognizes that incorrect date-time representation or
use could pose a risk when the date is used in a calculation, or when
records generated by the equipment are sorted automatically to present
a picture of a patient's condition over time to a physician for
diagnosis and treatment. Specifically, when records are sorted by date
of recording, the accuracy of such dates can be critical to a
physician's monitoring of patient progress in, for instance, the case
of blood sugar readings. If readings were taken, for example, on
December 25, 27, and 30, 1999, and again on January 1, 2000, the
ordering might appear with the last entry first if it were abbreviated
``00'' and read as January 1, 1900. If the physician or other clinician
did not pay close attention, a diagnosis or treatment decision could be
made based on a misreading of the data trend.
VHA also recognizes that an equipment function that depends on a
calculation involving a date, and that is performed incorrectly as the
result of a date problem, could present a risk to the patient. Examples
of such equipment include a product used for planning the delivery of
radiation treatment using a radioactive isotope as the source. An error
in the calculation of the radiation source's strength on the day the
therapy is to be delivered could result in a dose that is either too
low or too high, which could have an adverse impact on the patient.
Other examples of equipment presenting risk to patient safety--
identified by FDA--include hemodialysis delivery systems; therapeutic
apheresis systems; <SUP>5</SUP> alpha-fetoprotein kits for neural tube
defects; <SUP>6</SUP> various types of medical imaging equipment; and
systems that store, track, and recall images in chronological order.
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\5\ Such equipment allows therapeutic apheresis--the exchange or
purification of blood plasma. Therapeutic apheresis is recognized as a
successful treatment for more than 40 autoimmune diseases.
\6\ Devices that use computer calculations of gestational status to
help assess the risk of neural tube defects in the fetuses of pregnant
women.
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much biomedical equipment status information available in fda
clearinghouse
Last September we testified that FDA was trying to determine the
Y2K compliance status of biomedical equipment.<SUP>7</SUP> FDA's goal
was to provide a comprehensive, centralized source of information on
the compliance status of biomedical equipment used in the United States
and make this information publicly available on a web site. However, at
the time, FDA had a disappointing response rate from manufacturers to
its letter requesting compliance information. And while FDA made this
information available to the public, it was not detailed enough to be
useful. Specifically, FDA's list of compliant manufacturers lacked
detailed information on the make and model of compliant equipment.
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\7\ Year 2000 Computing Crisis: Leadership Needed to Collect and
Disseminate Critical Biomedical Equipment Information (GAO/T-AIMD-98-
310, September 24, 1998).
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To provide more detailed information on the compliance status of
biomedical equipment, as well as to integrate more detailed compliance
information already gathered by VHA, we recommended that HHS and VA
jointly develop a single data clearinghouse to provide such information
to all users. We said development of the clearinghouse should involve
representatives from the health care industry, such as the Department
of Defense's Office of the Assistant Secretary of Defense (Health
Affairs) and the Health Industry Manufacturers Association. We
recommended that the clearinghouse contain compliance status
information by product make and model, and identify manufacturers that
are no longer in business. Finally, we recommended that FDA and VHA
determine what actions should be taken regarding biomedical equipment
manufacturers that had not provided compliance information.
In response to our recommendation, FDA--in conjunction with VHA--
established the Federal Y2K Biomedical Equipment
Clearinghouse.<SUP>8</SUP> With the assistance of VHA, the Department
of Defense, and the Health Industry Manufacturers Association, FDA has
made progress in obtaining compliance status information from
manufacturers. For example, according to FDA, 4,116 biomedical
equipment manufacturers had submitted data to the clearinghouse as of
May 10, 1999. As shown in figure 1, about 60 percent reported having
products that do not employ a date, while about 8 percent reported
having date-related problems such as incorrect display of date/time.
Also, according to FDA, 232 manufacturers have not yet responded.
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\8\ The clearinghouse can be found on the World Wide Web at http://
www.fda.gov/cdrh/yr2000/year2000.html.
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Figure 1: Biomedical Equipment Compliance-Status Information Reported
to FDA by Manufacturers as of May 10, 1999.
[GRAPHIC] [TIFF OMITTED] T7443.001
Note: Total number of manufacturers = 4,116.
Source: FDA.
In addition, FDA did not have complete information on the number of
products with date-related problems because some manufacturers did not
clearly identify their products this way in their original submissions.
However, according to FDA, on March 3, 1999, it requested information
on specific product types for products with date-related problems. FDA
told us it is now receiving updated data.
Also, in response to our recommendation, FDA has expanded
information in the clearinghouse; users can now find information on
manufacturers that have merged with or have been bought out by other
firms. Further, in collaboration with the National Patient Safety
Partnership, <SUP>9</SUP> FDA is in the process of obtaining more
detailed information from manufacturers on noncompliant products, such
as descriptions of the impact of the Y2K problem on products left
uncorrected. FDA also sent a March 29, 1999, letter requesting that
medical manufacturers submit to the clearinghouse a complete list of
individual product models that are Y2K compliant.
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\9\ The National Patient Safety Partnership is a coalition of
public and private health care providers, including VA, the American
Medical Association (AMA), the American Hospital Association (AHA), the
American Nurses Association, and the Joint Commission on Accreditation
of Healthcare Organizations.
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fda is now considering reviewing manufacturers' certifications
Last September, we expressed concern that FDA relied on
manufacturers alone to validate, test, and certify that their medical
devices were Y2K compliant.<SUP>10</SUP> Further, we said, since FDA
did not require manufacturers to submit test results certifying
compliance, the agency lacked assurance that manufacturers have
adequately addressed the Y2K problem for noncompliant devices.
Accordingly, we recommended that HHS and VA take prudent steps to
review manufacturers' compliance test results for devices previously
determined to be noncompliant but now deemed by manufacturers to be
compliant, or devices for which concerns about compliance remain. We
also recommended that HHS and VA determine what legislative,
regulatory, or other changes were necessary to obtain assurances that
the manufacturers' devices were compliant, including the need to
perform independent verification and validation (IV&V) of the
manufacturers' certifications.
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\10\ Year 2000 Computing Crisis: Compliance Status of Many
Biomedical Equipment Items Still Unknown (GAO/AIMD-98-240, September
18, 1998).
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In response to our report, HHS stated that it did not concur with
our recommendation to review test results supporting medical device
equipment manufacturers' compliance certifications. It reasoned that
submission of appropriate certifications was sufficient, further
stating that it did not have the resources to undertake such reviews.
However, we were not aware of HHS' requesting resources from the
Congress for this purpose.<SUP>11</SUP> In February 1999, FDA's Special
Assistant to the Director of the Office of Science and Technology, part
of the Center for Devices and Radiological Health, likewise said that
FDA saw no need to question manufacturers' certifications. VA stated
that it had no legislative or regulatory authority to implement the
recommendation to review manufacturers' test results.
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\11\ Year 2000 Computing Crisis: Readiness of Medicare and the
Health Care Sector (GAO/T-AIMD-99-160, April 27, 1999).
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In contrast to FDA's and VHA's positions, several hospitals in the
private sector said that testing of biomedical equipment is necessary
to prove that they have exercised due diligence in the protection of
patient health and safety. Officials at three hospitals told us that
their biomedical engineers established their own test programs for
biomedical equipment and, in many cases, contacted manufacturers for
their test protocols. Several of these engineers informed us that their
testing identified some noncompliant equipment that the manufacturers
had previously certified as compliant. According to these engineers, to
date, the equipment found to be noncompliant all had display problems
and was not critical care/life support equipment. Equipment found to be
incorrectly certified as compliant included a cardiac catheterization
unit, a pulse oxymeter, medical imaging equipment, and ultrasound
equipment.
According to FDA, VHA, and the Emergency Care Research
Institute,<SUP>12</SUP> manufacturers are best qualified to analyze
embedded systems or software to determine Y2K compliance. They further
believe that manufacturers are the ones with full access to all design
and operating parameters contained in the internal software or embedded
chips in the equipment. VHA believes that such testing can potentially
cause irreparable damage to expensive health care equipment, causing it
to lock up or otherwise cease functioning. Further, a number of
manufacturers have recommended that users not test for these same
reasons.
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\12\ An international, nonprofit health services research agency.
This organization believes that superficial testing of biomedical
equipment by users may provide false assurances, as well as create
legal liability exposure for health care institutions.
---------------------------------------------------------------------------
We continue to believe that organizations such as FDA can provide
medical device users with a greater level of confidence that their
equipment is Y2K compliant through independent reviews of
manufacturers' compliance test results. The question of whether to
independently verify and validate biomedical equipment that
manufacturers have certified as compliant is one that must be addressed
jointly by medical facilities' clinical staff, biomedical engineers,
and corporate management. The overriding criterion should be ensuring
patient health and safety.
We recently met with HHS' Chief Information Officer and FDA's
Associate Commissioner for Policy Coordination to discuss options for
FDA to obtain and review test results supporting manufacturers' Y2K
compliance certifications. FDA said that it is now thinking about
reviewing manufacturers' IV&V reports that support compliance
certification. FDA also informed us last week that it is developing a
list of critical care/life support biomedical equipment. It plans to
complete this list by June 1, and use it to identify manufacturers of
such equipment who have not yet responded to its requests for
compliance information. In addition, an FDA official stated that the
list would be used in considering options for reviewing manufacturers'
test results supporting compliance certifications.
information on biomedical equipment compliance of health care providers
incomplete
While information is available on the Y2K compliance status of
biomedical equipment through the FDA clearinghouse and other sources,
it is not clear at this time how extensively health care providers are
using this information to determine their Y2K readiness. According to
FDA, it has taken steps to make users aware of the clearinghouse. For
example, FDA has published articles in professional trade journals and
participated in conferences aimed at health care facilities.
FDA also informed us that the Federal Y2K Biomedical Equipment
Clearinghouse had received about 101,000 inquiries between May 1998 and
January 1999. However, according to FDA, it is not possible to
determine the source of the inquiries.
To determine whether health care providers were using the FDA
clearinghouse to assess the Y2K compliance status of their biomedical
equipment, we reviewed readiness surveys sent to providers by several
federal agencies and professional health care
associations.<SUP>13</SUP> Except for the AMA's survey, none referred
to the FDA clearinghouse. Eleven percent of the respondents to the AMA
survey indicated they were aware of the FDA clearinghouse.
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\13\ These include HHS' Office of the Inspector General, the AHA,
and AMA.
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In addition, the Y2K readiness status of biomedical equipment at
health care providers is not known because a significant number of
providers did not respond to the surveys. As shown in table 1, the
response rates to a survey from the HHS Office of the Inspector General
to urban hospitals, nursing facilities, home health agencies, and
physicians were all less than 50 percent. The response rates to surveys
from the AHA and the AMA on this subject were even less, at 29 and 7.5
percent, respectively. Lastly, the response rate to a survey from the
American Health Care Association (AHCA) <SUP>14</SUP> was very
disappointing, at less than 3 percent.
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\14\ This is a federation of 50 state health organizations that
represent nearly 12,000 nonprofit and for-profit assisted living,
nursing facility, long-term care, and sub-acute care providers.
Table 1: Survey Results of Y2K Readiness of Biomedical Equipment
----------------------------------------------------------------------------------------------------------------
Percentage Percentage
Number Number of Responding Responding
Entity Performing Survey/Group Surveyed Surveyed Responses Currently Not
Compliant Applicable
----------------------------------------------------------------------------------------------------------------
HHS Office of the Inspector General \1\ (December 1998)
HOSPITALS
Rural..................................................... 500 281 31 3
Urban..................................................... 500 208 23 4
NURSING FACILITIES
Rural..................................................... 500 221 21 31
Urban..................................................... 500 191 21 27
HOME HEALTH AGENCIES
Rural..................................................... 500 136 26 41
Urban..................................................... 500 133 21 39
PHYSICIANS
Rural..................................................... 500 124 30 36
Urban..................................................... 500 95 20 52
American Hospital Association (AHA) (February 1999)......... 2,000 583 6 n/a
American Medical Association (AMA) (February 1999).......... 7,000 522 \2\ n/a
American Health Care Association (AHCA) \1\ (March 1999).... 12,000 342 24 28
----------------------------------------------------------------------------------------------------------------
\1\ The survey instructions directed respondents to mark N/A if a question did not apply.
\2\ According to the survey results, 65 percent of responding physicians rent or lease biomedical equipment that
will be affected by Y2K; 41 percent of them were confident that their vendors have prepared the equipment for
Y2K. Data were not provided on the remaining 35 percent of responding physicians.
Source: Organizations listed. We did not independently verify this information.
The survey results also indicated that much work remains in
renovating, testing, and implementing compliant biomedical equipment.
Table 1 shows that less than one third of the hospitals responding to
HHS' Office of the Inspector General stated that their biomedical
equipment was currently compliant, and only 6 percent of the hospitals
responding to the AHA survey stated that their biomedical equipment was
currently compliant. At the same time, more than one third of the home
health agencies and physicians responding to HHS' Office of the
Inspector General stated that the survey question on biomedical
equipment compliance did not apply to them.
In summary, while compliance status information is available for
biomedical equipment through the FDA clearinghouse, FDA has not yet
reviewed test results supporting manufacturers' certifications. FDA has
now begun to think about obtaining and reviewing IV&V reports that
support manufacturer compliance certifications. Such reviews would
provide the American public with a higher level of confidence that
medical devices will work as intended. However, because a significant
number of health care providers are not responding to Y2K surveys sent
by federal agencies and professional associations, the public lacks
information on the readiness of providers. Such information would help
alleviate public concerns about the Y2K readiness of health care
providers and the biomedical equipment they use in patient care.
Messrs. Chairmen, this concludes my statement. I would be pleased
to respond to any questions that you or other members of the
Subcommittees may have at this time.
Mr. Bilirakis. Thank you, Mr. Willemssen.
I have a couple of generic questions, but before I go into
that, I would like to ask the FDA if FDA is concerned, was
concerned, will be concerned about the safety of the medical
device to operate properly after January 1?
Do you feel, Mr. Hubbard, that the agency presently has
adequate legal authority to pull a product from the market and
take steps to ensure that the patients will not be at risk, or
will it require something from the Congress to be helpful in
that regard?
Mr. Hubbard. Well, certainly, we have written regulations
based on the statutory authority we have been given, Mr.
Chairman, to do that. If we determine that a medical device has
not been properly made compliant, and could fail, and could
cause patient harm, yes, we could order that----
Mr. Bilirakis. You do have that authority now, you feel?
Mr. Hubbard. Yes, sir, we believe we do.
Mr. Bilirakis. You won't need any help from the Congress in
that regard, any----
Mr. Hubbard. On that particular issue, I don't believe so.
Mr. Bilirakis. Are there other issues, on that particular
issue, but are there other issues involving this where you feel
that you need more legislative authority in order to be able to
do your job better?
Mr. Hubbard. I think funding has really been the issue, to
some extent, because the program that is doing this, Dr.
Shope's program, and the other folks, they are working very
hard, as you know, to get new medical devices on the market
because we are a gateway to this new technology. It is very
important and we are putting a huge amount of effort into
getting all these new products on the market and to take those
people away to do Y2K has been a stressful situation. But we
have been seeking additional money through the appropriations
process, and some has been coming forward.
Mr. Bilirakis. Thank you. Mr. Hubbard.
Dr. Shope, based on your experiences at FDA on this issue,
are you confident that the medical technology industry will be
ready on January 1?
Mr. Hubbard. I think we are, Mr. Chairman. I would ask Dr.
Shope to elaborate on that, if I may.
Mr. Bilirakis. Doctor?
Mr. Shope. Yes, sir. I think from my reading of the
information we have received in our data base and discussions
with manufacturers, and knowing our regulatory process, that
manufacturers are taking the necessary steps to evaluate and
assess their products, to provide information to customers
about the status of those products, and the steps to remediate
products, the upgrades, or the fixes that the manufacturer can
make available for those products.
So, I am rather sanguine about the situation with regard to
the manufacturers' actions. I think the question, if there is
one, is the extent to which hospitals, who own this equipment,
and use it, are taking advantage of the information and taking
the necessary steps to ensure that the products they have in
their inventory have been checked, have been verified as
having----
Mr. Bilirakis. All right, that is certainly a significant
question, I agree with you, but are we taking steps to be sure
that that is taking place on a timely basis, in the hospitals?
Mr. Shope. Certainly, FDA has taken as many steps as we can
to inform the hospitals about this issue, working with the
American Hospitals Association, the American Medical
Association, very active participants in our healthcare sector
working group under Mr. Koskinen's Y2K Conversion Council out
of the White House. So there is a lot of communication going on
there.
FDA took steps such as publishing in the Journal of the
American Medical Association, mailings of our FDA medical
bulletin, and other kinds of trade press, and other types of
announcements, to make people aware of this issue.
Controlling hospitals is a little bit out of FDA's purview.
Typically, we are dealing with the manufacturers and the
manufacturers' responsibilities to provide good products, and
get those into the hands of the users.
So, I think that this is an issue that we at FDA have not
seen as our prime role, as far as actually ensuring that
hospitals are doing this.
Mr. Bilirakis. Who has that prime role?
Mr. Shope. Well, I think that it is the responsibility of
each hospital to make sure that their patients are treated with
equipment that is going to work and do the right job.
Mr. Bilirakis. Let me go to Mr. Willemssen. Mr. Willemssen,
of course, you and Mr. Hubbard both testified to the fact that
the GAO has made certain recommendations to them. Taking all
that into consideration, do you agree with the positive answers
that we have received from the FDA to my question?
Mr. Willemssen. As of today, I am more optimistic than I
would have been even at the hearing that you held a month ago.
However, there is still a great deal of work remaining. What I
heard in the oral statement today was very reassuring, that FDA
intends, for those critical-care and life-support items, to get
additional information, making sure they do work as intended.
I will also point out that, if you look at the kind of
response rate that FDA has gotten compared to where it was less
than a year ago, that has gone up tremendously, and they should
be given credit for this. There still are a couple hundred
manufacturers outstanding who have not yet responded, but this
is a tremendously better rate than it was. So, bottom line, I
am more optimistic, but there is a lot left to do, and
relatively little time to do it.
Mr. Bilirakis. So, what you are saying is that we are in
danger of not being ready, as far as GAO is concerned, on
January 1?
Mr. Willemssen. I think what is critical right now is that
FDA follow through on some of the steps that they have
mentioned here today, and very importantly, to publicize the
results of those steps, and make it clear to the public, what
we know and what we don't know. As we move closer to the turn
of the century and to the extent that we can, increasing the
percentage of what we do know will go a long way to reducing
any potential panic that could result.
Mr. Bilirakis. With the indulgence of the subcommittee, the
question of whether the hospitals are ready, that Dr. Shope
mentioned, I mean that is a very significant question, and
certainly at least the patients of those hospitals ought to
know whether they are going to be ready, God knows. But, do you
have any suggestions as to how that can be done, what can be
done there?
Mr. Willemssen. I would concur with you, the available data
are not reassuring on the extent to which hospitals appear, or
are saying they are checking this. So, I think that FDA can
step-up its publicity campaign a few more degrees. For example,
it could make sure this is a major agenda item--and you might
want to address this with the second panel--at some of the
major conventions, health-related conventions.
Also, I think, that when FDA plans to come out on June 1--I
believe that is the date they are listing the critical-care and
life-support items they will be checking for Y2K--it should be
publicizing this list and letting the public know, ``We are
going to take an extra step for these kinds of items, and give
you added assurance of what the Y2K issues are, and what we
have found.''
So, I think, again, that the FDA has done some good things
in putting the word out. They can do more, though, especially
as we get closer to the date.
Mr. Bilirakis. Well, you know, I can't get over how we have
gotten into this fix. We have put people on the moon; we have
done so many great things technologically, and we all knew that
the year 2000 was coming up. I am certainly not computer
literate, I am ashamed to say, but most people are, certainly
the experts and the agencies, departments, and with the various
companies out there in the industry are. They have all known
this was coming up, and yet we are running into this problem.
If we have got to put ourselves into the shoes of that patient
out there who reads about this, and maybe unduly so, is being
really shook up--well, all right, Mr. Brown.
Mr. Brown. Mr. Chairman, thank you. I would first like to
ask unanimous consent to keep the record open for 3 days, say,
for questions to be submitted.
Mr. Bilirakis. By all means and, of course, we always ask
the witnesses if they are willing to receive additional
questions, and are willing to respond to them. By all means,
without objection.
Mr. Brown. Mr. Willemssen, you have made the argument
several times that FDA should require manufacturers to submit
test results certifying compliance because, unless they do so,
the agency really has no assurance that those manufacturers
have adequately addressed the Y2K problem. Why should the FDA
do that?
Mr. Willemssen. We recommended this, for a subset of
biomedical equipment items, those considered to be in the
critical-care and life-support areas. So, we don't recommend
that for all items, but just a small subset where the impact of
a Y2K failure would have resulting effects on patient safety.
We think this additional step is necessary to provide the
public with added assurance that these items are going to work
as anticipated.
As I mentioned in my testimony, we have identified some
hospitals who told us that in some cases their own testing has
identified items thought to be compliant that were not
compliant. Now, in those cases, none of those, to date, that we
are aware of have had a safety impact. They have primarily been
display problems. But I think that because of the criticality
of the issue, we think for that subset of items, that the
additional step is warranted.
Mr. Brown. What form would the data take? Would it be in
great detail, in binders, and hundreds of pages or would it be
a study or sort of outline of the methodology and then a
concise report of the results?
Mr. Willemssen. It would not entail, or should not entail,
any additional work on the part of the manufacturers because
they should already have those results available in order for
them to come to a conclusion that the item, is indeed,
compliant. I would say, the process would work along the lines
of FDA asking to look at the information to see if there is
support behind the determination that the item was compliant.
Mr. Brown. What kind of resources would it take for FDA to
do that? Have you conducted any analysis to determine if the
FDA even has the resources to implement your recommendation,
even if, in fact, it agreed with it?
Mr. Willemssen. In talking with FDA on this issue, we
suggested that they not just look internally, but they also
look at other available resources, both private and public. You
may or may not know, one of the leaders in this area has been
the Department of Veterans Affairs, who actually was on board
first in putting together quite a bit of information on
biomedical equipment items. FDA then came on board with VA, but
VA also has some expertise in this area. So, I think in looking
at the resource question, FDA needs to go outside of its own
boundaries and look at what available expertise there is.
Mr. Brown. Dr. Shope or Mr. Hubbard, do you think that FDA
has the technical expertise internally and in other parts of
the government into which it can reach to do that?
Mr. Hubbard. Well, not in any great numbers, Mr. Brown. We
have a small staff of physicists and other biomedical engineers
in Mr. Shope's office. It is a handful of people. They probably
do have the technical expertise. Beyond that, I don't think so,
because the kinds of data that you would get from a company,
you know, probably large stacks of verification data and test
data results would require someone with some knowledge of the
product and the way that the software was designed and the way
it operates. In the case of a fix of a non-compliant product,
how that was done, and how that was tested and verified to be
sure.
There may be the technical talent out in the country that
could be contracted with to do that, of course, understand that
the numbers could be perfectly enormous at a 100,000 different
medical devices and 1,700 different categories. But only around
2,000 perhaps, have some date issue. We think, perhaps, in
range of 300 to 600 actually are of the type, so called,
critical care devices that Mr. Willemssen is talking about that
might be in that category. So the number that would be most
concerned is a much more manageable number. We believe that it
would be possible to contract with professionals in the IT
area, and perhaps, engineers to go to firms to look at this
data. It would cost some millions of dollars, however, to do
that. And I think there is a question as to whether or not the
taxpayers' funds should be spent to do that sort of thing. That
is why we are proposing our sampling proposal, which could be
done much more cheaply, to build additional confidence, and
then determine if, in fact, we need to do more than that.
Mr. Brown. Mr. Willemssen, you note in your testimony, FDA
saw no need to question manufacturers certifications regarding
Y2K compliance status. Is GAO taking the position that FDA
should question the reliability or truthfulness of
manufacturers certificates?
Mr. Willemssen. What we are saying is for those critical
care and life support items, added assurance is needed to the
American public to make sure that they work as intended. Some
hospitals have told us that their own testing has identified
some equipment that was thought to be compliant that wasn't. It
is not to say that organizations are not to be trusted, but
where the criticality is high, an extra pair of eyes could be
very useful.
Mr. Brown. Mr. Chairman, could I ask for 60 additional
seconds?
[Mr. Upton nods head to indicate yes.]
Mr. Brown. Thank you.
So, Mr. Willemssen, if the FDA does certify that a
manufacturer has undergone Y2K compliance testing, in taking
into play, into consideration, the comments of Mr. Hubbard
about a possible lack of resources, including technical
expertise in the agency, does the Government run the risk of
becoming liable if a serious Y2K problem develops with
equipment that the FDA reviewed?
Mr. Willemssen. I think there can be no absolute guarantee
that equipment will work as intended, even with additional
checks being made. What you have done is closed the gap on the
risk and made it more manageable for those especially critical
items.
Mr. Brown. You have closed the gap on the risk that have
you, in fact, shifted some of the responsibility then to a
Government agency from the private sector, who ultimately
should, in fact, be responsible for compliance and for success.
Mr. Willemssen. Well, under this recommendation, FDA would
not be independently testing items themselves. They again,
would be relying on the work that has been done by the
manufacturers.
Mr. Brown. But FDA technical experts would review the
methodology, look at the results, and ultimately have to make *
* *, and put a stamp of approval on it. Correct?
Mr. Willemssen. Under that process, it ultimately come to
some judgment as to the risk involved, and whether all
appropriate good manufacturing practices have been followed in
assuring themselves that this a Y2K compliant item.
Mr. Brown. So, are they shifting some of the reliability on
the FDA? This recommendation?
Mr. Willemssen. I will, in part, defer to the record on
that because I am not an attorney by training. I would defer to
Dr. Shope and Mr. Hubbard, but we did not, on the face, see it
in that way.
Mr. Brown. Could Dr. Shope answer the question and then I
will yield back? Dr. Shope.
Mr. Shope. I just wanted to make a comment on the issue of
the testing, or not so much testing, but the verification of
manufacturers activities. What we are talking about here is
really exactly the same kind of activities that FDA undertakes
on a routine basis in our inspection of manufacturers quality
systems. It is the quality system that a manufacturer has in
place that gives us the assurance that they are developing,
designing, producing, evaluating medical devices in a way that
gives us assurance about their safety and effectiveness. And
what we are talking about here is focusing some additional
effort, if we were to do it, on those changes related to Y2K.
We rely on this quality system for the initial development of
medical devices. We rely on it when we clear them for pre-
market and we rely on them for any other kinds of changes.
Medical devices frequently are found to have problems;
those problems get corrected. Particularly with software
control products, new features are added, those are done under
the quality system and the design control process. All of that
is done by the manufacturer, using the quality system that they
have in place.
I think that the issue here is that whether something
additional is needed for dealing with these Y2K upgrades. I
think, strongly, that our regulatory system that we have, with
the quality systems that manufacturers use, and that FDA
exercises oversight to verify that are in place and are being
used gives us a high level of confidence that these activities
are being conducted and they do give us this kind of assurance.
The question is, do we need to do something more and additional
and special just for the Y2K issues?
Mr. Brown. Thank you, I thank the chairman for his
indulgence.
Mr. Upton. Thank you.
Mr. Hubbard, I was very interested in seeing that there
were, I guess, 232 companies that did not respond to the
inquiry from FDA. What is happening to these companies? What is
the level of your concern?
Mr. Hubbard. All right, that is a subset of the firms that
we believe might make products that are date dependant, as
opposed to the large universal products that have no computer
issue involved in them. We are continuing to pursue those
companies. We have a contractor of calling and trying to
identify those companies. By and large, we believe that they
are companies that are, perhaps, foreign companies that have
gone out of business or we can't find, otherwise, and perhaps,
aren't marketing a product in this country anymore. Even though
that is our suspicion, we are trying to confirm that, that is
in fact true, and that none of those 232 are marketing any
products. I believe, Tom, that it is actually 199 now, it is
down to 199, we have found a few more in the last 3 days.
Mr. Upton. Well, that is good to hear. In your statement,
your written statement, you didn't talk about the statistical
sampling that you have now decided to embark on that you talked
about in your verbal statement. As I recall, you said something
like, you are going to survey about 60 firms, is that right?
Mr. Hubbard. Our belief is, we have asked various experts
at the device program to look at the sorts of devices that the
GAO has identified, as perhaps, what they call critical care
devices. But devices that have a potentially high risk to
patients if they were to fail due to a date dependency. We
believe there is somewhere over 300 manufacturers of such
devices. So, the concept would be to develop a representative
sample of that 300-plus device manufacturers and then go out
and audit that sample. And 60 sounded like, we are looking
around 60 as being a good representative sample to feel that we
have covered the range of these kinds of products.
Mr. Upton. Is there a reason why you might have waited so
long, the end of May, to sort of begin to do that?
Mr. Hubbard. I think, as we have said earlier, Mr. Upton,
we do have a fairly high confidence level that there is not a
problem here with these products. Every time that there has
been an allegation that a device has failed, we have followed
up on it, stringently, and we have not been able to find the
sorts of life-threatening concerns that exists. But that is not
to say that, as Dr. Shope just said, that perhaps we can do
more. The GAO is saying, take it to one more level and go into
the firms and look at their data and quiz them more and develop
yet an additional layer of confidence for the hospitals and the
public and the Congress that, in fact, things are okay. We have
a fairly high degree of confidence now that these devices have
been attended to.
Mr. Upton. Mr. Willemssen, have GAO's efforts primarily
been focused on the manufacturing end and the FDA end? Have you
at all looked at the degree of communication between the
hospitals and their communication, their networking among
themselves?
Mr. Willemssen. We have to some degree, but most of our
audit effort in this area has been focused primarily at what
FDA actions have been taken and less so in the other areas.
Mr. Upton. Do you think that that would be a wise approach,
to talk to some of the hospitals to see how they are fairing?
Mr. Willemssen. Yes. One thing, because of our concern on
what the data was showing about the apparent lack of use by
some of the healthcare providers of the FDA data base, we were
pondering whether some independent organizations do spot checks
of major healthcare providers to ask them, ``Have you checked
the data base?'', and ``Oh, by the way, did you know that these
particular items are considered non-compliant? Do you have any
of these items in your inventory? You should probably go
check.'' We don't have a high degree of confidence as to
whether those kind of activities have been done or not. They
may, in fact, have been done to large degree, but the data
doesn't show this. And that is the reason for our concern.
Mr. Upton. Thank you. Mr. Bryant.
Mr. Bryant. Thank you, Mr. Chairman. I have just a question
for, I guess, the FDA, Mr. Hubbard. I missed your testimony, I
had to run to another committee meeting. So, you may have
talked about this, and this may be a real basic question, a
simple question, if you will. Regarding the FDA approval
process for medical devices, has that been a standard, is that
a standard now for approval of a medical device, that it be Y2K
compliant?
Mr. Hubbard. Well, it certainly is now. We have been
identifying it, as you know, we have review staff, physicians
and others that review new medical devices for their safety and
efficacy. And, of course, a different process for changes in
approved devices that are already on the market. Certainly, our
reviewers are now making that one of the things that they look
at. Obviously, the companies have great incentive to make sure
that that is not a problem, but as an additional check, our
reviewers are asking that question and making sure that there
is not a date dependency issue with new devices going on the
market, now.
Mr. Bryant. How long has that been a standard? I understand
that your testimony is that it is a standard of FDA before it
approves a medical device, that it be Y2K compliant. How long
has it been the standard?
Mr. Shope. If I might answer that. We focused on this issue
early in 1996, and I think we got a general agreement in our
Office of Device Evaluation that, for those types of devices
where this date issue could be a critical aspect to their
functionality, those pre-market review staff were sensitized to
this issue in late 1996, early 1997. We have to note, however,
that there are two routes to market. One is a new device, the
pre-market approval process, which gets a high level of
scrutiny. The second is substantial equivalence. Back at the
end of the 1997/98 timeframe, we actually had a few products
come to market that had been under development through the
510(k) process, that the manufacturer said, ``I realize this
product is not Y2K compliant today, but by the time it is an
issue for this particular product, we will have a software
upgrade.'' So, based on the issue of substantial equivalence
determination, those products were allowed to go to the market.
But, the manufacturer had the understanding that he needed the
software upgrade in the next couple of years, and to get that
into the hands of the users. And that those products will be
misbranded and adulterated as of year 2000, if that hadn't been
remediated.
Mr. Bryant. How do we catch and correct those instances
now?
Mr. Shope. Those are, again, products----
Mr. Bryant. The manufacturer?
Mr. Shope. The manufacturer knows about it already. He has
communicated to the users of those products, if they are still
out there, and those early software versions should be listed
in our website as a non-compliant version that the hospital
needs to check to make sure that they have gotten the upgrade.
So I think the information about that is there. Again, a big
part of the responsibility here is on the healthcare users to
compare what they have to what has been demonstrated to have
issues, then to take the remediation steps that are necessary.
Mr. Bryant. Thank you. I will yield the balance of my time
to my colleague from Iowa.
Mr. Ganske. Thank you.
Mr. Willemssen, I want to be sure that I heard you
correctly. I think you quoted some study that said only 6
percent of hospitals say that their equipment is Y2K. Was that
correct?
Mr. Willemssen. I believe so, yes, sir.
Mr. Ganske. Six percent?
Mr. Willemssen. Yes, the table on page 14 of our statement
reflects that 6 percent statement.
Mr. Ganske. Okay. Well, then, coupled with your other
statement that said that you know of some hospitals that are
doing their own testing of equipment where they say the
manufacturers say they are compliant but then when the
hospitals do their testing, they aren't, can you give me some
examples of what type of equipment they have checked?
Mr. Willemssen. Yes. There were equipment such as a cardiac
catheterization unit, a pulse oximeter, medical imaging
equipment, and ultrasound equipment. Now, what the hospitals
that we talked to said, that the issues they found were display
problems that didn't appear to have immediate health impacts.
Mr. Ganske. Except that if you have a pulse oximeter and it
is not reporting correctly, that can be a pretty serious
problem.
Mr. Willemssen. Yes.
Mr. Ganske. Like if you had a pulse oximeter on a patient
during anesthesia and it is incorrectly reporting. Now, Dr.
Shope, you are shaking your head no?
Mr. Shope. I would just say that most of these kinds of
issues have to do with recording a record of what the device
has done; and, typically, do not impact the actual
functionality of the device. The pulse oximeter, I don't know
the specifics of this one, but my information would be that
that pulse oximeter would work as intended; it will give the
display as intended. What might be the problem here is either
the display on its face or a readout showing the day's date and
time or a record of what was occurring and the date and times
associated with that record of what the device did. Typically
very few medical devices have a date dependency in their
functionality. Many of the problems that we have that are
listed as non-compliant problems are problems associated with
keeping a record of what the device did, or the way in which
that date is displayed.
Mr. Ganske. But, some do have time-dependent functions,
such as ventilators, where you set the rates and things like
that, or dialysis machines and things like that. Is it possible
that those could be affected by chips as well?
Mr. Shope. It is not out of the realm of possibility.
However, most medical devices are kept as simple as possible,
and therefore, I can't think of very many of these issues where
the day of the week or the day of the month, that kind of date
record is relevant to the operation of the device. What is
relevant perhaps is time intervals, and there are other ways of
keeping track of that than having to record date and time
information.
So, we think manufacturers, the vast majority of these
approaches, keep it as simple as possible; use only the timing
that is necessary; don't depend on date, month, year kind of
information when that is not necessary. So, it is not out of
the realm of possibility that a system could be so designed.
One of the very large issues is many medical devices are
either controlled by, or provide data to, or through, a PC-type
system. So if that associated PC can't keep good records of the
date and time, any recording that it does, files that are
stored, dates associated with that information, gets corrupted
because of the Y2K problem. It really doesn't impact the
functionality of the device. The service that you want from
that device gets delivered. It is the recordkeeping associated
with what happened that may not be as you would desired.
Mr. Bryant. Mr. Chairman, the time is out. I will come
back. I will try to be back for additional questions.
Mr. Upton. Thank you. Ms. McCarthy.
Ms. McCarthy. Thank you, Mr. Chairman. Dr. Shope, I note in
a article from Healthcare Today last November/December, Joseph
Jorgen's piece that states, ``Since Y2K non-compliant products
function appropriately at this time, the Center for Devices and
Radiological Health will clear and approve Y2K non-compliant
devices. However, manufacturers will be informed that if these
devices are not upgraded, they will be considered adulterated
as of January 1, 2000.''
You can recall products. Are there any products that you
intend to recall because of Y2K? If, for example, some
manufacturers face this dilemma described in this article in
their projects, or products under investigation, you know,
don't comply, at what point should healthcare providers go into
contingency plans? And would you expand upon what those should
be?
Mr. Shope. We have no plans right now, or no products
identified that would merit a recall as far as our authorities
go, because, by and large, all of the products that have
problems, those problems have been identified and the
manufacturer is providing a route to upgrading or correction of
that problem. It is only if there were a product which
presented a very serious risk to injury and there was no action
being taken by the manufacturer, there was no upgrade
available, then our regulatory authority to do a recall would
come into play.
I think the contingency for hospitals, or for healthcare
facilities, is not so much a contingency, but what they need to
be doing now. Which is doing their inventory, assessing their
products, determining which of the inventory might be
susceptible to a problem, availing themselves of the solution
that the manufacturer has provided for that problem, and
remediating their inventory. If there are products for which
they cannot find the manufacturer because there are a few
manufacturers that do go out of business--I don't think this is
a very large issue--but should they not be able to find the
original manufacturer, and they can't obtain any technical
information about that product, then the hospital has to make a
decision based on what that product is and the way it could
impact patient care as to whether they can somehow evaluate it
themselves, have a third party evaluate it for them, or take it
out of service. Probably the best thing is to take it out of
service and find a replacement for that device.
Ms. McCarthy. But, you are approving Y2K non-compliant
devices now, correct, or is this article factually incorrect?
Mr. Shope. Well, I think at the time that the article was
written, back in November, we were still anticipating that we
could get 510(k) submissions which would come in and say, I
have a problem, I want to get clearance for the software as I
have designed it now, but it has got to have an upgrade to be
Y2K compliant 1\1/2\ years from now, or 2 years from now. We
had no mechanism to deny access to market for that kind of
product.
Ms. McCarthy. But you do have the power of recall. So if
you find, having taken that step that was appropriate, that
recall is needed, because the next step, per your request, was
not met, will you take action of recall?
Mr. Shope. Oh, certainly, if we find any product where
there is a potential risk to health that would rise to the
threshold that is contemplated for the recall authority, we
would certainly vigorously pursue that issue.
Ms. McCarthy. Well, on a second point that you raised to my
question on the hospitals taking necessary steps, Health
Midwest, which is a very huge presence in my congressional
district in Kansas City, expects to spend about $10 million to
check the 21,000 biomedical devices that they have. This was in
a big piece over the weekend in the Kansas City Star. How are
the smaller hospitals going to pay for these activities, my
teaching hospitals, Children's Mercy and others?
Mr. Shope. If they are going to attempt to test all of
their inventory, they have a rather tremendous undertaking.
However, I think there is real question about whether hospitals
need to do this kind of testing. There are a number of groups
that have weighed in on this issue, FDA has not taken an
official position, but I think our knowledge of the medical
device industry and the medical device designs would say that
the manufacturers is really the only one in a good position for
a complex medical device to do an adequate evaluation and
testing of that product. So, my advice to a hospital would be
to rely on the information from the manufacturers about the
compliant status of the device and I would question a massive
undertaking to test medical devices on the part of hospitals.
Ms. McCarthy. With all due respect, your organization
having approved non-compliant Y2K products, appropriately at
the time, and then relying on the companies to come forward and
assure hospitals, indeed, that all of that has been addressed,
what does that do for the risk of the hospital if that is
somehow factually wrong? I can see why hospitals want to do
their own testing. They have a stake in this, too. They will be
responsible to the patients that they serve. Do you see the
sort of argument going round and round.
Mr. Shope. Right, and it is the same kind of argument that
would apply, I think, in a much bigger issue, which are the
products that were approved without knowing they were non-
compliant. Now, we have many of those that are, in fact, non-
compliant, and the manufacturers are developing upgrades. So,
the situation, I don't see much difference between the
situation there. The issue is the manufacturers have assessed
their products; they know which ones have problems; they are
providing solutions for those. If it comes to our attention
that there is a product that is out there and it is a type of
product that could present such a risk to a patient and no
action is being taken, that is the kind that we would be able
to exercise our recall authority. I have to say that, there are
very few products that I can contemplate that would rise to
that level of risk-to-patients that the manufacturers haven't
addressed and provided a fix for.
Ms. McCarthy. I see that I have gone beyond my time, Mr.
Chairman, and I apologize, but I wanted to pursue this issue,
and I thank you.
Mr. Upton. Mr. Burr.
Mr. Burr. Dr. Shope, let me just say that your answer to
Dr. Ganske was the most reassuring thing that I have heard in
this hearing so far, when you answered Dr. Ganske earlier. Let
me stick with you for just a second. Do I take from your answer
to Ms. McCarthy that, from a standpoint of a rural versus
urban, we shouldn't have a concern that rural America is more
at risk than urban America?
Mr. Shope. No, I wouldn't conclude that, because I think
one could anticipate the amount of resources being available to
the smaller, rural facilities and the kinds of expertise
available to them to simply do the inventory, to do the
evaluation, to do the followup, and perhaps, if there are items
that need to be replaced, to make those replacements. I think
the facilities have work to do.
Mr. Burr. We are still very reliant on the facilities to
make determinations as well?
Mr. Shope. Yes.
Mr. Burr. Let me ask you, Mr. Hubbard, 16,000 manufacturers
originally contacted; we heard, from 4,100, you said that there
are roughly 200 that you are chasing. That is 4,400. Clarify
for me, if you will, where the other 12,000 are. Are they
hospitals, doctors, what?
Mr. Hubbard. Right, the numbers can get confusing. Our
initial letter went to 16,000. There are about 13,500 device
manufacturers; we added in, at the request of the White House,
2,500 instrument manufacturers, so that the larger world of
biomedical products would be covered, even though some of those
are not devices that FDA regulates. Then, I think the important
number is that about 2,000 are manufacturers of products that
might have a date-dependency issue. Things like tongue
depressors, obviously, aren't a problem, so they are in that
16,000, but they are not a problem. They got a letter, but they
either didn't write back or we don't care if they don't write
back.
Mr. Burr. Do we know all the medical devices that have a
chip or software problem?
Mr. Hubbard. Well, as I said, if you take the 2,000,
roughly, that might have a date-dependency issue, we have heard
from all but about 200 of those. So, it is those 200 that we
haven't heard from we are trying to trace down. As I said
earlier, they seem to be firms that aren't doing business here
any longer, and they are not a problem, but we don't want to
just assume that; we are continuing to try to find them.
Mr. Burr. Based upon what we know today, how many medical
devices have a potential chip or software problem?
Mr. Shope. FDA does not, per se, have a list of all medical
devices by make and model number. What we have are
manufacturers who have gotten an approval for a particular type
of device, one of our classification regulation types. We have
1,700 classifications, different generic types of devices.
Mr. Burr. Wasn't one of the recommendations of GAO that we
track this based upon model serial number as far as the
clearinghouse purposes of listing, so that people would know
the classification?
Mr. Shope. Right, we, in fact, have done that. We have
gone--let me just make the point. We don't have this list of
make and model because manufacturers design many different
models, many different makes. So we don't have that list of
inventory. What we have done, though, is look at the
manufacturers that make the generic types of products that we
think are susceptible to being computerized or having computer
control, or having microprocessor control. It was that activity
that identified the roughly 2,000 manufacturers that we wanted
to focus on because they make the types of products that are
likely to be susceptible, even though we don't know for a fact
that each one of those has computerized their particular
versions. There can be computerized and non-computerized
versions of the same equipment. Our data base doesn't get to
that level of specificity.
So, to address this issue of specific information about
products that could be vulnerable, we have asked the
manufacturers, that same universe of roughly 2,000
manufacturers, to give to us a list by make and model number of
the devices that they have verified do not have a Y2K problem.
And we are in process now of collecting that information.
Mr. Burr. That do not?
Mr. Shope. Do not have a problem. We already had
information on the products that have problems.
Mr. Burr. And there are how many that have a problem?
Mr. Shope. We don't have that exact number. I can tell you
that in our data base we have heard from roughly 310
manufacturers that have described 800 or so products that have
specific problems.
Mr. Burr. So the number is, from the respondents so far,
800-plus?
Mr. Shope. Plus, and the plus is because we have 350
manufacturers that haven't given us the list of problem
products. They have posted it on their website, and we haven't
enumerated those.
Mr. Burr. And what was the deadline that the FDA gave these
manufacturers for reporting this information?
Mr. Shope. This is a voluntary effort, and we didn't give
them a deadline. We asked them, as soon as you have finished
assessing all of your products, because one of the issues here
is that manufacturers with extensive inventory had to have
assessed all their current and previously manufactured products
that might be in use in order to submit this information, and a
conclusive list of any product that could have a problem, and I
think the rate of submissions of that have slowed down
considerably around the first of the year.
In March, we asked some of the manufacturers who hadn't
given us sufficient detail to provide additional detail on the
nature of the problems. So a hospital going to our data base
would see, not just the product as non-compliant, but why it is
non-compliant and how that would affect the functionality of
the product.
Mr. Burr. Does the FDA have any contact with hospitals
relative to this list of 800-plus pieces of equipment that
might or might not have a problem?
Mr. Shope. I am not sure I understand your question.
Mr. Burr. Well, I take it for granted that Mr. Hubbard's
answer earlier that, in the 16,000 people contacted, that did
not include hospitals or doctor's offices----
Mr. Shope. No, that's just manufacturers' devices.
Mr. Burr. My question is, now that we have identified 800-
plus possible devices that might have a date-sensitive or
software-sensitive problem, has there been any correspondence
from the FDA to hospitals saying, ``Here is what we have found
so far.''? Or are we relying on hospitals to go into the
website to look up this information?
Mr. Shope. Right, we are making the website our mechanism
of disseminating this information. I will add that the Health
Care Financing Administration and several mailings to all of
their practitioners and healthcare facilities have emphasized
the need, not just to address their financial systems and their
payment issues, but also their hospital equipment inventories,
and have given the hospitals the reference of how to find the
FDA data base and the kind of information that is there. So,
there has been a lot of notification to hospitals about this
issue.
Mr. Burr. Does HHS look at HCFA as their conduit to
hospitals and rural health clinics and community health centers
and doctors' offices? Is that our line of communication?
Mr. Hubbard. Well, certainly not solely; I think, in fact,
that they have that conduit; that has been very helpful. But,
as we said earlier, we have also tried a number of direct means
through the press, mailings directly to physicians and others,
articles in various professional journals that we know these
people read and other things.
Mr. Burr. Is there a primary part of HHS that is
responsible for hospitals and community health centers and
rural health clinics and doctors' offices?
Mr. Hubbard. Certainly HCFA is in the sense of payments,
and has regular contact with them and knows who they are and
how to reach them. We do not; we do not regulate the practice
of medicine or these facilities.
Mr. Burr. Are we the first one to ask that question?
Mr. Hubbard. I am sure that you are not.
Mr. Burr. I see that my clock has run out, and I hope that
we will be the last ones to ask the question of whose
responsibility it is.
And I will yield back.
Mr. Upton. The gentlemen's time has expired. Dr. Ganske.
Mr. Ganske. Thank you, Mr. Chairman.
Dr. Shope, can you provide us with that list of 800-plus
products?
Mr. Shope. Yes, sir, that is on our website. It can be
downloaded by any citizen that wants it, and we can provide it.
Mr. Ganske. Okay. Please send that directly to my office.
Now, we were having a discussion before where I think you
were basically saying that a lot of this is equipment with the
timer function related to readout data. Congressman Vern
Ehlers, who I respect a lot on his knowledge on these issues,
has pointed out that, for instance, with household appliances--
i.e., let's say thermostats that run off of computer chips that
have timer functions, they don't necessarily have a year on
your readout, but the chips that are in there may be older
chips or chips that are not Y2K compliant. And he has
speculated that there could be problems with the functioning of
the rest of the chip if it is not Y2K compliant, even though
you may not get the readout. Do you have any perspective on
that?
Mr. Shope. I think in our discussions with our design
engineers about this issue, our conclusion is that we would be
very surprised if a medical device designer inserted into a
medical device, particularly a medical device that had any
critical life-supporting, life-sustaining kind of
functionality, that kind of a timing chip or device that was
unnecessary to the design. So, I think this is an issue that
has been speculated a lot about, but I have really no hard
evidence that, in fact, is an issue.
Mr. Ganske. Except for the fact that the hospitals that
have done some of their own testing have shown that some of
those devices that were supposed to be Y2K compliant are not.
Mr. Shope. That's right, and to the ones that I am aware
of, it has not been the kind of problem that you have just
described. It was usually an oversight between a manufacturer
and a parts supplier about a functionality for some accessory
device used with the device, and missing the fact that there
was a minor date issue there that needed to be addressed and
didn't get addressed in the initial assessment.
Mr. Ganske. Dr. Shope, I see that you are with the Center
for Devices and Radiological Health, so I want to go to ask you
a question specifically I think that is from Mr. Willemssen's
testimony on page 4, where he talks about radiation treatment
delivery devices using a radio isotope as a source and that an
error in the calculation in the radiation source strength on
the day therapy is to be delivered could result in a dose that
is either too high or too low. Are you familiar with this
particular device and potential problem?
Mr. Shope. Yes, sir.
Mr. Ganske. Could you describe that in a little bit more
detail?
Mr. Shope. Okay. Radiation treatment planning systems are
basically software programs, or computer programs, and often
they come with a workstation interface that the medical
physicists in the hospital or the radiation therapists in the
hospital use. These are programs that use imaging data that is
acquired, either from something like a computer tomography x-
ray machine or a MRI scanner, where you delineate the patient's
anatomy. You then take that information, import it into the
computer program that plans the radiation treatment, and the
radiation therapist, in consulting with the medical physicist,
develops the plan for the direction of the radiation beams and
the intensity of the beams and the number of them and frequency
with which they will be used to treat a tumor volume and to
spare radiation damage to the surrounding tissues. So, these
are very complex calculational programs.
This kind of therapy is typically delivered, for the most
part, currently, by a device called a linear accelerator. That
is a big machine; you turn on the switch, and it emits
radiation or electrons, and you turn it off and it stops.
There are some older versions of radiation therapy,
however, that don't use an electronic means for the source of
the radiation; they use radioactive isotopes. This is referred
to as teletherapy when it is a cobalt-60 unit, which is a
source of the radiation. You open the shutter, and let the beam
out for the radiation.
Another type of treatment is called brachytherapy, which is
when the isotopic source is either inserted into the patient or
applied directly to the patient. In either of those types of
planning, if you are planning brachytherapy or teletherapy, one
of the calculations that has to be made about the therapy is
what is the strength of that radioactive source on the day you
use it, compared to the day in which it was calibrated
initially, which may be 6 months ago. And so there is a date
calculation involved. Some of the earlier versions of software
that incorporated brachytherapy or teletherapy features for
planning that kind of therapy did, in fact, use two digits to
represent the year. So this calculation of source strength on
the day of use could be an error, if that wasn't corrected.
There were products on the market that did that
incorrectly. The manufacturers have identified those, and have
either said, this is the upgrade, the software fix needed to
address that issue, or this product is so old, there are so
many new features in our current version of product, that we
aren't going to upgrade the old product; we suggest you buy a
new replacement. In fact, the Department of Veterans' Affairs,
I think, had seven of those types of systems that they had to
replace, at no small expense. But they chose to do the
replacement.
Mr. Ganske. Do you know where all of those machines are?
Mr. Shope. No, sir. These are software programs that are
purchased by hospitals.
Mr. Ganske. Right. So you do not know, then, whether the
hospitals that have those software programs have received data
warning them of that?
Mr. Shope. No, sir, we don't have specific knowledge of
that.
Mr. Ganske. So, it is possible, then, that on January 1,
2000 a patient could get an inappropriate calculation?
Mr. Shope. If the hospital has paid no attention to this
issue and ignored all of the information that has been
presented, I have to----
Mr. Ganske. And what would be the consequence of a patient
receiving an overdose?
Mr. Shope. It could be either an overdose or an underdose;
one would be----
Mr. Ganske. Underdose, they don't get treated enough.
Mr. Shope. Complications to the therapy used.
Mr. Ganske. Could a patient die if they get an overdose?
Mr. Shope. It depends on the level of the overdose, sir.
Mr. Ganske. Possible?
Mr. Shope. It is certainly possible.
Mr. Ganske. Thank you.
Mr. Upton. Thank you. We will go to a second round for
those that have additional questions, and I do have one.
You know, when I think about my own purchase habits,
whether it is a gas grill, or certainly an automobile, even an
alarm clock, you get a little warranty card and they ask for
your name and address, and if something is wrong, I suspect
that they come back to you. The fact is that I have had
problems with even seatbelts and that type of thing; I hear
back from the manufacturer, and when I take that car back in to
the facility, it is on record there, so if I happen to forget
that was a cause, then they remind me and they take care of it.
Is there any such, when you talk about the 800 devices that
are, in fact, could be a problem with the date, is there any,
other than checking the website--and I appreciate that, and we
are going to get that information out to my providers in our
State for sure--but is there any way that the hospital would
hear or that the provider would hear directly from the
manufacturer that their product is on that list of 800
products, directly from the manufacturer versus them taking the
initiative?
Mr. Shope. Yes. There has been a tremendous amount of
communication from manufacturers to their purchasers,
particularly for products that the manufacturer has identified
as being non-compliant. We can't say 100 percent that every
manufacturer of every one of those 800 products has mailed a
letter to each one of their purchasers, if they know them. But,
I think manufacturers have a very large interest in
communicating with those purchasers. If it is known that a
purchaser has a product that needs replacement, it certainly
makes a lot of good business sense that the company would want
to be there and be involved in that purchaser's mind about
replacement activity. So, I think the original manufacturer has
lots of incentive to communicate to their purchasers problems
about products they may have in the past purchased. This is a
very common activity.
Mr. Upton. So, to your knowledge, what would you say, 90
percent, a 100 percent of the providers have been contacted if
they are on the list of 800?
Mr. Shope. I couldn't put a number on it, sir. But, I think
it is not uncommon. You might ask the representative from the
manufacturers about this. But, I think the vast majority of
manufacturers do communicate with their customers about these
issues.
Mr. Upton. But, probably not 100 percent?
Mr. Shope. No, sir.
Mr. Upton. Okay. Mr. Brown.
Mr. Brown. Dr. Shope or Mr. Hubbard--Dr. Shope, you
mentioned, in response to a question I believe from Mr. Burr--I
am not sure--that you had some information on which specific
companies have Y2K problems. Talk through that again. I mean,
the overall feeling that I am getting from this hearing is
neither of you, Dr. Shope or Mr. Hubbard, seems real concerned
that there is any significant problem here yet. When I hear
some of your answers to which companies, how many companies
making how many products, have problems, I am a little
concerned. So, run through. Does the FDA have a list of medical
equipment, one, that presently has a Y2K problem; second,
presently has a Y2K problem that might actually be life-
threatening? Tell me what you know about that.
Mr. Shope. We have two kinds of information about products
with problems. We have the information that the manufacturers
have voluntarily provided to us, and that is posted on our
website. That is currently on the order of 900 specific
products.
Mr. Brown. That is some 300 companies, you said?
Mr. Shope. Yes. The second kind of information is
information from roughly 350 companies that are posted on their
own websites. I can't say that I have looked at every one of
those companies, but I have reviewed a large number of that 350
to see what kind of information is there, what kind of products
are being described, what the nature of the problem is. I have
also looked at our own website, probably when the number was
more like 600, instead of 800, and gone through that list and
looked and tried to gather some impressions of the kind of
products that were there, the nature of the problems, and
whether any of those presented a very significant risk.
There are a few products there that one would be concerned
about if the hospital didn't take action. The vast majority of
them are date display or recording in a way that, I think,
would be rather insignificant in terms of patient-immediate
impact. It could lead to some potential confusion and hospital
records later on and after the fact. Is that----
Mr. Brown. That is the start. Can you tell me, can you tell
these subcommittee, No. 1, how many companies there are that
have not reported to you--you have looked at their website
perhaps--but how many there are that haven't reported to you
and how many products those companies make and how many of
those products might be life-threatening?
Mr. Shope. We can do some arithmetic. We certainly know, of
our original estimate of roughly 2,000 companies, there are
less that 200 that we haven't heard from, and we don't expect
that they are manufacturers of any significant volume in that
sample. We have not gone and done an individual company-by-
company comparison to see what kind of product those non-
responding companies make. However, that is something that is
on our plate to take a look at as we continue our effort to
analyze this information.
We don't have a list of the products manufactured by every
company by make and model. We just don't have that information.
Mr. Brown. Don't you need that? Some of them might be life-
threatening perhaps.
Mr. Shope. We can identify by manufacturer if they make a
life-threatening-type product. We are currently developing that
list of manufacturers which would be the focus of our extensive
follow-up effort that we are talking about here.
Mr. Brown. Mr. Willemssen, what should they be doing?
Mr. Willemssen. Well, I want to express one caveat to some
of the numbers that have been discussed. That has to do with,
as of May 10, we show that for about 420 manufacturers, FDA
relies on their web sites to provide information on non-
compliant products. Usually those manufacturers are larger
companies. So in terms of the number of 800 or 900 devices that
are non-compliant, the actual number is significantly higher
than that.
For example, I went on the web site this morning and pulled
up one company, and just within the digital imaging sub-systems
area of that one company, it listed 11 products with a Y2K
issue. So I want to caution you on the numbers that have been
discussed, that the numbers are probably, quite a bit higher,
because we haven't been talking about all of these web sites
that give you an avenue into another whole wide range of
products.
Mr. Brown. Isn't this a pretty serious problem? There are
400 companies on the website; you have spent some time looking
at one and found 11 products. I mean, obviously, you don't
necessarily multiply 400 by 11, but you have a significant
number, some of them probably, life-threatening. Don't we need
to know a lot more than what we know?
Mr. Willemssen. That is why we agree with what FDA is doing
now. You have got to have a list of critical care and life
support items and, based on that list, take the additional
actions that we have talked about earlier. We think that is a
step in the right direction.
Mr. Brown. How do you define critical care? Does FDA define
it? Do you define it? What do you mean?
Mr. Willemssen. I would rely on Dr. Shope's medical
expertise to come up with that definition, but during the
course of work it is clearly something that has come up. Our
overriding criterion is patient safety and where that patient
safety can be degraded because of a Y2K issue in a biomedical
equipment device. We feel that needs to be addressed.
Mr. Brown. Okay. Thank you, Mr. Chairman.
Mr. Upton. Mr. Bilirakis?
Mr. Bilirakis. Well, and I really planned to go into this
with the next panel, too, but we have asked a lot of questions,
and of course, a lot of statistics have been thrown out and
that sort of thing. How difficult would it be for the Congress,
for this committee, to receive the hard data supporting some of
the statements that you have made and some of the responses
that you have given us, Dr. Shope? I mean, you know, the
particular companies that you have contacted and communicated
with; the critical medical devices associated with those
companies, things of that nature. I mean, is that something
that is available that you could just push a button and, in
effect, give us a copy of all of that?
Mr. Shope. Certainly, the data that is on our website is
available in that fashion. We are continuing to work on our
list of these, what we call, high-risk devices, and we expect
to complete that list very shortly. We will use that list,
then, to identify the manufacturers of those types of products.
So, any of the information that we have with regard to what we
know about manufacturers is certainly available. It would be
difficult to produce lists of the products that are on the
manufacturers' websites. We haven't downloaded that
information.
We have to go back and look at the intended purpose of this
website, initially, which was the outgrowth of a joint Federal
agency activity to determine which products would have negative
impacts from the year 2000 and how to get information out to
the Federal purchasers and to the public purchasers of that
equipment. The website was seen to be a convenient method for
doing that. We relied on manufacturers to voluntarily provide
this information because we didn't have a regulatory authority
or regulation on the books that would require that kind of
information to be provided to us.
Mr. Bilirakis. You know, Doctor, with all due respect, I
really don't feel any better about everything. You know, you
and Mr. Hubbard flat out said that you feel that we will be
ready, insofar as the medical devices are concerned, insofar as
the FDA jurisdiction area is concerned. But you can't be very
much help, apparently, as far as hospitals are concerned, the
use of those devices, so to speak, down at that level. And
again, how in the hell did we get ourselves into this kind of a
situation, knowing darn well that the year 2000 was coming, et
cetera, et cetera?
You have enough to know, and I don't want to add anything
additional to your workload, when you can better be using your
time getting ready, rather than giving us any of this hard
data. And I don't know, Mr. Chairman, whether getting that hard
data would be of any consequence as far as help is concerned to
this subcommittee. Maybe we can talk about that rather than
request it now; we can always request it if we feel that it
would be.
But, Mr. Willemssen, you have been kind of chomping at the
bit when Mr. Burr was asking you a question, and Dr. Ganske. Is
there anything more that you want to add? I just want to kind
of give you the rest of my time.
Mr. Willemssen. The issue that I was concerned about was
when some of the numbers were being discussed, and I wanted to
make sure there was some context for those numbers, and that
the numbers that weren't talked about were all of those items
on large companies' web sites, which increases the number
exponentially. So, I just wanted to make sure that item was out
on the table.
Mr. Bilirakis. Yes, sir, Doctor.
Mr. Shope. I just make the comment, the fact that those
items are on the manufacturer's website normally means the
manufacturer has assessed that product; he has looked at the
vulnerability of that product, and he has provided the solution
for that product, or a description of what kind of solution he
is going to provide for that product. So, I think one needs to
know that piece--I think the concern that may still be there
is, how well has the manufacturer done that? That is the kind
of thing that we depend on our quality system for and our
potential follow-up activities to address and get some
additional assurance.
Mr. Bilirakis. Thanks, Mr. Chairman. I still don't really
feel very good about it.
Mr. Upton. Well, make sure you get the end-of-the-year
checkup.
I would just like to note, for those in the audience that
those that don't have the testimony, that the website is
www.fda.gov.
Mr. Bryant, do you have additional questions?
Mr. Bryant. Just a couple of quick questions. I hope that
they have quick answers.
I know all of you have been working very diligently trying
to assess this situation and remediate it, but I am still
unclear--there appear to be some 200 to 400 people out there
who have manufactured medical devices that have not responded
to this survey. Am I understanding your testimony, that the FDA
is going to be more aggressive in contacting these people,
affirmatively contacting them, to determine if they are
bankrupt, if they have merged, if they have disappeared, but
trying to get together this information?
Mr. Hubbard. That is right, Mr. Bryant. We have been doing
that. Our contractors are trying to find them, call them,
whatever way we can contact them, to find out if, in fact, they
still exist, if they are still manufacturing medical devices,
if those medical devices are being sold in the United States or
exist anywhere in the United States. You know, our suspicion
is, as I said, that they are perhaps not marketing products any
longer; they are foreign companies that planned to market here,
never did, or companies that have gone out of business, or such
things as that. We think the vast majority of manufacturers we
have been able to find and asked the questions and gotten the
answers. But, we are not giving up on those 200, either; we are
continuing to look for them.
Mr. Bryant. Are you trying to get help from the hospitals
and the doctors and the people who----
Mr. Shope. We haven't pursued that kind of assistance to
locate these manufacturers. It usually works the other way
around. We hear from the hospitals, ``Can you tell me how to
find this manufacturers,'' as opposed to, ``I found one for
you; here he is.'' I think a comment needs to be made about the
source of our list of manufacturers. That comes from our
registration and listing data base, and that data base
oftentimes can have in it people who are no longer in business
at the time that we use that address list, people who had an
intention when they registered with us that they were going to
go into business, but that never came to fruition, people who
maybe submitted a pre-market submission, but, for one reason or
another, had a clearance for a product but never took that
product to market. So there are a lot of business kinds of
problems that arise that prevent someone who actually
registered and listed with us from continuing in business.
I suspect the large number of the ones that we are trying
to track down now are that type of company that really never
brought a product to market. The other issue is that they may
have a product that they brought to market, but it my not be a
computerized device. It got flagged because they make an
accessory or supply used with the computerized device. So, when
we ask them about computerized device status, they have no real
incentive to respond to us.
In fact, just a couple of days ago, I got a list of 20
companies that our contractor had tried and failed on three
different occasions to try to contact. We will now take that
list and see if there are any products that we can associate
with any of those companies that would raise concern. If not,
we will have to say this is a list of 20 that we are writing
off as non-contactable and products of non-concern.
Mr. Hubbard. So, if it is any consolation, Mr. Bryant, it
is unlikely that these manufacturers, if they exist at all, are
making any large number of products where there is a very large
problem. But, again, even if there is a small problem, we would
like to track them down.
Mr. Brown. Okay. Mr. Willemssen, do you have any comments.
Mr. Willemssen. One thing that I would add related to that
is to the extent that, if FDA cannot get that information, then
they need to consider publicizing that list of non-respondents
on its web site, so that hospitals are aware of who those
manufacturers are, and if they have equipment from those
manufacturers in their inventory, they will want to think twice
about whether to use it or not.
Mr. Brown. Very good. Thank you.
Mr. Upton. Dr. Ganske? Okay. Mr. Burr.
Mr. Burr. Thank you, Mr. Chairman.
Let me ask you, Mr. Hubbard, somebody earlier asked about
the possible 510(k)'s that were in process now.
Mr. Hubbard. Right.
Mr. Burr. What process do you go through to assure of
compliance?
Mr. Hubbard. I will have to ask Dr. Shope to answer that.
Mr. Burr. Okay. Dr. Shope.
Mr. Shope. The process for 510(k), and basically for
software products, they are very similar between a 510(k) and a
pre-market approval application. That is, the manufacturer, if
they are making a computerized device, will provide to us,
based on what we call our level of concern or the level of risk
that device could present to a patient, varying levels of
information and documentation about the software development
process used in developing that device. What we would see are
artifacts of that software development design process, such
things as the overall description of the design process, the
types of verification and validation activities the
manufacturer undertook, and perhaps some sample test records
and test data for the very-high-risk devices. That comes in as
part of the application and is reviewed by the pre-market
reviewer or sometimes by some of our software specialists. It
is not a line-by-line review of the code.
Mr. Burr. In your estimation, is it possible for a device
that is non-compliant to be approved today?
Mr. Shope. It is probably possible if a manufacturer makes
a good case to us that, ``I have been working on this product
for 2 years.''
Mr. Burr. The manufacturer makes the case that it is
compliant, and in fact, the product is not compliant in some
fashion?
Mr. Shope. Certainly, that is possible. Our review process
is not foolproof.
Mr. Burr. You mentioned earlier, Mr. Hubbard, resources.
Mr. Hubbard. Yes, sir.
Mr. Burr. I won't dispute it with you. I will only ask, did
the FDA make a line-item request in the 1999 budget for
specifically the compliance resources needed for this?
Mr. Hubbard. Well, what we have done, Mr. Burr, is I
believe Congress appropriated a sum of funds for Y2K across the
administration as being the funds that have been managed by the
Office of Management Budget at the White House, and agencies
have gone to that, to the OMB, for specific Y2K-related
activities. We have done so for our internal systems correction
and had some money funded. We have done some of our emergency
response process, so to have our field prepared if problems
occur later in the year, and there has been funding for that.
We are preparing now to survey drug and device manufacturers to
ask more questions about the compliance.
Mr. Burr. So, you do have sufficient resources?
Mr. Hubbard. Well, certainly funding is coming. The
activity we describe today has not been funded, and we will
have to go back to the OMB and ask to release some of those
funds for that activity.
Mr. Burr. But, you have never made a line-item request from
Congress for money for compliance?
Mr. Hubbard. Not to my knowledge, but, again, because there
was this money appropriated by Congress for all of the agencies
across----
Mr. Burr. How about in the 2000 budget, even though that
doesn't kick in until extremely late in the year; there wasn't
a specific line item in the request?
Mr. Hubbard. Again, I think the reliance has been on these
funds already appropriated, Mr. Burr.
Mr. Burr. May I ask you--let us assume for a minute that
you ID an non-compliant device. What happens?
Mr. Hubbard. Depending on the risk, obviously, if we found
one today, we would be advising the manufacturer that they need
to do to make it compliant. We have the authority, if we
believe that device poses a risk to health and could fail some
way, we have authority to have it seized or the manufacturing
might be stopped, or to have it recalled if it is out in the
marketplace.
Mr. Burr. How do you go through that market recall?
Mr. Shope. The market recall process is in section 518 of
the act.
Mr. Burr. No, I am asking specifically, what process kicks
in where you ask or request the recall? The actual products to
go back to the manufacturer to be pulled off of the market, not
to be used, what process does the FDA go through?
Mr. Shope. We would be working with the manufacturer to
identify purchasers of those products.
Mr. Burr. Manufacturer would supply you with the list of
people that purchased?
Mr. Shope. Yes, sir. I am not an expert on these
compliance-type operations. So, I am getting into unknown
territory from my personal knowledge to describe this
compliance activity.
Mr. Burr. I hope you understand, what I am trying to
determine is, to what degree do we search for the relevant
information when we identify we have a potential health risk in
the marketplace versus what are we doing now with our ability
to identify equipment that may or may not have a Y2K compliant
problem? It seems like the two processes are significantly
different. Would you agree?
Mr. Shope. I am not sure I can compare the processes.
Mr. Burr. Well, let me put it this way: Have we in any of
the Y2K-compliant activities at FDA sought from the
manufacturer every location that purchased a specific device
and contacted to say, ``You purchased this. We understand it is
non-compliant to Y2K. We would advise you to go through this
process.''?
Mr. Shope. No, sir. We haven't done that because I think it
is a little premature for that decision. What would be
happening now would be manufacturers----
Mr. Burr. How close to January 1 do we get before it is no
longer premature?
Mr. Shope. I think it has to be pretty close if the
manufacturer is working on a fix and is going to make that
available.
Mr. Burr. Define ``pretty'' for me, because I need to know
at what time do we cry ``wolf'' and start notification, and how
long does it take you to notify?
Mr. Shope. I can give you a personal view here. If it is
after October 1 and we come across a device that could present
a significant risk to patient health, and the manufacturer
hasn't taken the appropriate action to make a solution
available, I think we would get very engaged with that
manufacturer about his intentions.
Mr. Burr. Now, let me ask you, because there is still a
discrepancy today about whose responsibility it is about
oversight, can I safely assume there are some non-compliant
devices in hospitals and non-compliant devices in doctors'
offices?
Mr. Shope. Yes, sir.
Mr. Burr. Private homes?
Mr. Shope. Possibility.
Mr. Burr. Okay. There is still a disagreement over whose
primary responsibility it is for hospitals, doctors' offices,
and I don't even think we have discussed private homes. Who
will take the lead if we get to October 1, you identify a piece
of equipment or several pieces of equipment, the alarm goes
off, who takes the primary lead on hospitals? You, HCFA, who?
Mr. Shope. I think the realistic scenario would be, if
there is a product that has a problem that is not being
appropriately addressed and it rises to the level, we could do
a mandatory recall-type activity. Typically, before we get to
that level, the manufacturer has exercised the voluntary recall
and has notified purchasers and had that product removed--
either a product withdrawal or some kind of voluntary recall,
offering a solution or an alternative to that solution.
Mr. Burr. Mr. Chairman, could I ask for unanimous consent
for 2 additional minutes?
Let me skip over to the in-home use. Has FDA determined the
amount of time it would take, once you have requested of a
manufacturer to contact every person who had a specific non-
compliant devices if it were in people's homes, how long would
it take a manufacturer to go through the process of
notification and for the FDA to receive assurances that
everybody had been contacted and that these devices had been
taken care of? Is that something that you feel could be done in
90 days?
Mr. Shope. It is a little bit beyond my expertise, but I
suspect that a critical-type device like that manufacturers
could do a reasonable job of identifying and providing
information in a 90-day timeframe.
Mr. Burr. So, the likelihood is that they would have to
contact a distributor of medical devices or something, who then
sold that or has it out on rent or loan or something to an
individual, and that whole chain is going to work, and they are
going to contact that individual and have all of that
information back in a 90-day timeframe? Do you feel like that
is possible?
Mr. Shope. I am a little beyond my expertise here in terms
of how fast these compliant recall-type activities work. I am
sure we can provide some information on that.
[The following was received for the record:]
FDA routinely oversees recalls of all products regulated by the
Agency under its voluntary recall authority, and, less frequently, has
required recalls of medical devices under the authority of the Federal
Food, Drug and Cosmetic (FD&C) Act. The Agency's recall authority
provides FDA with a highly effective and expeditious means of
protecting the public from potentially harmful products. The length of
time the entire recall process takes can vary widely based on the
device and the extent to which it has been distributed.
Although the ultimate goal of any recall is to repair a dangerous
product or remove it from distribution, the primary public health goal
of the recall authority--halting the use of a product that poses a
health risk--can be accomplished during the initial stages involving
notification and publication of information concerning the device.
Under the mandatory recall requirements, the individual or firm to whom
FDA issues the order must immediately issue notifications and
instructions to cease use. This is accomplished through directed
notification to the manufacturers, distributors, purchasers, etc., and
also through press releases. These actions ensure that health care
workers can make informed decisions about patient care.
FDA's mandatory recall authority is reserved for medical devices
that pose a high degree of risk to the public health. Section 518(e) of
the FD&C Act requires that the Agency first order an appropriate
individual to issue notification of the risk of the device to user
facilities and health professionals, along with instructions to cease
use of the device. The appropriate individual is the individual most
well-situated to locate the device and contact those responsible for
its use. This person frequently will be the manufacturer, although FDA
may use its authority under 518(e) to impose orders on distributors,
importers, or other individuals the Agency determines are best able to
respond to the requirements of the order. Most mandated notifications
can be completed within 48 hours.
The procedures under FDA's voluntary recall regulation are more
flexible. Under its procedures for voluntary recall, the Agency can
work with manufacturers to initiate a variety of actions, including
notifications and recommendations concerning discontinuation or
modification of use of the product. Voluntary recall procedures are
available for all levels of product risk.
The length of time it will take to remedy the device or remove it
from distribution will depend on the number of devices in distribution
and other factors; FDA cannot predict this time period in the absence
of a particular set of facts. FDA'S mandatory recall regulations,
however, provide authority for the Agency to respond with immediacy to
serious threats. Although the mandatory recall regulations require that
FDA provide an opportunity for a hearing before amending a notification
order to include recall, the preamble to the regulation makes clear
that FDA may issue its notification order, hold its hearing, and amend
the order to require recall all in a single day when the public health
requires immediate action. 61 FR 59004, 59007 (November 20, 1996). Only
an extreme risk would dictate such an urgent response. FDA's recall
authority was designed to empower the Agency to respond with Urgency to
significant health threats. FDA anticipates this authority will enable
the Agency to control health risks it identifies by October 1, 1999,
(or an earlier date) within 90 days.
Mr. Bilirakis. If the gentleman would yield?
Mr. Burr. Yes, back to you.
Mr. Bilirakis. So this gets back to your ``pretty close,''
``pretty close'' point, Doctor. The discussion here is 90 days,
and I guess I am not sure where the 90 days came from; maybe I
wasn't paying attention. I was ordering something to eat.
Mr. Burr. There is a lead time in any case, particularly if
we are going to go to the private homes.
Mr. Bilirakis. And that sort of thing--I don't know, I hope
we are not really making a mountain out of a molehill here. I
think it is just significant that we not leave anything
unlooked at. But keeping in mind the timeline, you know, there
is a period of time here for recall and getting into the
private homes and getting into the hospitals, et cetera, et
cetera. When you say, ``pretty close,'' what are we talking
about there? You are certainly not talking December, are you?
Are you talking December or are you talking November or are you
talking October? October is 30 days; September is really 30
days.
Mr. Shope. I think we would be wanting to have some good
understanding of the situation by October 1 in order to be
realistic about taking care of a significant problem. I would
like to add that I have a very hard time thinking about a
device used in the home that is date-dependant in a way that it
would present a significant risk to the patient. There are
blood glucose monitors that are used in home use, and some of
those do trending of readings, and there is a potential for
problems there with some models of that type of device. But, I
am hard-pressed to think of other products used in the home
where a date functionality is critical to the use of the
device. But, that is not to say there may not be something.
Mr. Burr. Doctor, have we ruled out every implantable
device possibly having a Y2K-compliant problem?
Mr. Shope. We know of no implantable devices that have Y2K-
date dependencies.
Mr. Burr. I appreciate the answer, but I asked it in a
different way. Are we assured that there are no implantable
devices that might have a Y2K problem?
Mr. Shope. I am not sure that I can answer it in any other
way than the fact that we are not aware of any product like
that. We have been in touch with the manufacturers of such
things as pacemakers, implantable infusion pumps, implanted
defibrillators. It just doesn't make sense to design those with
an unneeded date dependency. And none of those products work in
a way that requires them to have knowledge of the date. Those
things use timing circuits, but when they use timing circuits,
they are using a register counting oscillations of a
oscillator. It is the external device that maybe interrogates
that device that adds the date-time type of information to the
record that it brings out from that device.
Mr. Burr. Well, I thank all of you. This has been
enlightening. Just as a personal observation, I think we still
have quite a bit of work to do. I don't think that I would find
disagreement from any of our panelists. I would also urge my
colleagues that we, as a committee, try to work with the FDA
and with all the agencies that have some oversight. I would
encourage the FDA to encourage HHS to draw a little clearer
lines of responsibility as it relates to hospitals and rural
health centers and doctors' offices. I think it is important
that at least that question have an answer versus to pass it
off on the manufacturers. It may be their responsibility. If it
is, then let us make sure that we clearly communicate it. If it
is not, let us make sure that we know which arm of the Federal
Government is going to be responsible for notification.
I yield back.
Mr. Hubbard. We will follow up on that, Mr. Burr.
Mr. Bilirakis. I would hope, Mr. Chairman, if I may, I
would hope that we get our heads together and schedule another
hearing, maybe like in September, something of that nature, as
we get closer to these timelines.
Mr. Upton. I think that would be a very good idea.
If no other members have questions----
Mr. Brown. I would just add, thank you, Mr. Chairman. If we
do another hearing in September, as Chairman Bilirakis
suggests, and we do find ourselves continuing to give more
responsibility and expect more responsibility to and expect
more from the FDA, that we look at their funding also. That is
something that, at least, we should consider because Mr.
Hubbard's comments on the technical expertise, in response to
my question, sound like partly a paucity of resources, in
addition to a lack of technical expertise. I think we should at
least consider that in an emergency situation, if it comes to
that.
Mr. Upton. Thank you. Panel, you are excused. Thank you
very much for your testimony, and you may be getting some
questions further down the road from us as well.
Our next panel includes Mr. Kent Smith, who is the global
project manager of Baxter Health Care Corporation. He is the
spokesperson for the Health Industry Manufacturers Association,
HIMA. Mrs. Noel Brown Williams, senior vice president at
Columbia HCA Health Care Corporation, spokesperson for the
Federation of American Health Systems. And Mr. John C. Nunn,
vice president for patient care services from Henry Ford
Hospital, representing the American Hospital Association.
We are delighted that you are here this morning, and we
appreciate you listening, certainly, to the first panel. And as
you heard me say to the first panel, we have a long tradition
in the Oversight and Investigations Subcommittee of taking
testimony under oath. Do you have any objection to that?
[No response.]
Seeing none, also, under House rules, you are allowed to
have counsel, if you prefer that. Do you have a need for a
counsel?
[No response.]
Then if you would stand and raise your right hand?
[Witnesses sworn.]
You are now sworn in, and as we did with the first panel,
your entire statement will be made part of the record. If you
would like add or summarize, but try and observe the 5-minute
rule, that would be terrific. We will start with you.
TESTIMONY OF KENT T. SMITH, GLOBAL PROJECT MANAGER, BAXTER
HEALTHCARE CORPORATION, ON BEHALF OF THE HEALTH INDUSTRY
MANUFACTURERS ASSOCIATION; NOEL BROWN WILLIAMS, SENIOR VICE
PRESIDENT, COLUMBIA HCA HEALTH CARE CORPORATION, ON BEHALF OF
THE FEDERATION OF AMERICAN HEALTH SYSTEMS; ACCOMPANIED BY DON
WORKMAN, COLUMBIA HCA HEALTH CARE CORPORATION; AND JOHN C.
NUNN, VICE PRESIDENT FOR PATIENT CARE SERVICES, HENRY FORD
HOSPITAL, ON BEHALF OF THE AMERICAN HOSPITAL ASSOCIATION
Mr. Smith. Thank you, Mr. Chairman. As mentioned, I am the
chairman of Baxter Healthcare Corporation.
Mr. Bilirakis. Will you pull the mike closer?
Mr. Upton. Yes. Pull the mike up a little bit closer.
Mr. Smith. That is the first time I have ever heard
somebody tell me I couldn't speak loud enough, by the way.
I am the chairman of Baxter Healthcare Corporation's
committee on the year 2000. And just for your information,
Baxter is a global medical products and services company that
provides critical therapies for patients' life-threatening
conditions. I am very pleased to testify today on behalf of
HIMA and the medical device industry's Y2K readiness.
The device industry shares the concern of healthcare
providers and patients regarding the year 2000 date problem.
Over the past year, HIMA has stepped up the challenge and
worked effectively with the FDA, the Veterans' Administration,
and the National Safety Patients' Partnership, as well as
others, to identify critical issues, communicate Y2K
compliance, and ensure patient access to safe and effective
devices on January 1, 2000.
To date, HIMA members are at different levels in their Y2K-
compliance process. Most are now focused on the Y2K business
contingency planning process. And I want to emphasize the point
that all HIMA members have a year 2000 process in place today.
On device compliance, HIMA has worked closely with the FDA and
the Veteran's Administration to ensure the FDA's year 2000
clearinghouse is an effective central data base for Y2K device
compliance information.
HIMA has also ensured a 100 percent response rate from its
800 member companies who manufacture 90 percent of the devices
sold in the country in the US. They communicated with 6,000
non-member companies, urging them to respond to the FDA to
ensure their devices were Y2K compliant, which we have heard
from. They have made phone calls to non-HIMA member companies
who did not respond to the FDA or the VA request for this
information. And they have sponsored advertisements with the
FDA and the VA in industry trade magazines, urging companies to
respond to the FDA request on the Y2K status information. So,
in summary, I believe the device industry has risen to the
challenge of coordinating and effectively communicating the
medical device industry's progress toward Y2K compliance,
though we still have some work to do.
As a window into the activities of a large company with a
diverse product line, let me quickly highlight elements of
Baxter's comprehensive Y2K program which have been in place
since early 1997. Our product compliance checking is complete,
and it identified fewer than 20 products with Y2K issues.
Modifications and replacements for these products will be
complete by mid-1999. Information regarding our Y2K-compliance
status and implementation solution has been available since
December 1, 1998. We have sent out over 30,000 compliance
letters to customers worldwide, describing product issues and
the process for implementing product fixes.
To evaluate our suppliers, we have required each supplier
to communicate its Y2K compliance. We have over a 95 percent
response rate to questionnaires sent to 7,000 critical
suppliers. We are conducting face-to-face as well as telephone
audits with these targeted suppliers.
With respect to our manufacturing plants, 80 percent of our
manufacturing and facility systems have been fixed.
Implementation will continue through the mid-part of this year
for that piece. And finally, we have a very extensive business
contingency planning process in place for all of our businesses
and regions around the world, focused on customer
communication, human resource planning, and inventory
management.
With respect to contingency planning that I just mentioned,
I participated in a HIMA-wide teleconference to educate the
other HIMA members on Y2K contingency planning. And while these
are a normal course of business, in this particular case, we
happen to know when the year 2000 transition will occur, and so
it is easier to plan from a contingency planning perspective.
HIMA has now turned its attention to the serious issue of
potential or provider stockpiling, if you will, or provider
hoarding. As a member of the healthcare sector of the
President's Council on the Year 2000 Conversion, HIMA is
working with the American Hospital Association, the Health
Industries Distributors Association, the FDA, HCFA, and others
on a White House-sponsored roundtable on hospital supplies to
be held in early June.
In closing, we are encouraged by the progress of our
industry in achieving Y2K readiness. However, we cannot achieve
success alone. The government must play an integral role in
helping the diverse and segmented healthcare sector coalesce in
responding to Y2K. You can help us by supporting any consensus
that is developed in the forthcoming White House roundtable. In
so doing, you will help every patient in America. Working
together, we can assure patients that the healthcare sectors
will continue to provide value and safety into, during, and
beyond January 1, 2000.
And obviously, I would be glad to take any questions you
may have.
[The prepared statement of Kent T. Smith follows:]]
Prepared Statement of Kent T. Smith, Chairman, Year 2000 Committee,
Baxter Healthcare Corporation On Behalf of the Health Industry
Manufacturers Association
My name is Kent Smith. I am Chairman of Baxter Healthcare
Corporation's Committee on Year 2000. Baxter is a global medical
products and services company that provides critical therapies for
patients' life-threatening conditions. The company's products and
services in blood therapies, biopharmaceuticals and blood collection,
separation and storage devices, cardiovascular medicine, medication
delivery and renal therapy are used by health care providers and their
patients in 112 countries.
I am pleased to testify today on behalf of the Health Industry
Manufacturers Association (HIMA) on the status of the medical device
industry's Year 2000 readiness. HIMA is a Washington, D.C.-based trade
association that represents more than 800 manufacturers of medical
devices, diagnostic products, and medical information systems. HIMA's
members manufacture nearly 90 percent of the $62 billion in health care
technology products purchased annually in the United States and more
than 50 percent of the $147 billion purchased annually around the
world. As such, HIMA is the largest medical technology trade
association in the world.
The medical device industry recognizes and shares the concerns of
health care providers, patients, and the general public regarding the
possible effects of the Year 2000 computer date problem. The American
medical technology industry has built a reputation for leadership and
excellence that is recognized worldwide. It goes without saying that
the health and safety of patients constitute the paramount concerns of
our industry.
Over the past year, I believe that the device industry has stepped
up to the challenge and has worked closely and effectively with key
constituencies including the FDA, the Department of Veterans' Affairs,
the National Patient Safety Partnership and others to identify critical
issues, communicate the industry's compliance, and ensure patient
access to safe and effective medical devices on January 1, 2000 and
thereafter. I can speak directly for Baxter Healthcare Corporation when
I say that we are devoting significant resources to assure the Year
2000 compliance of our devices and to communicate our compliance status
to interested parties. I am personally aware of numerous other
companies that are acting similarly. I am confident that the medical
technology industry will do whatever is necessary to maintain the
health and safety of our patients.
In my testimony today, I will outline for the Subcommittee the
numerous activities, both past and present, that HIMA has undertaken to
ensure that both HIMA member and non-member companies fulfill their
responsibility to provide compliance information to appropriate
government entities as well as their customers. I will also share with
you the comprehensive Year 2000 compliance program that Baxter
Healthcare has developed.
I would be remiss, however, if I did not express to you the
legitimate liability fears of the medical technology industry--fears
that are shared by other industries. Congress recognized these in
enacting the Year 2000 Information and Readiness Act that has helped
tremendously to encourage all industries to disseminate Year 2000
compliance data without fear of liability. The House has now taken the
second step of passing liability legislation that will help create an
environment that will encourage remediation and discourage frivolous
lawsuits. It is our hope that the House, the Senate, and the
Administration will be able to reach a compromise to ensure that
liability legislation is passed as soon as possible.
A Diverse Industry Poses Unique Challenges
The medical device industry is extremely concerned about the
potential hazards associated with the Year 2000 problems and has put
substantial effort into ensuring that medical devices function properly
and safely during and after the century change. We have committed to
Congress to work with the federal government and other concerned
parties to ensure that information about Year 2000 medical device
compliance is publicly available. While we remain confident that there
will be few disruptions to patient health care as a result of non-
compliant medical equipment, it might be useful to understand the true
diversity of the medical technology industry.
More than 50 scientific and engineering disciplines, including such
diverse fields as solid state physics and holography, are involved in
the development of our products. Over 50 different medical specialties,
such as orthopedic surgery, cardiology and ophthalmology, utilize the
industry's products in applications throughout the human body. There
are more than 3,000 distinct, major product lines, and approximately
84,000 individual products. For these reasons, the challenge posed by
the Year 2000 bug does not represent a single problem that will yield
to a single solution. For the majority of cases, solutions developed by
one firm likely will not apply to, or be feasible for, others. Rather,
each company faces a unique set of circumstances involving its own
technologies.
Further, while the number of electrical medical devices containing
software has been rising, it is important to understand that many of
the highest risk devices vital to keeping patients alive are not date
sensitive. For instance, many have cited the potential Year 2000 risks
associated particularly with pacemakers and implantable defibrillators.
Pacemakers and implantable defibrillators are required to operate at
all times regardless of the day or date. We know of no pacemakers or
defibrillators that are date dependent.
HIMA's Year 2000 Activities
As a matter of course, HIMA has strongly encouraged its members to
work to ensure that their devices are Year 2000 compliant and to
communicate Year 2000 compliance status to their customers. We have
developed and executed a comprehensive program to advise HIMA member
and non-member companies regarding their responsibility to provide
compliance information to the government and have worked closely with
the FDA and others to disseminate necessary information.
HIMA has also:
<bullet> Established a member committee to advise on and oversee the
Association's efforts to successfully address Year 2000 issues.
<bullet> Created a Year 2000 section on HIMA's Web site to communicate
with the public and our members on Year 2000 issues.
<bullet> Consistently reached out to all segments of the industry
including the National Electrical Manufacturers Association
(NEMA), and the Medical Device Manufacturers Association (MDMA)
to coordinate our efforts and to help ensure that critical Year
2000 messages reach virtually all device manufacturers.
Early in the Year 2000 debate, an important coalition--the National
Patient Safety Partnership--comprising the Department of Veterans'
Affairs, the American Hospital Association, the American Nurses
Association, and others concerned about the impact of the Year 2000
problem on patient health, proposed the development of a central
clearinghouse on the compliance status of medical technology. Other
private organizations, such as Rx2000 Solutions Institute, also called
for centralized databases.
HIMA has worked diligently and closely with the Food and Drug
Administration (FDA) and the Department of Veterans' Affairs to help
the FDA's Year 2000 Biomedical Equipment Clearinghouse become a central
collection point for Year 2000 device compliance information. The
initial focus of the FDA clearinghouse effort was to gather information
on non-compliant devices. In support of that critically important goal,
HIMA:
<bullet> Ensured a 100-percent response rate from HIMA's 800 member
companies who together manufacture 90 percent of the medical
technology products sold in the U.S. market.
<bullet> Communicated with more than 6,000 primarily small non-HIMA
member companies in the industry urging them to respond to the
FDA request for Year 2000 status information and to ensure that
their devices are Year 2000 compliant.
<bullet> Sponsored advertisements with the FDA, the Department of
Veterans' Affairs, and other industry associations in key
industry trade magazines urging device companies to respond to
FDA's request for Year 2000 status information.
It is important to note that in the current device industry
environment of mergers and acquisitions, it is not always obvious how
one company may be affiliated with another, or which corporate entity
should be the responsible reporting entity for a particular product. It
is accurate to describe our industry as something of a corporate maze.
For example, HIMA's membership of more than 800 companies actually
consists of 300 companies and parent companies and their more than 500
separate subsidiaries and divisions. For these reasons, HIMA also:
<bullet> Asked each member company to designate an individual who is
responsible for coordinating Year 2000 activities.
<bullet> Worked with the FDA and the VA in an effort to ensure that
their communications were going toY2K coordinators, especially
in instances where they were receiving no response.
<bullet> Made calls to non-HIMA member companies who had failed to
respond to the VA and FDA requests for Year 2000 information to
urge them to post their compliance information on the FDA
Biomedical Equipment Web site.
Of the more than 13,000 FDA-registered device companies, the FDA
identified 1,935 whose products are likely to have a date-dependent
function. We understand that FDA's non-response rate is now just over
200 companies. We can probably assume that many of these companies are
no longer in business.
More recently, in an effort to provide ``one stop shopping'' for
health care providers on Year 2000 compliance information, the FDA has
expanded their Web site to include information on Year 2000 compliant
devices. HIMA worked closely with the FDA to help develop a workable
template in order to facilitate a better industry response. We also
strongly encouraged our members to respond to this new FDA request for
information. HIMA's President urged all HIMA members, in a memorandum,
to provide the requested information. HIMA also used its Web site to
promote compliance with the request.
Baxter Healthcare Corporation Year 2000 Actions
As a window into the activities of a large medical technology
corporation with a diverse product line, I would like to highlight the
Year 2000 progress and awareness initiatives Baxter Healthcare
Corporation has undertaken. Given our goal of providing quality care
for patients, Baxter has since early 1997 been actively addressing Year
2000 issues relating to our customers, employees, suppliers,
manufacturing and facility systems, products, services and internal
systems. We have made tremendous progress and we anticipate that we
will meet our goal of being Year 2000 compliant by September 30, 1999.
To date, we have spent approximately 85 percent of our $135 million
Year 2000 budget to address our role in the health care supply chain.
Baxter's Year 2000 initiatives are comprehensive and include a variety
of activities.
Products--Baxter delivers critical therapies for life-threatening
conditions. It is important work. Important to patients whose lives
depend on our products and services. Important to health care
professionals who count on us to help them treat their patients.
Consequently, providing timely information regarding the status of Year
2000-affected products and services is one of the Year 2000 team's top
priorities. Baxter's product and software engineers have identified
fewer than 100 electronic medical products that could have been
affected by Year 2000 issues. Information regarding the Year 2000
compliance status and implementation solutions for Baxter's electronic
date-dependent products was available December 1, 1998. Our compliance
checking has been completed and identified fewer than 20 products with
Year 2000 issues. Product modifications and replacements are expected
to be complete by mid-1999.
Customers--The Year 2000 challenge isn't just about rewriting
computer code, it's about being responsive to customers. We are
actively working with customers to address various Year 2000 issues,
including medical device compliance, viability of the supply chain, and
Electronic Data Interchange (EDI). Beginning in June 1998, Year 2000
certification documentation (letters, compliance certificates, and
Baxter's compliance definition) began to be distributed to customers we
identified as having date-dependent products.
Also in June 1998, Baxter launched its Year 2000 Web site, which
includes a complete list of Baxter's electronic medical products,
detailed information regarding Year 2000-affected products, a customer
inquiry form, compliance definition, product supply requirement
information and other information on Baxter's Year 2000 Program. To
date, we have responded to over 4,500 Year 2000 customer inquiries and
have mailed over 25,000 compliance letters to customers worldwide.
40,000 Baxter brochures in 10 languages were distributed to customers,
suppliers, and employees to help increase global Year 2000 awareness.
In early 1999, all customers who communicated with Baxter through
EDI were notified about Baxter's implementation of the newest EDI
standards that are Year 2000 compliant. While a change to a newer
version may not have been required in all cases, it is the preferred
way to communicate with Baxter.
Suppliers--Suppliers in the broadest sense include all those
parties that provide material, products, or services to Baxter. One of
the biggest risks facing our global company is the potential failure of
key strategic business partners, suppliers, and third parties on which
we depend to address Year 2000 issues. To evaluate our suppliers, we
have a coordinated effort through Baxter's Purchasing Council to
address our raw materials/finished goods and maintenance, repair and
operations (MRO) suppliers. Each Baxter facility is also requiring
their local suppliers to communicate their progress toward Year 2000
compliance. These suppliers may include utilities, telecommunications,
third-party logistics providers, distributors, service providers,
property managers and any other critical business supplier. We have
received an over 90 percent response rate from questionnaires sent to
our identified 7,000 critical suppliers asking for their Year 2000
readiness information. We are also conducting face-to-face and
telephone audits with targeted suppliers. Our goal is to complete these
audits by mid-1999.
Manufacturing--Baxter manufacturing worldwide adheres to high
standards of quality. Our manufacturing plants are consistently
recognized for their dedication to total quality and manufacturing
excellence. As a health care manufacturer, Baxter has over 70
manufacturing facilities, distribution centers and replenishment
centers around the world. To date, 80 percent of Year 2000
manufacturing and facility systems have been fixed and implementation
will continue through mid-1999 according to plan.
Internal Systems--As a global company, Baxter has literally
thousands of internal interconnections and interactions amongst and
between computer operating systems. In an effort to make it easier for
our customers to do business with us, enhance our employees' ability to
respond to customers, as well as improve our overall economic
efficiency, we are implementing a global integration project. This
project will implement software upgrades that are certified as Year
2000 compliant as well as integrate our operational processes. To date,
Baxter has achieved all major milestones relating to systems
initiatives with approximately 75 percent of systems implementations
complete as of March 1999.
Contingency Planning--As part of its contingency planning and
awareness efforts, Baxter is:
<bullet> meeting with customers to discuss their requirements and
obtain key information as input into our contingency plans;
<bullet> contacting customs officials to identify potential Year 2000
issues;
<bullet> monitoring the Year 2000 progress of its key distributors and
suppliers;
<bullet> assessing the viability of the entire supply chain and
developing appropriate contingency plans at each of its
manufacturing facilities worldwide;
<bullet> upgrading, replacing or modifying all major computer-based
business and finance systems where necessary to enhance
interactions with customers; and
<bullet> developing strategies for communicating with customers during
the Year 2000 transition.
We are confident our comprehensive Year 2000 plan and
implementation strategy will help us continue our mission of providing
critical therapies for life-threatening conditions.
HIMA Contingency Planning Activities
With respect to company operations' contingency planning, HIMA has
helped to educate its membership on the importance of Year 2000
contingency planning and the various components involved. For example,
I participated in an association-wide teleconference to educate my
colleagues on the many aspects of the contingency planning process in
order to avoid critical interruptions of the supply chain and to
enhance communications with customers. Year 2000 contingency planning
is focused on developing alternate operating procedures that support
business continuity. It should be noted that contingency plans are part
of a company's normal course of business. Prudent companies must
protect their operations during storms, strikes and other potential
disruptions. In the case of Year 2000, these plans could range from
taking customer orders by hand instead of by computer to establishing a
Year 2000 command center for critical communications during the Year
2000 transition.
The President's Council on Year 2000 Conversion is working to
evaluate the readiness of critical industries. To support the Council's
initiative, HIMA circulated to its members a survey based on a template
prepared by the President's Council. While we have not completed our
analysis of the survey, our initial work indicates that the companies
that supply the bulk of the country's medical devices are well on the
way to complete Year 2000 readiness before the end of the year. The
results collected thus far have given us a handle on general industry
trends. For instance, we believe the companies that sell the vast
majority of medical devices sold in the U.S. are communicating with
their suppliers and their customers using multiple means such as face-
to-face meetings, 800 numbers, Web sites, e-mail, etc. In addition, the
preliminary results indicate that these same companies expect to be
Year 2000 compliant with respect to both their products and their
operations.
Preemptive Buildup of Supplies
On another equally important front, HIMA has recently turned its
attention to the more serious issue of the potential for preemptive
inventory build-up or stockpiling. As January 1, 2000 nears, serious
concerns have been expressed throughout the supply chain that some
providers may, as part of their contingency planning, preemptively
hoard supplies. As a member of the Health Care Sector of the
President's Council on Year 2000 Conversion, HIMA is working closely
with the American Hospital Association, the Health Industry
Distributors Association and others on a White House-sponsored
Roundtable on Hospital Supplies to be held in early June.
We expect the Roundtable to be a major source of valuable
information and policy development that will relieve the pressure
related to concerns over potential hoarding of hospital supplies. For
instance, a possible outcome could be an industry/health care provider
consensus that would, in effect, limit the amount of inventory
providers would purchase to previous historical levels plus some
minimal additional amount.
Proposals for Independent Verification of Industry Test Protocols
A number of parties, including the General Accounting Office, have
called for third-party verification of medical technology Year 2000
test protocols. Others have advocated user or third-parting testing of
devices. Some have argued that FDA should properly take on such
responsibilities. Still others have called on industry to make public
its test protocols as well as detailed testing results. We would like
to highlight a number of concerns with such approaches:
<bullet> It is unlikely that enough independent third-party test
organizations exist to analyze and process the highly complex
test protocols associated with thousands of devices in the
available time.
<bullet> It would take tremendous resources and staffing for any
organization, including the FDA, to begin to verify
independently the numerous testing protocols involved for each
model of each device, some of which for complex devices can
approach 100 pages.
<bullet> Making public test protocols assumes that the provider
technicians responsible for such testing would be able to
properly and safely use and understand the protocols.
We believe that at this late date, such activity would be a
misdirection of resources. We understand that this view is shared by
ECRI, a leading independent, non-profit research agency for health care
technology and the Department of Veterans' Affairs, which expressed
this opinion in several of our meetings with them. We have attached a
slide prepared by the chief biomedical engineer of the Department of
Veterans' Affairs describing the reasons for not entering into a major
program to retest medical devices.
Medical device manufacturers are strictly required by the FDA to
verify and validate all product changes affecting patient safety. These
activities are undertaken as part of each company's Design Control
program under the FDA Quality Assurance regulation. These rules require
written procedures for design change validation and verification, and
independent internal audits of quality assurance activities. There are
severe sanctions for failure to validate changes, and FDA has
significant inspection authority to assure compliance. It is difficult
to conceive that either users or third parties can more effectively
verify device Year 2000 readiness than the manufacturers who originally
designed the devices.
Conclusion
In closing, HIMA will continue to work on a variety of fronts to
ensure that the medical technologies on which millions of patients
depend continue to function safely and effectively as we move into the
next millenium. We want the patients who we serve as an industry to
have confidence in us, and we will continue to do whatever we must to
deserve their trust. We are committed to working cooperatively with
anyone who shares this goal. We are open to suggestions and look
forward to working with members of the Subcommittees.
Mr. Upton. Thank you very much.
Mrs. Williams.
TESTIMONY OF NOEL BROWN WILLIAMS
Ms. Williams. Good afternoon, Mr. Chairman and members of
the subcommittee.
Mr. Upton. Could you just put the mike just a little bit
closer?
Ms. Williams. A little bit closer. How is that?
I am pleased to appear before you today on behalf of
Columbia HCA Health Care Corporation, who is a member of the
Federation of American Health Systems. The federation
represents nearly 1,700 hospitals. I am here today to discuss
Columbia HCA's activities and experience concerning year 2000
and the medical devices.
Columbia HCA is one of the leading healthcare service
companies in the United States. We currently operate 236
hospitals throughout the country and employ approximately
225,000 workers, each of whom is committed to the care and
improvement of human life. Columbia HCA estimates that we will
spend approximately $86 million on Y2K, which does not include
capital costs related to replacing non-compliant equipment.
Columbia HCA began planning for the year 2000 in 1996. We
established a year 2000 executive committee and have formed a
multi-disciplinary Y2K support team. This team is monitoring
over 1.4 million medical equipment information systems and
physical plant assets. Our Y2K efforts have included activities
such as contingency planning, coordination with our fiscal
intermediaries, and medical equipment planning.
Medical equipment planning has been, and continues to be,
one of the key areas in our Y2K planning effort. The first
thing we did was an inventory of our medical equipment assets.
With few exceptions, this included anything that had a battery
or power cord. The current medical equipment inventory includes
over 450,000 pieces of equipment.
In an attempt to prioritize our medical equipment and
device planning efforts, we developed a classification system.
This classification system enables us to focus our efforts on
medical equipment that is essential to providing patient care.
The classification has five impact ratings. However, our focus
is mission-critical equipment, which includes life-support
equipment such as ventilators and anesthesia machines.
Next, we identified almost 900 prevalent vendors in the
Columbia HCA medical equipment network. We then surveyed each
of these vendors for compliance information. Ninety-five
percent of those vendors have responded to our request.
Next, vendor responses were evaluated by our survey teams,
subject matter experts, and then risk management experts before
being published in our internal data base. We now have
compliance information on over 28,000 items in this data base,
including 11,000 in the medical equipment category. Our
facilities can now match their equipment inventory back to this
data base to determine if it is compliant or non-compliant.
The final step is facility decisions and remediation. Once
our facility has completed an equipment match to an item to our
internal data base and have identified that the equipment is
non-compliant, they can plan accordingly--to use the equipment
as is, where the Y2K impact does not affect how the equipment
is used in a patient care setting, plan a workaround, consider
an upgrade, replace the equipment, or retire the equipment. The
facility evaluation is based on the equipment classification
and how this equipment is being used in the facility.
Our research and evaluation of medical equipment varied
based upon the equipment's classification. For example,
stricter acceptance criteria from vendors was required for
mission-critical devices. Of approximately 450,000 medical
equipment assets, over 190,000 are mission-critical or impact
level one. We have identified approximately 8 percent of these
as limited or non-compliant and will require remediation. In
addition, we have identified over 800 pieces of mission-
critical or impact level one medical devices which we have
placed in a status of unknown, because the manufacturer has
indicated that they are not evaluating the compliance status of
the devices or for which we have not received acceptable vendor
information. And I might add, that represents 18 companies.
There are several issues we feel might be of particular
significance to the subcommittees, which we have discussed in
our written testimony. They are proof of compliance, the FDA
clearinghouse, hospital medical device testing, and supply
chain issues. We believe that the healthcare providers, the
equipment manufacturers, and the FDA all have responsibilities
in this process. The provider must identify their medical
equipment, obtain the compliance information from the
manufacturer, and then determine if the Y2K impact requires
remediation. The manufacturer should be responsible for
accurately determining the Y2K status of its equipment,
communicate that status, including specific details about what
makes the device compliant or non-compliant to the healthcare
community.
The FDA can support these initiatives by requiring the
manufacturers to determine the compliance status of all of the
equipment, what the impact is, the availability of upgrades,
replacements, or workarounds, and ensuring that there is an
easily accessible mechanism for all healthcare providers to get
the information, including updates. Of special interest is the
need for manufacturers to provide compliance information for
all of their devices, as some have chose not to test obsolete
or retired devices.
Columbia HCA has taken the initiative to manage the year
2000 issue in order to protect the safety of our patients and
to continue providing quality health services. This effort
requires the support and cooperation of public and private
sectors. We appreciate the opportunity to testify today and I
would be happy to answer any questions you have. Thank you.
[The prepared statement of Noel Brown Williams follows:]
Prepared Statement of Noel Brown Williams, Sr. Vice President & Chief
Information Officer, Columbia/HCA Healthcare Corporation
introduction
Good morning Mr. Chairman and Members of the Subcommittees. I am
Noel Williams, Senior Vice President and Chief Information Officer of
Columbia/HCA Healthcare Corporation. I am pleased to appear before you
today on behalf of my company who is a member of the Federation of
American Health Systems. The Federation of American Health Systems
represents nearly 1,700 privately owned and managed community-based
hospitals and health systems that offer traditional acute care,
ambulatory care, rehabilitative care; and allied companies involved in
health care systems.
For purposes of today's hearing, I will specifically discuss
Columbia/HCA's activities and experience concerning Y2K and medical
devices. I will also refer to Columbia/HCA Healthcare Corporation and
it's affiliates as simply Columbia/HCA. Columbia/HCA is one of the
leading health care service companies in the United States. We
currently operate 236 hospitals throughout the country and employ
approximately 225,185 workers, each of whom is committed to the care
and improvement of human life.
Let me begin by thanking you for the dedication and interest you
have shown for the Year 2000 issue. Columbia/HCA recognizes and shares
your concern and I appreciate the opportunity to explain how we, as
representatives of the medical industry, are preparing for Y2K.
Columbia/HCA estimates that we will spend approximately $86 million
on Y2K, which does not include capital costs related to replacing non-
compliant equipment.
columbia/hca's y2k planning effort
Columbia/HCA began planning for the Year 2000 in 1996. We
established a Y2K Executive Committee that includes our CEO and other
senior managers, and we periodically update our Board of Directors on
our progress. In addition, we have formed a multi-disciplinary Y2K
support team made up of physicians and other health care professionals,
information systems (IS), engineering, risk, financial, audit and other
experts to provide guidance, oversight and support for our facilities.
This team is currently monitoring over $1.4 million assets in our
medical equipment, IS infrastructure and facility and physical plant
tracks.
We have also worked closely with other groups and organizations on
the Y2K issue. These include the American Hospital Association and the
Odin Group. The Odin Group is a collection of healthcare-related
companies that include equipment manufacturers, hospitals,
pharmaceuticals, health equipment manufacturers and others involved in
the healthcare process.
Our Y2K efforts have included activities such as contingency
planning, coordination with our fiscal intermediaries, medical
equipment and device planning. I would like to talk briefly about our
activities in the medical equipment and medical device area.
medical equipment planning
Medical equipment planning has been and continues to be one of the
key areas in our Y2K planning effort. Our process for the evaluation
and remediation of medical devices includes the following:
1. Inventory. This involved an inventory of all of our medical
equipment assets. With few exceptions, this included anything
that had a battery, electrical power or power cord. The current
medical equipment inventory includes over 450,000 pieces of
equipment. Our next step in this process was to classify the
equipment.
2. Classification. In an attempt to prioritize our medical equipment
and device planning efforts, we developed a classification
system. This classification system enables us to focus our
efforts on medical equipment that are essential to provide
patient care. The classification system includes mission
critical equipment, which includes life-support equipment such
as ventilators and anesthesia machines, and impact ratings one
through four. The next step in our process was vendor research.
3. Vendor Research. We identified approximately 880 prevalent vendors
in the Columbia/HCA medical equipment network. We then surveyed
each of these vendors for compliance information. I am pleased
to say that 95% of these vendors have responded to our request
for compliance information.
4. Evaluation. After the research component was completed, we analyzed
the survey results using a 3-step process. Vendor responses
were evaluated by our survey teams, subject matter experts and
then risk management experts, before being published in our
internal database. We now have compliance information on over
28,000 items in this database, including 11,000 in the medical
equipment track. Our facilities can now match their equipment
back to this database to determine if it is compliant or non-
compliant.
5. Facility Decisions/Remediate. Once our facilities complete an
equipment match to an item in our internal database and have
identified the equipment that is non-compliant, or has a
limited compliance status, they can plan accordingly. Their
options include:
1) use the equipment ``as is'' where the Y2K impact does not affect how
the equipment is used in a patient care setting,
2) plan a ``workaround'',
3) consider an upgrade,
4) replace the equipment or,
5) retire the equipment. The facility evaluation is based on the
equipment classification and how this equipment is being
used in the facility.
Our research and evaluation of medical equipment varied based on
the equipment's classification. For example, stricter acceptance
criteria from vendors were required for mission critical and impact
level one devices.
Of approximately 450,000 medical equipment assets, over 190,000 are
``mission critical'' or ``impact level one.'' Approximately 92% of
these mission critical or impact level one devices are compliant, while
approximately 8% of these have been identified by us as limited or non-
compliant and will require remediation.
In addition, we have identified 51 models, representing over 800
pieces of mission critical or impact level one medical devices, which
we have placed in a status of ``unknown'' because the manufacturer has
indicated they are not evaluating the compliance status of the devices
or for which we have not received acceptable vendor information.
There are several issues we feel might be of particular
significance to the Subcommittees. I'd like to take a moment to discuss
these with you.
proof of compliance
The General Accounting Office (GAO) has indicated that medical
device manufacturers should provide to the FDA and VHA documentation of
the tests they have conducted on their devices, so they can determine
whether or not the equipment was compliant. As I have previously
stated, we required different levels of information from our
manufacturers, based on the impact level of the equipment.
For mission critical and impact level one medical devices, we asked
the manufacturers for version specific compliance information, as well
as documentation to prove that they had performed testing. We also
required them to provide testing documentation, or testing scripts and
protocols indicating appropriate due diligence was exercised. There are
some obvious advantages in having the FDA manage and standardize such a
process, but unfortunately it is probably too late to initiate this
effort.
fda clearinghouse
Although we understand that the FDA has established a clearinghouse
of medical devices, our approach has been to gather information
directly from the manufacturers. While the clearinghouse provides a
source of information for hospitals, there are areas for enhancement of
the site, which would make it more user friendly. These include
consistency in the presentation of compliance data, a mechanism for
tracking manufacturer's compliance updates or changes and standardized
requirements for compliance information acceptance criteria.
hospital medical device testing
To summarize our process at Columbia/HCA, we begin with a detailed
inventory of our medical devices, including model, version and in some
cases serial number.
Next, we match compliance information from the manufacturer with
the specific device in our inventory. We rely on the manufacturer to be
the authoritative source for compliance information, and have adopted a
testing policy based on the ECRI recommendations that testing should
not be performed by any one other than the manufacturer, except in
cases where insufficient information is available from the
manufacturer.
responsibilities
We believe that the healthcare providers, the equipment
manufacturer and the FDA all have responsibilities in this process. The
provider must identify all their medical equipment, obtain the
compliance information from the manufacturer, and then determine if the
Y2K impact requires remediation. The manufacturer should be responsible
for accurately determining the Y2K status of its equipment and
communicate that status, including specific details about what makes
the device compliant or non-compliant to the healthcare community. The
FDA can support these initiatives by requiring the manufacturers to
determine the compliance status of all of their equipment, what the
impact is, the availability of upgrades, replacements or workarounds,
and ensuring that there is an easily accessible mechanism for all
healthcare providers to get the information, including updates.
Of special interest is the need for manufacturers to provide
compliance information for all of their devices, as some have chosen
not to test obsolete or retired devices.
supply chain issues
There are several supply chain issues related to medical equipment.
These are:
1) availability of upgrades and service personnel to fix the non
compliant equipment, and
2) availability of disposable supply items and reagents that are
required for operating the medical devices.
Hoarding of hospital supplies has recently become a concern in the
industry. We are working closely with our peers, the American Hospital
Association, our suppliers and distributors to evaluate the supply
chain and put safeguards in place to ensure uninterrupted supply
availability. In our opinion, hoarding or stockpiling of additional
supplies could create shortages well ahead of the Year 2000 transition.
We encourage all parties to work collaboratively on this critical
issue.
conclusion
Columbia/HCA is taking the initiative to manage the Year 2000 issue
in order to protect the safety of our patients and to continue
providing quality health services.
There are serious challenges ahead of us, but we are confident that
the healthcare industry will meet these challenges. This effort
requires the support and cooperation of both public and private
sectors. We appreciate the opportunity to testify today and welcome any
questions you may have at this time. Thank you.
Mr. Upton. Thank you.
Mr. Nunn.
TESTIMONY OF JOHN C. NUNN
Mr. Nunn. Good afternoon. I am John Nunn, vice president
for Patient Care Services at Henry Ford Hospital, part of the
Henry Ford Health System in Detroit. I also co-chair the
Systems Y2K Contingency Planning Committee. I am here on behalf
of the American Hospital Association's 5,000 hospitals, health
system networks, and other providers of care.
Most of the Nation's hospitals expect to be Y2K compliant
by January 1, 2000, based on the results of the nationally
representative AHA survey. Of the remainder, almost all expect
to be sufficiently prepared that critical operations will not
be affected. Approximately 2,000 hospitals responded to the AHA
survey which was conducted in February: 5.7 percent of the
hospitals said that their medical devices were compliant, 90.4
percent expected their devices to be compliant by the year end
or expected no problems in their operations, and only .5
percent expected compliance with possible adverse effects.
Henry Ford Health System is in the middle category. Our
devices are not 100 percent compliant, but like the great
majority of hospitals, we expect no problems as a result. Put
another way, all of our devices may not be compliant, but our
hospitals themselves will be.
At Henry Ford we have about 25,000 medical equipment
devices; we have completed the Y2K assessment in all but 7,800.
Those are held up largely because the communication process
between us and the manufacturers is ongoing. Some cases,
especially in older devices, simpler devices, or where
manufacturers are out of business or merged and no longer
servicing their devices, we are having difficulty getting
devices declared or certified compliant.
Of the items we have assessed, only about 3 percent, or
about 500 devices, required action. Of those, 60 percent
required a software upgrade; 20 percent will be subject to what
we call a workaround, which means that staff can work around
the problem without modification of the device; 18 percent of
the equipment will need to be replaced. Remediation is required
if the two-digit date in the medical device's computer chip is
used in a calculation, archiving or sent to another computer.
The decision to upgrade or replace the device depends on
availability and cost. If the data is not critical used in one
of these calculations, the workaround solution may be used.
For example, we are replacing or upgrading some of our EKG
machines because they report to a central reporting computer.
We will upgrade that equipment. Our standalone EKG equipment,
on the other hand, may show the wrong date and be technically
not compliant, but we will work around by striking that date,
writing in the correct date on the report, and signing the
correct date.
Most devices that we still need information on are not
critical care or the life support area. We have machines in our
labs that mix--shake blood samples, for example; it monitors
other equipment that do not have a safety hazard associated
with them. While we are convinced that many of these devices
which are electric will not be affected, until we hear from the
manufacturer, we are hesitant to declare them compliant. As
January 1 approaches, we will make those decisions and are
prepared to move ahead without manufacturer information.
We do rely heavily on the manufacturer testing and
information, and the information we have been receiving appears
to be reliable. As the new year approaches, if we cannot get
the information we need, we will have four options: Try to do
limited testing ourselves; hire a third-party tester; wait
until the date change and then recalibrate the device to make
sure it works, using our normal QC processes, or ultimately
retire or replace specific devices.
No matter how hard we prepare, surprises happen.
Fortunately, hospitals are experienced in and ready for
surprises. Whether it is Oklahoma, Kansas, Colorado, Georgia,
forces of nature, failures of man, hospitals expect the
unexpected. Last summer a construction company dug through our
hospital's main power line. Ultimately, we lost two-thirds of
the power to our hospital, and we were able to manage that
situation without harm to our patients.
I note that my time is up and am just entering my
conclusion. Of course, Y2K could be different, but then, again,
we plan for the unexpected. Y2K is not unexpected. It is
something that we know will happen; it is at a known time in a
controlled environment. We have identified the contingencies we
need to prepare for and are preparing for them. I believe the
hospitals and the health systems will succeed because of the
people inside of them. Emergency department personnel to the
CEO do this type of work and are prepared to make the decisions
that will be required.
I would be glad to answer any questions.
[The prepared statement of John C. Nunn follows:]
Prepared Statement of John C. Nunn, Vice President for Patient Care
Services, Henry Ford Hospital on Behalf of the American Hospital
Association
Mr. Chairman, I am John C. Nunn, vice president for patient care
services at Henry Ford Hospital, part of the Henry Ford Health System
in Detroit. I am here on behalf of the American Hospital Association's
(AHA) nearly 5,000 hospitals, health systems, networks, and other
providers of care.
The AHA and its members are committed to continuing the smooth
delivery of high-quality health care, at the turn of the century and
beyond, uninterrupted by the calendar change that will occur at
midnight December 31. We appreciate this opportunity to update you on
our efforts, to outline the role that the AHA has taken in aiding the
health care field, and to focus on what hospitals are experiencing as
they work to assure themselves, their patients, and their communities
that the medical devices and equipment they rely on will operate
safely.
progress on y2k compliance
The majority of the nation's hospitals expect to be completely
``Y2K compliant'' by January 1, 2000, based on the results of a
nationally representative survey we conducted. Of the balance, almost
all expect to be sufficiently prepared that critical operations will
not be affected. The survey occurred in February 1999, and medical
device readiness was one of the focuses. Respondents represented not-
for-profit and investor-owned hospitals in urban and rural areas.
Following are highlights from the medical devices portion of the
survey:
<bullet> 5.7% of hospitals said their devices were compliant when they
responded in February.
<bullet> Another 90.4% of hospitals expected their devices to be Y2K
compliant by year end or expected no problems in their
operations.
<bullet> 0.5% expected non-compliance with possible adverse effects.
In the survey, hospitals were asked whether their medical devices
would be compliant, or noncompliant with no adverse effects. This is
important, because some medical devices could technically be labeled
non-compliant, even though they will not fail to operate as a result of
the date change.
For example, an EKG machine may provide accurate heart rate
information, while the strip recording the test information notes the
date of the test incorrectly. In such cases, medical personnel would
simply write the correct date onto the readout. In no way would this
machine be a danger, but it technically would be labeled non-compliant
because it did not recognize the date change.
how hospitals are preparing
In general, hospitals have been taking the following steps to
ensure the safety and reliability of their medical devices at the turn
of the century:
<bullet> Taking inventory of all equipment and devices--identifying
which may be potentially affected by Y2K.
<bullet> Determining which are actually affected and how their
functioning will be altered--this is done through contact with
the manufacturers to get the results of their assessments and
testing.
<bullet> Taking follow-up action if those devices or equipment are
affected by Y2K--depending on the device or equipment, this may
mean repairing, taking out of service, or training staff on how
to use the equipment going into the new year.
<bullet> Developing contingency plans--even with all the advance
preparations. Hospitals still need to anticipate the
unforeseen.
contingency planning
America's hospitals and health systems are in the business of
dealing with the unexpected. They are used to mobilizing quickly in the
face of floods, hurricanes and potentially disastrous events that are
an unfortunate fact of life. There is no reason to believe that they
will not also be ready for the Year 2000, whether or not every medical
device in the hospital is Y2K-compliant.
Patient safety is the highest priority for hospitals and health
systems. Our ultimate contingency plan is to take care of patients at
the bedside--as we do 24 hours a day, seven days a week, 365 days a
year. Should a medical device turn out to be non-compliant, it is very
likely that the ramifications will be limited, because it is a
hospital's people who take care of patients, not a hospital's medical
devices.
Hospitals are examining a range of options, such as having extra
staff available for the date change and for the few days after, and not
scheduling elective surgeries, thus ensuring that only people who
absolutely need to be in the hospital are there.
This is not being done out of a sense of panic, but to provide the
broadest latitude for dealing with the unexpected. Some devices and
equipment can only be operated in real-time--that is, after the clock
turns from Dec. 31 to Jan. 1--and hospital personnel will literally
watch this equipment's clock change to ensure that it works properly
before allowing it to be used for patient care. The ultimate
contingency plan is to provide care the old-fashioned way in the
unlikely case of a modern medical device impeding care.
Some outside factors could also have an indirect effect on how our
people deliver care. Specifically, it is incumbent upon hospitals to
prepare now to respond to the potential loss or disruption of any
essential hospital processes or services, and our survey indicates that
our members are doing just that. They are directing their efforts both
internally across hospitals' facilities, and externally within
communities. This includes working with such entities as utility
companies, emergency medical services, and other health care providers.
According to the AHA's survey, 66 percent of hospitals have
initiated contact with utilities in their area; 44 percent have
initiated contact with other hospitals; 38 percent have initiated
contact with fire and police authorities; 36 percent have initiated
contact with ambulance services; and 35 percent have initiated contact
with their local governments.
relying on manufacturers
Hospitals have historically relied on manufacturers'
representations of the fitness and safety of their products. There is a
sound reason for this: Manufacturers are in the best position to
analyze and test their products, and they have a regulatory obligation
to do so. Absent some bona fide basis for believing that a
manufacturer's compliance statement is inaccurate, hospitals need to
rely on the longstanding presumption that manufacturers are acting in
good faith and issuing information backed up by proper analysis and
research.
The FDA's Y2K guidance to manufacturers emphasizes the
responsibility of manufacturers for their products' Y2K compliance and
safety. FDA has stressed that the technical know-how for determining
the compliance status of devices rests with the manufacturers.
A complex question that hospitals face is whether to undertake
independent testing of their medical devices and equipment. This is a
decision that ultimately must be made using the judgement of the
leaders of each individual hospital or health system.
ECRI, an international nonprofit health services agency that is
recognized as the ``Consumer Reports'' for biomedical devices, recently
published its position recommending how health care organizations
should address the Y2K medical device testing issue. At AHA's request,
this position statement was reviewed and discussed by a number of
health care systems and biomedical manufacturers. Considerations for
evaluating the thoroughness of a manufacturer's compliance disclosure
statement also were discussed. The AHA has made the ECRI paper
available on the AHA Web site and issued a companion advisory.
The ECRI statement cautions that a program of testing is not a
panacea for health care providers. Rather, ECRI recommends that health
care facilities address the Y2K medical device problem in the following
way:
<bullet> Obtain manufacturer information regarding Y2K compliance
status of any susceptible medical devices in their inventories
either directly from the manufacturer or through the Food and
Drug Administration (FDA) or a commercial data base.
<bullet> If a facility has received complete compliance information for
a device, testing of that device by the health care institution
is not necessary.
<bullet> If clear and complete information on a device's Y2K compliance
status cannot be obtained, the facility should perform Y2K
testing or take other appropriate action.
The ECRI position identifies reasons why health care institutions
should proceed cautiously when considering a testing program, including
the lack of expertise and information at most institutions to perform
an adequate level of testing. ECRI argues, in fact, that the testing a
provider can accomplish is superficial and may provide false assurances
about compliance and introduce a wholly different set of problems.
Although a few hospitals have identified discrepancies between what
some manufacturers have reported and their own tests of medical
equipment. ECRI believes that the total number of these occurrences is
extremely small and none are mission critical.
The ECRI position separately addresses situations in which testing
is warranted: devices that are interfaced as a system, those with
replacement parts, and those user-modified.
the role of the fda
The AHA, as part of the National Patient Safety Partnership, has
been collaborating with the FDA to ensure that its Federal Year 2000
Biomedical Equipment Clearinghouse is receiving accurate and useful
information from manufacturers. This information, easily available on
the agency's Web site at www.fda.gov, has been improved significantly.
As the General Accounting Office recently testified before these
subcommittees, ``In collaboration with the National Patient Safety
Partnership, FDA is in the process of obtaining more detailed
information from manufacturers on noncompliant products, such as make
and model and descriptions of the impact of the Y2K problem on products
left uncorrected. For example, FDA sent a March 29, 1999, letter
requesting that medical device manufacturers submit to the
clearinghouse a complete list of individual product models that are Y2K
compliant.''
It is critical that the FDA continue to closely monitor the
reporting of manufacturers about their medical devices and equipment.
FDA has the expertise, the resources, and the authority to ensure that
products are safe and reliable.
At the same time, we believe that the FDA should play a ``rumor
control'' role, monitoring such arenas as the Internet and the media to
make sure that information that circulates about the effects of Y2K on
medical devices and equipment is accurate, and correcting it when it is
wrong.
y2k liability
Hospitals cannot meet the Y2K challenge alone. We depend not only
on medical device manufacturers, but also on vendors and suppliers,
software companies, even the companies that maintain the elevators we
use to transport patients, to name a few. Hospitals have made hundreds
of thousands of contacts through letters and phone calls to learn
whether manufacturers' and vendors' products are Y2K compliant and, if
not, what modifications may be necessary to bring them into compliance.
In most cases, hospitals depend on manufacturers and vendors for
information and support; hospitals cannot make the changes themselves.
Unless hospitals are provided the necessary information, they will not
be able to take appropriate action, including the development of
responsible contingency plans. Vendors and manufacturers must take the
initiative for several reasons. From a legal perspective, license
agreements, warranties and other protections will be at risk if the
hospital takes action on its own. From a practical perspective, only
the vendors and manufacturers have the know-how needed to make
technical evaluations and recommendations.
In spite of all that is being done, some problems may still arise.
The AHA and its member hospitals understand and appreciate the desire
to avoid litigation. Dollars diverted from the delivery of health care
are dollars lost to the mission of hospitals. In considering any
proposal for Y2K liability reform, hospitals and health systems have
one overriding concern: that their ability to deliver high quality care
will not be hurt in any way.
We want to ensure that hospitals remain on a level playing field
when defending personal injury cases. Hospitals must retain all of
their current rights to take legal action against a vendor or
manufacturer whose product is involved in a claim. While we believe
that the legislative proposals do not intend to create a disadvantage
for hospitals, it is essential that, if a hospital is sued by a patient
for a Y2K related event, explicit language be included in any proposal
to ensure that the hospital has the same recourse against a vendor or
manufacturer as it has today. H.R. 775, recently passed by the House
does this. We are working to assure that the Senate includes a similar
provision in their Y2K legislation.
the role of the aha and other associations
Mr. Chairman, all of the activities I've described above are part
of an overall effort by the AHA and its state associations to help
hospitals and health systems in their Y2K preparation. This effort
includes:
<bullet> Working with state hospital associations to sponsor Security
Third Millennium (SIIIM), an Internet tool helping health care
providers get information to minimize malfunction or failure of
biomedical devices and equipment on January 1, 2000;
<bullet> Developing a members-only Y2K section of AHA's Web site with
up-to-date news and resources to help manage the Y2K computer
challenge;
<bullet> Using a toll-free 800 number to provide Y2K information to
members on educational opportunities, peer and consultant
referrals and speaker recommendations;
<bullet> Creating the ``Y2K: Mission Critical'' executive briefing, a
notebook for hospitals that outlines the Y2K problem and offers
information on how to deal with it;
<bullet> Using AHA's publications to provide members with information,
including ``The Clock's Ticking'' column, devoted entirely to
Y2K, in AHA's weekly newspaper;
<bullet> Developing the members-only ``Y2K Communications Action Kit,''
a resource with tools to help communicate a hospital's Y2K
progress with the public; and
<bullet> Distributing a contingency planning workbook with templates to
help hospitals create internal and external back up plans.
The AHA, along with state, regional and metropolitan hospital and
health system associations, is also working hard to make sure that
America's hospitals and health systems are informed about, educated on,
and assisted with Year 2000 contingency planning. We recently
distributed to every AHA member a briefing on hospital contingency
planning. This briefing emphasizes the interdependent nature of health
care, and stresses the need for hospitals to plan in advance, with
their key partners, how they will handle potential Y2K-induced losses
or disruptions. This executive briefing was followed up by ``how-to''
materials for hospital contingency planning, including a business
continuity planning guide.
In addition, the AHA will be working with the Federal Emergency
Management Administration to coordinate emergency preparedness efforts
at a national level with contingency planning taking place at
individual hospitals in local communities. We recently brought together
representatives of major health systems and health care manufacturing
and supply companies to discuss how we can provide guidance to the
health care field on issues related to Y2K preparedness and concerns
about health care equipment and pharmaceutical and medical supply
stockpiling. We are also participating in the President's Y2K Council's
roundtables on the issue of stockpiling.
the role of congress
As I have described, health care providers and the associations
that represent them are devoting significant time, resources and energy
to preventing potential Year 2000 problems from affecting patient
safety. It is essential that we all look for ways to help prepare
America's health care system for the turn of the century, and Congress
can play an important role. Your attention to this issue, through
hearings such as this, reflects your understanding of the gravity of
the situation.
One major step toward Y2K compliance occurred when Congress passed
its ``Good Samaritan'' legislation. By shielding from liability the
sharing of information among businesses that provide it in good faith,
this law encourages all parties--providers, suppliers, manufacturers,
and more--to work together.
We ask you to help America's health care system avoid Year 2000
problems by taking several other steps:
<bullet> Congress should provide the FDA with any additional authority
or resources it needs to ensure the necessary information is
disclosed by medical device manufacturers, and to serve a
``rumor control'' function regarding devices.
<bullet> Recently, John Koskinen, chairman of the President's Council
on Year 2000 Conversion, mentioned the possibility of creating
a contingency fund from which states (in the case of Medicaid,
for example) or hospitals could draw monies needed to continue
operating in case of a Y2K disruption. We support that
principle, and would be glad to be a part of any discussions
concerning how such a fund should be set up.
<bullet> MedPAC has included in its hospital prospective payment system
update recommendation for fiscal year 2000 an additional 0.5
percent to cover hospitals' costs of becoming Y2K compliant. We
ask Congress to increase the congressionally mandated hospital
update factor by 0.5 percent to reflect this MedPAC
recommendation.
conclusion
America's hospitals and health systems, their state associations,
and the AHA are partners in the effort to prepare for the Year 2000. We
believe that most manufacturers are being forthcoming and complete in
their assessments of the medical devices they provide to hospitals. We
look forward to continuing our work with you, the FDA, and medical
device manufacturers in ensuring a smooth--and healthy--transition into
the new millennium.
Mr. Upton. Thank you very much.
I will recognize first the vice chair to the subcommittee,
Mr. Burr, for 5 minutes.
Mr. Burr. Thank you, Mr. Chairman.
Mr. Smith, let me commend HIMA for I think going above and
beyond what associations are set up, but with Y2K we have got
somewhat of a circumstance we have never been faced with
before. I think it is wise for the association to engage to the
degree that they have, and I am hopeful that will be in a form
of a partnership as well, but the Federal Government will do
equally their share.
Let me just ask you, going back to this point where we
begin to panic, if in fact we have a product in the marketplace
that is non-compliant, can the manufacturers handle some type
of recall in 90 days?
Mr. Smith. As I listened to that earlier discourse, I was
struck with the fact that perhaps one manufacturer could handle
a recall in 90 days. I am not so sure that many, many multiple
manufacturers could handle the recourse in that case.
Mr. Burr. And the fact is that we don't know whether we
will have any problems, or whether we will have 10 problems, or
whether we will have 100 problems. Is that a pretty safe
assumption right now?
Mr. Smith. It is a safe assumption that we don't know that.
I think it is a safe assumption as well that we are all working
to mitigate those problems such that we have many fewer than
most.
Mr. Burr. And I think----
Mr. Smith. I would like to add one more thing--I am sorry.
Mr. Burr. Yes, sir.
Mr. Smith. And that is that I think we have lost, to some
degree, the ideology that, as the year 2000 gets closer, there
is much more focus and effort put on trying to solve issues
associated with the year 2000. It is very common-sensible to me
that a year ago, having not been as focused on the problem, we
see things in a certain way. A year later, 6 months later, the
dynamic nature of this, we are making tremendous strides, I
think, maybe exponential strides, to continue to address
things. I think that is true throughout the healthcare arena,
by the way.
Mr. Burr. I think one of the responsibilities of this
committee is to instill the same sense of urgency----
Mr. Smith. I agree.
Mr. Burr. [continuing] in all areas of the Federal
Government.
Let me ask you, Ms. Williams, who do you think as far as
Federal agencies has the oversight over this issue as it
relates to hospitals? Who would you expect to contact you
relative to Y2K-compliance issues from the Federal Government?
Ms. Williams. Probably the FDA. Possibly the HCFA, but
primarily FDA.
Mr. Burr. Mr. Nunn?
Mr. Nunn. I think that the best source of communication
will come from the manufacturer. The most effective source, if
we do get communicative from the government, I think it is the
FDA.
Mr. Burr. Do you see the FDA by design or just because
nobody else wants to deal with it as the oversight agency?
Mr. Nunn. Yes.
Mr. Burr. It wasn't a yes or no, but I will take it by
design.
I ask those specifically for Dr. Shope, because he is here,
interested enough to stay, and I think it is important that
they understand how hospitals look at FDA's role relative to
the Y2K, when they go back and try to answer some of these
questions.
Ms. Williams, for a hospital that has not done what
Columbia has done, gone through, looked at the number of items,
looked at contacting manufacturers, and asked for proof of
compliance to determine how many potential problems you may
have in your facilities, let us assume that today they got that
sense of urgency; can they go through the process that Columbia
has between now and January 1, 2000?
Ms. Williams. I would say it would depend on the size of
the hospital. I mean, if they had a very focused effort. But
again, it is going to depend on the size of the hospital, the
number of----
Mr. Burr. You said for Columbia you started working in
1996, or at least you began to identify the problems in 1996.
Is it realistic that there is a hospital that has the
capabilities in a 7-month period now to actually go through and
evaluate all their devices?
Ms. Williams. I would say it would be difficult, but if
they applied proper resources and, you know, very focused
efforts.
Mr. Burr. The smaller the hospital, the fewer the
resources; the larger the hospital, the more the resources, but
larger hospitals also have more equipment.
Ms. Williams. It would be difficult.
Mr. Burr. Okay. Let me ask you about the FDA clearinghouse
real quick, because you made some statements, ``although we
understand the FDA has established a clearinghouse of medical
devices.'' That statement leads me to believe that you haven't
even looked at the website.
Ms. Williams. We have looked at it. We do not rely on it as
our primary resource. We rely on the manufacturers.
Mr. Burr. Have you used it in any way as a resource?
Ms. Williams. Not as a primary resource. We have looked at
it.
Mr. Burr. Have you used it as a secondary resource other
than to just look at it? I would like you to be as honest as
you can, because I think there is a tremendous reliance at the
FDA on the clearinghouse as a search, and if it is not
something that hospitals--I say that in a broad way--are
utilizing today, I think it is important that we point it out
to the FDA, so that they can plan accordingly.
Ms. Williams. As I said, we rely primarily on the
manufacturers, and our primary use of the FDA website is for
addresses of the manufacturers, and so forth.
Mr. Burr. Mr. Nunn, would you like to comment?
Mr. Nunn. We have used the FDA website. Talking to our
clinical engineers, they do use it as an information source.
They also like that you can click into the manufacturer data
bases when you are in and researching particular information.
Mr. Burr. If you identified something through the
clearinghouse, is the likelihood that you would stop there if
it expressed some concern, or would you then contact
manufacturer?
Mr. Nunn. No, we are working directly with the
manufacturers. We consider them to be our prime source of
information.
Mr. Burr. So it is not a one-stop shop?
Mr. Nunn. That is correct.
Mr. Burr. I see that my time has run out. Let me just thank
all three of our panelists today. I can ensure you that it is
our intent to serve as a facilitator in making sure that sense
of urgency, but also that the resources are available for that
partnership between the private sector and the Federal
Government. So that everybody can have the assurance, not just
the size of Columbia, or your facility, Mr. Nunn, but also
right down the rural health clinics that many of us have
throughout our districts.
With that, Mr. Chairman, I yield back.
Mr. Upton. Thanks. The Chair recognizes Mr. Klink.
Mr. Klink. Thank you, Mr. Chairman.
Let me ask each of you, the GAO has argued that the FDA
should not necessarily rely on medical device manufacturers'
certification of Y2K compliance. Instead, the GAO has advocated
the FDA itself certify such testing has been completed and then
review the results themselves. So my question is, do you think
that the manufacturers' certificate certifying Y2K compliance
is enough or is it trustworthy, or do you think the FDA needs
to go behind such certification and review the data itself? Let
me start with you, Mr. Smith.
Mr. Smith. From my perspective, I believe we have been
doing this all along from an industry perspective for many
years prior to Y2K. And therefore, I think the information that
is there is sufficient and should be sufficient. I think the
GAO request to go beyond that on behalf of Y2K, quite frankly,
is another intervening step. I understand their concern, but at
the same time I think there is a process in place that has been
in place for a long time that has met both the industry's needs
and, more importantly, met the needs of patients during that
time as well.
Mr. Klink. Thank you. Ms. Williams.
Ms. Williams. We agree with that.
Mr. Klink. Mr. Nunn.
Mr. Nunn. Yes, I agree with that.
Mr. Klink. You concur?
Is there a role that all--let me go back and ask each of
you and maybe start with you, Mr. Nunn. Do you see a role for
the FDA in reviewing any of these compliance certificates? What
role would you think the FDA should have?
Mr. Nunn. I agree with Dr. Shope that the FDA's role is in
the assurance that their process is appropriate rather than
individually looking at equipment. And if there is some
specific equipment, in terms of high-risk equipment, that it is
felt that an additional level of diligence is required, I would
be supportive of that.
Mr. Klink. Ms. Williams, you concur? Mr. Smith?
Mr. Smith. I would agree with Dr. Shope's comments that the
issue is probably the critical items in that--again, while I
don't think it is necessarily based on the process that goes
on, the 60 categories that he referenced being critical, et
cetera, if the FDA feels that is where they should go from a
HIMA perspective, and certainly from a Baxter perspective, we
would be very supportive of that.
Mr. Klink. Ms. Williams, what particular types of equipment
do you think, at the present time, we should be most concerned
about regarding Y2K compliance?
Ms. Williams. I have my colleague, Don Workman, here with
me who is very technically oriented in this regard. Might I
defer that question to him?
Mr. Klink. Mr. Chairman, is that fine?
Mr. Upton. Sure.
Mr. Klink. Pull a chair up, sir. Welcome to the committee.
Mr. Workman. Kind of like Thanksgiving.
Mr. Klink. If you are the turkey, right?
Invited to a party.
Mr. Workman. If I understood the question or heard it
correctly, what types of devices should we be concerned about?
Mr. Klink. Yes, what devices should we be most concerned
about concerning Y2K compliance?
Mr. Workman. We have a classification system that has
categorized approximately 700 medical device categories. We are
focused on the mission-critical in level one. These are devices
that would have some sort of impact on patient safety or
patient care--either deliver care to a patient; they are
electrically charged in some way, shape, or fashion, or a
failure of these devices would impact patient safety or
business continuity.
Mr. Klink. Does anyone else, Mr. Smith or Mr. Nunn, have
anything to add to that?
Mr. Nunn. No.
Mr. Smith. No.
Mr. Klink. You concur?
The GAO mentions in their testimony some hospitals have had
their own in-house compliance engineers test biomedical
equipment that they believe is the most susceptible to the Y2K
bug. These hospitals reportedly told GAO that this was proper
due diligence regarding Y2K testing. This seems to imply that
hospitals not doing this type of in-house testing are somehow
being negligent with regard to the public's health and safety.
Do you believe that every user of a biomedical device should be
doing their own testing? In other words, is there a certain
group of providers such as hospitals that should be doing their
own in-house testing?
I will start with you, Mr. Smith.
Mr. Smith. I think, as I mentioned earlier Congressman, I
don't think they do. I think the process is in place, and has
been in place for quite a while for medical device
manufacturers, per the FDA, to meet those standards. We follow
good manufacturing practices; we have for a long time, and I
think this has become an issue simply because we are dealing
with the year 2000. Left to our own device, this would be going
on as it has many years prior to this.
Mr. Klink. Ms. Williams.
Ms. Williams. We agree with that.
Mr. Klink. You don't have your own in-house biomedical
engineers at Columbia?
Ms. Williams. We do, but we are not----
Mr. Klink, Can you pull the microphone over a little bit?
Ms. Williams. We do have biomedical engineers, but we are
not testing every piece of equipment ourselves. We are relying
on the information that we got from the manufacturers.
We visited a number of manufacturers in order to understand
the information that they are providing to us that we asked for
their testing protocols when we did this compliance survey. So,
we are, with the exception of those 800 pieces of equipment
that we don't have answers on, we continue to try to get
answers on that equipment, and if we don't, then we will make a
determination what level of testing we need to do there. But,
otherwise, we are relying on the manufacturer.
Mr. Klink. Can you tell me how you determine what it is you
test and how that is decided?
Ms. Williams. We have relied upon the manufacturers and an
understanding of their testing protocols. The 800 pieces of
equipment that we have not received information on we continue
to try to go back to the manufacturer and receive information.
If we don't, probably in the third quarter we will determine
what level of testing we need to do on that equipment based
upon the impact of the equipment on patient care.
Mr. Klink. Let us forget about Y2K for 1 second. I assume
that you didn't just hire these biotechnical engineers because
the year 2000 is coming up; they work for you?
Ms. Williams. Right.
Mr. Klink. At other times, how would you determine what you
would have them test?
Ms. Williams. I need to defer that to----
Mr. Klink. That is fine. Do they test everything that comes
in or there is certain protocol as to what equipment they test?
Mr. Workman. No, sir. When the manufacturers come in and do
software upgrades or bring in new pieces of equipment, we
depend on the manufacturer to certify that that equipment is
ready for patient safety or patient care.
Mr. Klink. Then, how do you determine what it is your
people are going to test?
Mr. Workman. We are following the ECRI guidelines. ECRI is
a sort of the Consumer Reports for medical device testing. They
came out with a position that said that, in the absence of
adequate manufacturers' compliance information, a limited
testing strategy should be put in place. Our program is focused
on mission-critical and level one and we are going to follow a
three-step process. Originally, we would hope that the original
equipment manufacturer would test for us. If we are unable to
do that, we are going to bring in an authorized service
provider for that manufacturer, and if we can't get to that
level, then we signed a contract with General Electric for
their biomedical folks to come in and help test devices for us.
Mr. Klink. What does this say about the hospitals that are
not doing this testing? Do they count on hospitals the size of
Columbia to do this kind of testing? And is this information
shared with other hospitals? And if other hospitals are doing
tests, is that made available to you?
Mr. Workman. I am not aware of a source for that type of
information.
Mr. Klink. Well, let me go back to the first part of my
question. Does this make any statement about other hospitals
that don't have the biotechnical engineers or biomedical
engineers on staff, and aren't able to do the kind of testing
that you do? I don't want to put you in a bad place; it just
raises a question to me.
Mr. Workman. I can express a personal opinion. I think some
of those hospitals are going to have some problems meeting the
deadline, given the 7 months that are left.
Mr. Klink. Thank you very much.
Mr. Chairman, I see the red light is on also.
Mr. Upton. Thank you.
Mr. Smith, first of all, I want to commend the work of
HIMA, and with your testimony, congratulations certainly are
deserved as you look at 100 percent compliance with your
association and your ability to reach out. I think that is
really terrific, and I want to thank you for that.
Mr. Smith. Thank you.
Mr. Upton. You know, as I think about my own congressional
district, it is really a lot--it is a microcosm, I think, of
the real Nation in terms of a blend between urban and rural. We
have got small hospitals and larger ones like Bronson and
Borges, which I certainly know, Mr. Nunn, you are familiar
with. There has been a lot of association work, a lot of
communication between the hospitals, whether they are
affiliated or not, in terms of how to comply with a number of
different things.
Do you feel that the State associations have done a pretty
good job, and what relationship has Henry Ford had with some of
the hospitals that it has on the other side of the State from
me?
Mr. Nunn. We have been in communication with the State
associations. There has been work on the issue and education
around the issue, those kinds of things. We have met with
hospital groups. In fact, we are meeting next week with a group
of hospitals in the metropolitan Detroit area on this issue.
Ultimately, though, I believe when it comes down to your
devices and what your plans are for your devices, it becomes
much more focused on the issues as they have been discussed
here today, which is communication between the manufacturers,
potentially FDA, and yourself, and what your plans are for your
devices.
I think there has been, though, from what I can see, and in
my discussions with our people who are involved in this,
extensive communications with people outside of our hospital
and other hospitals, whether it is trade groups, associations,
at conventions. This has been on the agendas at conventions to
be talking about it. So I think that communication has been
there, but it won't drive the answer, which I think is between
us and manufacturers.
Mr. Upton. Do you think that the hospitals have had some
feeling that they have had to reinvent the wheel, or do you
think because of the association and the cooperation with other
hospitals, whether they be in the region or system that they
might be affiliated with, that it has been a pretty good
relationship?
Mr. Nunn. I think it has been a good relationship. It
certainly was not our intention to reinvent the wheel, but to
use the information that was out there and bring it into our
organization and have it work for us. I think the information
is there for people to do that.
Mr. Upton. Ms. Williams.
Ms. Williams. We have worked actively with the federation
members as well as the American Hospital Association and
another group called ODEN, which is a research and advisory
group dedicated to healthcare technology issues. Members of
that group are equipment manufacturers, pharmaceutical
companies, payers, and other providers, and we have worked
within that group across the industry on the medical device
issues as well as contingency planning. So we have been active
in a lot of groups in terms of information-sharing and
coordinated planning.
Mr. Upton. You know, one of the questions that I have asked
a number of my folks back home as they prepare for Y2K, they
always seem to say we think we are going to be okay as long the
power stays on or, you know, a variety of other units have made
their successful effort. There has been talk about hoarding of
supplies. You see that in the news media as well. Have the
hospitals made any real effort, do you think, to hoard supplies
in fear that the supply train may have some problem beginning
January 1?
Mr. Nunn. Our pharmacy is working with the other pharmacy
departments at other hospitals around the Detroit area, in
conjunction with the manufacturers in the supply chain, to
ensure that there is not a disruption in the supply chain for
pharmaceuticals, because pharmaceuticals, in particular, the
supply chain is long. If there is hoarding, there could be a
problem. So we are working with the appropriate people to
prevent that from happening. So I think there is recognition of
the supply chain issues, and work is going on in those.
I think that one of the areas that support can be given is
in helping manage the rumors and not having a panic situation
going into the fourth quarter. If the public is convinced that
the sky is falling, it will be very difficult, and there will
be hoarding going on, and I think accurate information being
distributed so that we are not a society in panic would be very
helpful in this regard.
Mr. Upton. Thank you. My light is on and I will recognize
the chairman of Health and Environment, Mr. Bilirakis.
Mr. Bilirakis. Thank you, Mr. Chairman.
I did want to put into record that Dr. Shope is here to
hear your testimony, and I think that is always very helpful.
We appreciate your staying, Doctor.
Well, let us see, Baxter, your company is a global
company----
Mr. Smith. Yes.
Mr. Bilirakis. [continuing] and you have shared with us
some apparently good work that your company is doing regarding
addressing this issue. But you do business, as I understand it,
in over 100 countries?
Mr. Smith. We do.
Mr. Bilirakis. Yes, all right, and I don't want you to give
me any details, but would you say that you are basically being
prepared or are prepared insofar as the global is concerned?
Mr. Smith. We have taken the same process in the other
countries we have taken in the United States, which is from a
business contingency plan perspective. We have gone out and
contacted our customers and contacted all the elements, if you
will, associated with making sure that we can provide
consistent supply of products in that country. That could be
something as broad as talking with the customs folks to making
sure that the import/export activities don't go down as a
result of a Y2K problem, or something as small as looking at a
particular product that we only sell in that particular
country.
Mr. Bilirakis. Well, how about a medical device that is
manufactured in one of these other countries. I suppose maybe
we could have asked FDA that, but in terms of, you know, their
cooperation, compliance, and things of that nature, what can we
anticipate there?
Mr. Smith. From a Baxter----
Mr. Bilirakis. And I really don't know off the top of my
head what device I could be referring to, but I would assume
there are some out there that have been approved that are being
used by Americans but manufactured elsewhere.
Mr. Smith. I probably would defer that question to Dr.
Shope, because I think he is probably better suited to answer
it. From a Baxter perspective, those plants outside the United
States where we do make medical devices fall into the same
provisions as plants that we manage within the United States.
So we run them just the same way.
Mr. Bilirakis. You run them?
Mr. Smith. Meaning we follow the same manufacturing
practices.
Mr. Bilirakis. If they are your plants, but if they are not
your plants?
Ms. Williams, I know that, and I am not just referring to
Columbia, but a lot of hospitals around the country, certainly
many in my area, are having problems these days. What BPA 97
did to them--I know Herb Katz would want me to make that
comment. And you know, in other words, they are having some
problems. So, I know that this is an additional load, because
obviously there is going to be some finances involved here.
With all that Columbia apparently has done, I think you
have said that it has been done in cooperation with the
American Hospital Association and with other groups. Is that
right?
Ms. Williams. Right. That is right.
Mr. Bilirakis. Well, Mr. Nunn, you said that while all of
your devices--I don't know that I am quoting you correctly--may
not be compliant in your hospitals, but all of your hospitals
will be, or words to that effect.
Mr. Nunn. Yes.
Mr. Bilirakis. What do you mean by that?
Mr. Nunn. If we have a device that we cannot get certified
or determine that it is compliant, we will be prepared to
either retire it from service or have a workaround. We know
that some of our EKG machines will not be technically
compliant, and we will have a workaround in place, so that that
does not impact the patient or our storage of information,
which is really the----
Mr. Bilirakis. So, you are basically saying that you feel
that your hospitals will be completely up to par by the year
2000, by January 1, 2000. So all of the medical devices may not
be, but your hospitals will be----
Mr. Nunn. Yes.
Mr. Bilirakis. [continuing] will be alert, et cetera?
Mr. Nunn. Yes.
Mr. Bilirakis. That is what you are saying. Now, you know,
I think I have kind of expressed it here; sure, we are
concerned about the FDA role and things of that nature, but we
also express, I think, maybe even more concern with devices at
the hospital level, and rural healthcare, and, of course, in
the homes, and that sort of thing.
What is the percentage of hospitals that belong to the
American Hospital Association? I mean, they don't all belong to
the AHA?
Mr. Nunn. No. There are 5,000 hospitals in the American
Hospital Association.
Mr. Bilirakis. But there is a lot more than 5,000 hospitals
out there.
Mr. Nunn. Yes.
Mr. Bilirakis. So you are working with your hospitals?
Mr. Nunn. That is correct.
Mr. Bilirakis. How about all the others that are not
members of the AHA? In terms of being ready?
Mr. Nunn. I can't comment on their----
Mr. Bilirakis. This is not a pitch now for the American
Hospital Association, although I would suggest probably a good
idea that they all be members.
Well, all right, my time is up, but you know we are really
concerned about this and I am not sure--I mean, frankly, I am a
little more optimistic in listening to you all. I am not saying
that FDA has lowered that optimism somewhat, but I guess I see
a gap there, particularly when it involves the hospitals, home
health, and whatnot, which FDA apparently does not have overall
jurisdiction responsibility for, and we not just really sure
who is going to cover that gap. That is really what concerns
me, I guess, more than anything else.
Well, we may have further questions. I was really going to
ask these good people for some hard data on some of the things
they have been telling us, but at this point, again, I don't
want to add just make-work to their heavy responsibilities in
this regard. If we request that, we will do so at another time
and give you an opportunity to respond.
Thank you very much. Thank you, Mr. Chairman.
Mr. Upton. Thank you, Mr. Chairman.
And I, again, appreciate the testimony from the witnesses,
all the witnesses on both panels this morning. And we do have
four votes in a row on the House floor, so we are going to be
scurrying over there, but this hearing is now adjourned. Thank
you.
[Whereupon, at 12:49 p.m., the subcommittees were
adjourned.]