<DOC>
[109th Congress House Hearings]
[From the U.S. Government Printing Office via GPO Access]
[DOCID: f:30528.wais]
MEDICAL DEVICE SAFETY: HOW FDA REGULATES THE REPROCESSING OF SUPPOSEDLY
SINGLE-USE DEVICES
=======================================================================
HEARING
before the
COMMITTEE ON
GOVERNMENT REFORM
HOUSE OF REPRESENTATIVES
ONE HUNDRED NINTH CONGRESS
SECOND SESSION
__________
SEPTEMBER 26, 2006
__________
Serial No. 109-190
__________
Printed for the use of the Committee on Government Reform
Available via the World Wide Web: http://www.gpoaccess.gov/congress/
index.html
http://www.house.gov/reform
______
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COMMITTEE ON GOVERNMENT REFORM
TOM DAVIS, Virginia, Chairman
CHRISTOPHER SHAYS, Connecticut HENRY A. WAXMAN, California
DAN BURTON, Indiana TOM LANTOS, California
ILEANA ROS-LEHTINEN, Florida MAJOR R. OWENS, New York
JOHN M. McHUGH, New York EDOLPHUS TOWNS, New York
JOHN L. MICA, Florida PAUL E. KANJORSKI, Pennsylvania
GIL GUTKNECHT, Minnesota CAROLYN B. MALONEY, New York
MARK E. SOUDER, Indiana ELIJAH E. CUMMINGS, Maryland
STEVEN C. LaTOURETTE, Ohio DENNIS J. KUCINICH, Ohio
TODD RUSSELL PLATTS, Pennsylvania DANNY K. DAVIS, Illinois
CHRIS CANNON, Utah WM. LACY CLAY, Missouri
JOHN J. DUNCAN, Jr., Tennessee DIANE E. WATSON, California
CANDICE S. MILLER, Michigan STEPHEN F. LYNCH, Massachusetts
MICHAEL R. TURNER, Ohio CHRIS VAN HOLLEN, Maryland
DARRELL E. ISSA, California LINDA T. SANCHEZ, California
JON C. PORTER, Nevada C.A. DUTCH RUPPERSBERGER, Maryland
KENNY MARCHANT, Texas BRIAN HIGGINS, New York
LYNN A. WESTMORELAND, Georgia ELEANOR HOLMES NORTON, District of
PATRICK T. McHENRY, North Carolina Columbia
CHARLES W. DENT, Pennsylvania ------
VIRGINIA FOXX, North Carolina BERNARD SANDERS, Vermont
JEAN SCHMIDT, Ohio (Independent)
BRIAN P. BILBRAY, California
David Marin, Staff Director
Lawrence Halloran, Deputy Staff Director
Benjamin Chance, Clerk
Michael Galindo, Clerk
Phil Barnett, Minority Chief of Staff/Chief Counsel
C O N T E N T S
----------
Page
Hearing held on september 26, 2006............................... 1
Statement of:
Selvey, Don, senior vice president, regulatory affairs and
quality assurance, Ascent Healthcare Solutions, Inc.;
Dennis J. Toussaint, director, regulatory affairs,
Sterilmed, Inc.; and Stephen J. Ubl, president and CEO,
Advanced Medical Technology Association.................... 39
Selvey, Don.............................................. 39
Toussaint, Dennis J...................................... 56
Ubl, Stephen J........................................... 73
Schultz, Dr. Daniel G., Director, Center for Devices and
Radiological Health, Food and Drug Administration.......... 13
Letters, statements, etc., submitted for the record by:
Davis, Chairman Tom, a Representative in Congress from the
State of Virginia, prepared statement of................... 4
Schultz, Dr. Daniel G., Director, Center for Devices and
Radiological Health, Food and Drug Administration, prepared
statement of............................................... 17
Selvey, Don, senior vice president, regulatory affairs and
quality assurance, Ascent Healthcare Solutions, Inc.,
prepared statement of...................................... 41
Toussaint, Dennis J., director, regulatory affairs,
Sterilmed, Inc., prepared statement of..................... 58
Towns, Hon. Edolphus, a Representative in Congress from the
State of New York, prepared statement of................... 92
Ubl, Stephen J., president and CEO, Advanced Medical
Technology Association, prepared statement of.............. 75
Waxman, Hon. Henry A., a Representative in Congress from the
State of California, prepared statement of................. 8
MEDICAL DEVICE SAFETY: HOW FDA REGULATES THE REPROCESSING OF SUPPOSEDLY
SINGLE-USE DEVICES
----------
TUESDAY, SEPTEMBER 26, 2006,
House of Representatives,
Committee on Government Reform,
Washington, DC.
The committee met, pursuant to notice, at 10:40 a.m., in
room 2157, Rayburn House Office Building, Hon. Tom Davis
(chairman of the committee) presiding.
Present: Representatives Tom Davis, Mica, Gutknecht,
Porter, Foxx, Schmidt, Waxman, Owens, Towns, Cummings,
Kucinich, and Norton.
Staff present: David Marin, staff director; Larry Halloran,
deputy staff director; Keith Ausbrook, chief counsel; A. Brooke
Bennett, counsel; Susie Schulte, professional staff member;
Michael Galindo and Benjamin Chance, clerks; Karen Lightfoot,
minority communications director/senior policy advisor; Stephen
Cha, minority professional staff member; Sarah Despres,
minority counsel; Early Green, minority chief clerk; and Jean
Gosa, minority assistant clerk.
Chairman Tom Davis. I apologize for being a couple of
minutes late. I want to welcome everybody to today's hearing on
the Food and Drug Administration's regulation of reprocessed
single-use devices.
The purpose of this hearing is to assess FDA's oversight of
the reprocessing industry and determine what, if any,
additional measures are needed to assure reprocessed SUDs are
effective and safe. FDA is responsible for approving these
devices. Manufacturers choose to submit applications for
single-use only designation as opposed to multi-use
designation. FDA, however, allows reprocessed SUDs to be
marketed if they are substantially equivalent to the original
device.
Many of you may not be aware that several commonly used
medical devices are cleaned and resterilized to be used by
hospitals more than once. Devices such as catheters, biopsy
forceps, and surgical tools are often designated for one-time
use, but hospitals routinely pay to have them reprocessed to
cut costs and reduce medical waste. For example, new biopsy
forceps can cost $60, yet reused forceps can cost as little as
$15. Savings from use of reprocessed devices can be
significant.
Original device manufacturers have said, however, they
cannot guarantee the safety of SUDs once they are reprocessed
and reused. Reprocessors contend there is no sufficient or
credible evidence to indicate the use of reprocessed medical
devices is riskier than the use of new ones. Hospitals may save
overhead costs, but what is the cost of patient's health? That
is just one of the many questions we are going to ask today.
The committee's interest began with a series of articles in
the Washington Post that reported many instances of patient
injury associated with the use of defective and unsterile
reprocessed devices. Mr. Waxman and I wrote to the FDA, asking
for information on device safety regulations and the adequacy
of adverse event data. The FDA responded that the data in hand
did not establish a clear causal link between reprocessed
devices and subsequent adverse health effects, but we need to
know whether that is because the reprocessed devices are safe
or because MedWatch, the adverse event monitoring system, is
too passive or insensitive to capture subtle but potentially
deadly trends.
Today's hearing will question whether FDA's current
MedWatch reporting system can accurately capture adverse events
resulting from reprocessed devices. We will ask FDA how new
labeling requirements under the Medical Device User Fee and
Modernization Act are working to help improve the MedWatch
system. Effective last month, reprocessed devices are required
to be stamped or tagged with a label indicating they have been
reprocessed. Previously, only the packaging was required to
identify the device was reprocessed, and most doctors were
unaware devices were reprocessed as packaging is often removed
prior to use in the operating room.
Now look, I realize some of our witnesses will say it is
too early to clearly determine what impact the new labeling
requirement will have on adverse event reporting, and that is
OK. Today's hearing will not be the committee's final look at
the issue.
Mr. Waxman and I have asked GAO to update its June 2000
report on SUDs. GAO's initial report found little harm from
reuse but recommended additional oversight by the FDA. Because
FDA regulation of the industry has increased significantly
since 2000, the committee asked GAO to specifically examine the
safety of SUD reprocessing, the adequacy of FDA's oversight,
and how reprocessed SUDs compare to original devices. GAO has
accepted this request, but they have not yet initiated work.
Before we move to our first panel, I am going to express my
disappointment in the original device manufacturing industry.
We have no device makers testifying today because they
preferred to speak through their trade association, AdvaMed.
Specifically, C.R. Bard, a company from Murray Hill, NJ, was
invited to testify, but they declined to appear. We would have
preferred to have direct testimony from companies so they would
be able to provide specific examples and commentary regarding
their specific devices. Despite the committee's disappointment
with the lack of original device manufacturer witnesses, we
will continue our discussions with those companies.
We have the reprocessors represented by SterilMed and
Ascent Healthcare Solutions, the two largest companies in the
business, ready to testify today, and I want to thank them for
appearing.
I look forward to your testimony from both panels on this
important issue.
[The prepared statement of Chairman Tom Davis follows:]
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Chairman Tom Davis. I would now recognize Mr. Waxman.
Mr. Waxman. Thank you, Mr. Chairman for holding today's
hearing on the safety of reprocessed medical devices.
FDA's oversight of medical devices is an important issue
that does not get sufficient attention. Medical devices can be
as critical to a patient's care as the drugs they are
prescribed. There are devices that keep the heart beating, to
measure the level of oxygen in blood, to deliver pain
medication, and to test blood pressure. When devices fail,
there can be very serious consequences including death.
Today's hearing is focused on the risks of reprocessed
medical devices, but the safety risks posed by medical devices
are by no means limited to reprocessed devices. One example is
the recent manufacturing defects in brand new implantable
cardiac defibrillators. These are devices that are implanted
into people with heart problems and that can save a person's
life by shocking a nonfunctioning heart back into rhythm. Even
after one major manufacturer of defibrillators learned that
some of its devices were flawed, the company did not inform
physicians or the public, and the faulty defibrillators
continued to be surgically implanted.
Eventually, there was an after the fact recall, but by this
time, the faulty defibrillators had already been implanted and
patients were put into the position of having to live with
defibrillators that could fail or undergoing another surgery to
have them replaced. That is a terrible position for anyone to
be in.
In recent years, there has been a concerted effort to
strengthen FDA regulation of reprocessed devices. A series of
congressional hearings and a GAO investigation showed that this
was an area that needed more regulation. FDA then asserted its
jurisdiction over device reprocessors, subjecting them to the
same standards as other device manufacturers, and in 2002 and
in 2005, Congress imposed additional requirements on the
manufacturers. The last of the new rules for reprocessed
devices went into effect in August. As a result, we no longer
have a regulatory scheme that allows devices to be cleaned and
reused with no oversight. Under the law, reprocessed devices
are actually more tightly regulated now than their single-use
counterparts.
I understand that the original equipment manufacturers do
not like reprocessing. They have an economic concern about this
practice. The practice of reprocessing cuts into their profits
and often forces them to lower their prices to stay
competitive. Their agenda, however, should not be our agenda.
The safety concerns with reprocessed devices have to be
understood within the broader context of device safety. Under
the FDA's current regulatory scheme for reprocessed devices,
FDA assures us that a reprocessed device will meet the same
exact standards as the original device. It must be just as
strong and just as sterile as it was the first time it was
used. So, as we question FDA's ability to assure that
reprocessed devices are safe and effective, as we should, we
must recognize that we are, in effect, questioning FDA's
ability to ensure that all devices are safe and effective.
We will hear today that FDA is not devoting enough
resources to enforcing the requirements that apply to
reprocessed devices. I share these concerns.
I want to learn how the new regulations for manufacturers
of reprocessed devices are being implemented, and I hope we
will do everything we can to urge FDA to be more effective
bringing enforcement actions for violations of the regulations
governing reprocessed devices. But we must recognize that FDA's
failure to protect the public extends beyond reprocessed
devices. The reality is that FDA is also not doing a good job
protecting Americans from the dangers of new devices, and it is
the original devices, not reprocessed ones, that cause the
largest number of deaths and injuries.
I issued a report in June that revealed that FDA
enforcement actions have declined significantly under the Bush
administration. Among FDA's regulatory centers, the Center for
Devices and Radiological Health saw the biggest decline in
enforcement with a 65 percent drop in the number of warning
letters it issued from 2000 to 2005. This report made clear
that in the last 5 years, FDA has chosen to ignore the advice
of its own staff, has taken far fewer enforcement actions than
in previous years, and has left the industry to police itself.
In order to put the issue of reprocessed medical devices
into the broader context of device safety, I requested that Dr.
Peter Lurie from Public Citizen be invited to testify. For
reasons that I do not understand, my request was denied. Dr.
Lurie is a consumer advocate with no financial stake in this
issue. He would have provided an important public health
perspective to today's hearing, and it is unfortunate he was
not allowed to participate.
Americans rely on the FDA to make sure that the foods they
eat, the drugs they take, and the devices that they need are
safe and effective. Unfortunately, recent tragedies like the
faulty defibrillators have shaken consumers' confidence that
FDA is effectively fulfilling this role.
I look forward to learning from our witnesses today steps
we can take to strengthen FDA's oversight of all medical
devices so that we can have this faith restored. I thank the
witnesses for coming.
Thank you, Mr. Chairman.
[The prepared statement of Hon. Henry A. Waxman follows:]
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Chairman Tom Davis. Thank you.
Any other Members wish to make opening statements?
Mrs. Schmidt.
Mrs. Schmidt. Thank you, Mr. Chairman. I will be brief. I
really appreciate the opportunity to have this hearing today. I
first became aware of the issue of using reprocessed single-use
medical devices in my own district with people that had
concerns over the fact that patients may not know these devices
are being used, doctors may not know that these devices are
being used, and the quality of them being reprocessed.
I look forward to an insightful debate on this issue. The
concern and the bottom line that I have is that when a patient
seeks medical treatment that the best care is being provided,
the safest care is being provided, and that the patient
understands that when a reused device is going to be used, that
they know the ramifications of that.
I thank you very much for the opportunity to learn more
about this.
Chairman Tom Davis. Thank you very much.
Any other Members wish to make opening statements?
If not, we will proceed to our first panel. We have Dr.
Daniel Schultz, the Director of the Center for Devices and
Radiological at the Food and Drug Administration.
Dr. Schultz, thank you for being here. Why don't you just
remain standing, and I will swear you in.
[Witness sworn.]
Chairman Tom Davis. Thank you.
You have a light in front of you that turns orange after 4
minutes, red after 5. Your entire statement is part of the
record, and questions will be based on your entire written
statement. Thanks for being with us.
STATEMENT OF DR. DANIEL G. SCHULTZ, DIRECTOR, CENTER FOR
DEVICES AND RADIOLOGICAL HEALTH, FOOD AND DRUG ADMINISTRATION
Dr. Schultz. Good morning, Mr. Chairman, members of the
committee.
My name is Dan Schultz. I am Director of the Center for
Devices and Radiological Health at the Food and Drug
Administration. The safety of medical devices is of utmost
importance to the agency, and I appreciate the opportunity to
discuss the safety and effectiveness and manufacturing quality
of reprocessed single-use devices or SUDs.
My written testimony includes an overview of our regulatory
authority for medical devices. FDA classifies medical devices
into Class I, II, and III, based on risk, Class III being the
highest risk. Currently, only Class I and II single-use device
types have been cleared by FDA for reprocessing.
Let me provide some background on the regulation of
reprocessed devices. In August 2000, FDA issued guidance
enforcement priorities for single-use devices reprocessed by
third parties in hospitals. Again, this was prior to any
specific legislation on this issue. It was based on a series of
meetings that we held and input from stakeholders, which
suggested that there was interest in having closer regulation
on this topic.
This guidance set forth FDA's priorities for enforcing pre-
market submission and post-market requirements for
manufacturers who wish to market reprocessed SUDs. The guidance
document stated that any third party and hospital reprocessor
should comply with requirements pertaining to registration and
listing, medical device reporting, medical device tracking,
medical device corrections and removals, the quality system
regulation, labeling, and pre-market submission. Essentially,
at that time, reprocessors were placed on the same regulatory
framework as the OEMs.
Prior to issuance of this guidance, reprocessors were not
consistently held accountable to any of these requirements. In
2002, with enactment of MDUFMA, Congress mandated a number of
new requirements for SUD reprocessors including, for certain
SUDs, the pre-market submission of data that exceeded the
requirements for OEMs. Certain reprocessed SUD types that
present the greatest potential risk of infection and inadequate
performance following reprocessing and that were previously
exempt from pre-market submission were no longer exempt.
MDUFMA also created a new type of pre-market submission
called a pre-market report for Class III reprocessed SUDs that
otherwise would have required a pre-market approval
application. MDUFMA also required a change to FDA's MedWatch
voluntary and mandatory reporting forms to identify adverse
events involving reprocessed SUDs. As of August 1, 2006, MDUFMA
also requires reprocessed SUDs to bear the name, abbreviation,
symbol of the reprocessor, either on the device itself, on an
attachment, or a detachable label.
Under the FD&C Act, before introducing a device to market,
manufacturers must submit a notification of 510(k) and obtain
FDA clearance unless the device has been exempted. MDUFMA
required FDA to identify previously exempt device types that,
if processed as an SUD, would now require 510(k) submission
including the submission of validation data. In addition,
MDUFMA required the FDA identify SUDs already subject to 510(k)
pre-market requirements but that would now also require the
submission of validation data. Validation data include cleaning
and sterilization and functional performance data demonstrating
that each SUD will remain substantially equivalent to its
predicate after the maximum number of times the device is
intended to be reprocessed.
On June 1, 2004, FDA issued Guidance for Industry and FDA
Staff, MDUFMA 2002, Validation Data in Pre-market Notification
for Reprocessed Single-Use Medical Devices. This document
describes the types of validation data that FDA expects to be
submitted on cleaning, sterilization, and functional
performance, the timeframe for FDA's review of these
submissions, and what actions the agency intends to take if it
finds a reprocessed SUD to be not substantially equivalent.
As of September 2006, FDA has received 200 pre-market
notification submissions for reprocessed SUDs, each covering
from a single to as many as several hundred device models.
Approximately 67 percent have been cleared by the agency. The
remaining were not cleared for reasons such as inadequate
validation data, lack of necessary information from the
reprocessor, withdrawal of the application, or lack of response
to FDA's request for data. Just to give you some perspective on
this and put it in context, of the total number of 510(k)'s
that we received, approximately 88 percent of all those are
cleared.
Inspections serve as a bridge between pre and post-market
activities. On the average, FDA has conducted inspections of
reprocessor firms once every 2 years, a rate considerably
higher than the one in every 4 years for OEMs. All known
reprocessing firms have been inspected within the last 2 years.
FDA continues to evaluate newly registered firms to confirm
whether they are performing SUD reprocessing and updates its
inspectional plan as required.
Post-market; post-market monitoring of device-related
adverse events and product problems is accomplished through the
MDR system. MDR reports include deaths, serious injury, and
device malfunctions. Healthcare facilities are required to
report deaths suspected to be device-related to both FDA and
the manufacturer/reprocessor and serious injuries to the
manufacturer/reprocessor. FDA also receives voluntary reports
generally from healthcare professionals through its MedWatch
reporting system. CDRH receives approximately 200,000 device-
related adverse event reports per year.
Can I continue? Oh, sorry.
As you know, on January 24, 2006, I and others briefed the
committee staff about SUD reprocessing. We searched our
Manufacturer and User Facility Device Experience data base for
reports from October 22, 2003, which is when the MDUFMA
legislation went into effect, to December 13, 2005, that were
coded as adverse events associated with reprocessed SUDs.
Analysis of these reports did not disclose a clear link between
a reprocessed SUD and subsequent patient injury or death.
In July 2006, the agency updated the search to include all
reports between October 2003, and July 2006. FDA has received a
total of 434 reports and, of these, approximately 65 reports
involved or were suspected to involve reprocessed SUDs. These
AEs may be associated with reprocessing. They may also be
associated with the medical condition of the patient, the
medical procedure, or other confounding factors. We are seeing
that the same types of adverse events reported to be associated
with the use of SUDs are similar for new, non-reprocessed
devices.
To learn more about how reprocessing was actually occurring
from a user standpoint, we conducted a survey under our Medical
Product Device Safety Network or MedSun. FDA's MedSun is
comprised of over 350 hospitals that identify and report device
problems, and this is a more active surveillance system as
opposed to the MAUDE system which is a much more passive
system. Representatives from more than 50 of these facilities
provided feedback on their experience with reprocessed SUDs to
FDA staff. In general, participants had a favorable view of
reprocessed SUDs. There were no reports with specific problems
with SUD-related infections, and participants did not report a
greater concern with mechanical problems associated with
reprocessed SUDs compared to non-reprocessed SUDs.
I would like to emphasize, however, that one of the
statements, and there was some variability in terms of the
comments that we got, but one of the statements that was clear
and was totally consistent was the idea that it was, that they
found it necessary and desirable for FDA to have a strong
oversight over this process.
The agency continues to review and assess the practice of
reprocessing SUDs. I have some specifics in my written summary.
Just yesterday, FDA published rules amending certain
classification regulations for reprocessed SUDs formerly exempt
from pre-market, those previously subjected to pre-market
notification, and for which validation data are now necessary
in a 510(k). These amendments will help reprocessors and other
stakeholders to know which devices are being reprocessed and
allow them to submit the data that they need to demonstrate
that their device is substantially equivalent.
We have also recently updated our Web site. We have also
recently initiated a dedicated post-market team to look
specifically at the adverse events associated with
reprocessing, and we continue to update our inspection plan to
make sure that we are inspecting all of the reprocessors on a
regular basis.
Available data show that certain--and I emphasize the word,
certain--SUDs can be reprocessed with a reasonable assurance of
safety and effectiveness. FDA believes that reprocessed SUDs,
that meet FDA's regulatory requirements are as safe and
effective as their predicate. The law and regulations in place
are designed to protect the public health by assuring that
reprocessing is based on sound science. We continue to monitor
the performance of these devices and to assess and refine our
ability to regulate them appropriately.
Mr. Chairman, I apologize for running over. Thank you again
for the opportunity to address this important topic.
[The prepared statement of Dr. Schultz follows:]
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Chairman Tom Davis. Thank you very much.
I am going to start the questioning with Mr. Gutknecht.
Mr. Gutknecht. Mr. Chairman, I don't have a question so
much as a comment.
I am delighted the FDA is taking some of these issues
seriously, but I just want to make sure that we don't overstate
the danger here. I just don't want consumers to believe that
there is real risk.
In your professional judgment, how many American consumers
have been injured by some of these reused technologies?
Dr. Schultz. I wish I could give you an exact count; I
can't.
Again, we have looked at all of the reports that have been
submitted to us, most of the reports, and we were given
specific authority to designate those reports as whether they
are reprocessed or non-reprocessed. Unfortunately, a lot of
those reports were incorrectly designated. When we looked at
them specifically one by one, of those that remained, there
certainly are some that could have been associated with
reprocessing, but based on the data and actually the in-depth
analysis of those individual reports, as I said, it is very
difficult to precisely, precisely define which ones were, in
fact, associated with the reprocessing versus the device or the
overall procedure. I apologize for not being able to give you a
more specific answer, but that is the honest answer of what we
currently know.
Mr. Gutknecht. My point really is, Mr. Chairman and
Members, I think we have to put this in some context. The
unfortunate fact is that somewhere between 6,000 and 10,000
Americans die every year in hospitals as a result of either
getting the wrong medication or an infection which they
actually caught while they were in the hospital. In the very
rare circumstance of that infection, did that have anything to
do with a reprocessed medical device?
I think it is important we have this hearing, Mr. Chairman,
but I think we have to put it in context. No. 1, we don't have
very good data, and second, the data that we do have doesn't
suggest that American consumers, American patients are at any
undue risk because of the reprocessing of medical devices.
I know in talking to some of the healthcare people in my
district and in the State, they do want to use these because
they can see significant savings rather than having to buy all
new equipment. If it were up to the device manufacturers, there
would be no reprocessing at all.
So the only thing I would say--and I want to thank you for
your testimony--is that the evidence here is pretty scant that
there is real harm being done to American consumers by this
technology.
I yield back.
Chairman Tom Davis. Thank you very much.
Mr. Waxman.
Mr. Waxman. Thank you, Dr. Schultz, for your presentation.
As I mentioned in my opening comments, I didn't really want
to restrict my comments to reprocessed devices alone because in
some ways there is a blur between the two. I do want to ask you
about what your office is doing regarding device safety
generally.
I mentioned in my opening comments the cardiac
defibrillators made by Guidant. The New York Times broke the
story about the Guidant pacemakers. There was little movement
by your agency to look further into the company, despite
reports of short circuits for years preceding this effort. Your
agency, in fact, knew about these problems for years before the
New York Times story. Can you explain your agency's delay in
action?
Dr. Schultz. Yes, we have looked at that very carefully,
Mr. Waxman, because obviously it was an issue that concerned us
a lot as well.
One of the things that we have done over the course of the
last year is to look at all the different ways that we get
input regarding medical devices, and I think what we found is
that we get input from a lot of different sources. We get input
from patient reports. We get input from inspections. We get
input from reports that manufacturers are required to submit as
part of their routine post-market reporting, especially on PMA
devices. I think one of the things that we have found is that
it is very difficult sometimes to, what I call, connect the
dots and to be able to put together the information, the
patient report information, the inspectional information, and
the updated manufacturing information.
Mr. Waxman. Notwithstanding that, obviously you have to
connect the dots before you do something, but I guess one of
the sources of information is reading the newspaper because
they seemed to come up with a story that connected the story in
advance of the FDA.
I wonder if this is part of the problem. FDA's enforcement
actions have declined under the Bush administration. In fact,
your Center on Devices had the greatest drop with 65 percent
fewer warning letters in 2005 than in 2000. How can you explain
such a sharp dropoff in enforcement during a time of increasing
problems in devices such as implantable pacemakers and
defibrillators?
Dr. Schultz. Well, I am not sure that, I am not sure I
would characterize it as increasing problems, and in terms of
the 65 percent number, I don't have that number in front of me,
but I certainly would take you, that that is, in fact, the
number. I think that one of the things that we have been asked
to do is to make sure that the warning letters that we do send
out are consistent and are reviewed at higher levels to make
sure that they are, in fact, consistent so that we are not
sending warning letters to some companies as opposed to other
companies.
Other than that, I can tell you that the people that I work
with and the people that are in my center are constantly
looking at problems related to manufacturing and submitting
appropriate, what I consider to be appropriate action items to
deal with those problems. Sometimes they are warning letters.
Sometimes they may be so-called untitled letters where we feel
that some of those corrections can be made in other ways.
Sometimes they are injunctions. Sometimes they are seizures.
Mr. Waxman. Have you ever had your staff recommend
enforcement action and then send it up to other higher levels
than the FDA and have it turned it down?
Dr. Schultz. I am sure that there are instances where
warning letters have gone through different layers of review
and have not gone forward. I can't tell you specifically.
Mr. Waxman. Maybe you can get us some information for the
record.
Dr. Schultz. We can do that. We can do that.
Mr. Waxman. MDUFMA required FDA to develop a list of
reprocessed devices for which companies would be required to
submit supplemental validation data. Can you walk us through
the process FDA used to select the devices on that list?
Dr. Schultz. Sure; basically, we used sort of a dual
approach. One was using the so-called Spaulding criteria where
we looked at the inherent risk of that particular type of
device in terms of what part of the body it came in contact
with. Under those criteria, there are certain types of devices
that touch normally sterile parts of the body, for instance,
the inside of the abdominal cavity or the chest cavity; there
are other what is called semi-critical devices which touch
mucosal surfaces such as the inside of the gastrointestinal
tract or the inside of the respiratory tract; and then there
are low risk devices which basically come in contact with
intact skin.
So we looked at that. We sort of used that as a starting
point, and then we also looked at the device itself. There are
some devices that are relatively simple and straightforward in
terms of how they could be cleaned and how they could be
sterilized, and we tried to gauge the complexity of the device
and how difficult it would be to reprocess in conjunction with
the criticality of how the device was being used.
So we combined those two sets of criteria and came up with
a list of what we thought were the most important, the most
urgent to regulate, and then sort of worked our way down from
there.
Mr. Waxman. Thank you.
Thank you, Mr. Chairman.
Chairman Tom Davis. Thank you.
Mrs. Schmidt.
Mrs. Schmidt. Thank you, Mr. Chairman. I have a few
questions.
I think the first and the most basic that I have is I have
a little trouble with if something is designed for single use,
how can it be reprocessed too for dual use?
Let me give you an analogy. In auto racing, there is a
difference between drag cars and cars that go around and around
on a track. Drag cars' engines are built for a single use, a
single time, and then they get rebuilt. They are not built to
go more than once. If these devices are being built to go one
time, how can they be reprocessed and be safe?
Dr. Schultz. OK; I am not an expert on car racing, but what
I would tell you is when we look at any product, whether it be
a reprocessed product or a non-reprocessed product, we don't
make a decision sort of before the fact as to whether or not
that particular product can or can't be used in that particular
manner. What we do is we say, OK, you want to do this. You want
to label your product to be used in such a way. You must
provide us with the data that shows that, in fact, that can
happen safely and effectively.
You are right; I think in some cases, there are single-use
devices that cannot and should not be reprocessed. But what we
have found in terms of our own review process, not what
somebody tells us or doesn't tell us but in terms of our own
review process is that, in fact, some devices--again, I tried
to be careful in my testimony that certain devices, we believe,
can be reprocessed safely and effectively--that some devices,
in fact, can be used more than once if they are properly
reprocessed. And we clear those devices if, and only if, the
manufacturer, in this case, reprocessor, provides us with data
to demonstrate that is, in fact, the case and they have to tell
us, in fact, how often the device can be reprocessed safely.
Mrs. Schmidt. Mr. Chairman, may I have two more questions?
Chairman Tom Davis. Yes, go ahead.
Mrs. Schmidt. Thank you.
The second one I have is on the labeling of the devices.
Dr. Schultz. Right.
Mrs. Schmidt. Last winter, I had the opportunity to
actually review some of these devices, and it would be very,
very hard for anyone including a physician to figure out
whether the device was new or reprocessed because, in some
cases, there is just a little teeny dot on the instrument to
note that it is a reprocessed instrument.
Dr. Schultz. Right.
Mrs. Schmidt. What kind of labeling do you have in place?
Dr. Schultz. The new statute with regards to device
labeling, as was mentioned in some of the opening comments,
went into effect on August 6th. I think there was a recognition
by Congress that there needed to be a clearer designation of
those devices that are reprocessed versus those devices that
are, in fact, being used for the first time, and that was
something that needed to be done. That was part of the MDUFSA
legislation, and that legislation went into effect as of August
of this year. So, in terms of what was done, I can tell you
that we did, in fact, that those requirements did go into
effect. In terms of the outcome, what effect, and how
successful that will be in terms of alleviating some of the
concerns that you have heard, I think we will have to just wait
and see what happens.
Mrs. Schmidt. A followup, sir; what kind of label? What
does this label look like that is one of these devices now?
Dr. Schultz. It really depends on the device itself. This
is a problem with labeling in general. Some devices can have
relatively large, prominent labels if they are large devices.
Some devices, the labeling is, by definition, based on the size
of the device, fairly small. In those cases, there are
exceptions where the label can actually be an attachment to the
device as opposed to actually being imbedded in the device
itself.
So, again, I think what we are trying to do is take sort of
a common sense approach to this to make sure that the labeling
actually is legible and is of a size that people can actually
see it and understand who the device manufacturer is for that
particular device.
Mrs. Schmidt. One final question, if I may; you said in
your testimony that there is a savings aspect to this. Can you
give me an indication of what the cost savings to reuse the
device per procedure?
Dr. Schultz. I think what I said was that in our talking to
the user hospitals, that they expressed a benefit in terms of
cost savings. We, at FDA, do not look at cost as one of our
criteria regarding whether we clear or don't clear devices for
market. We simply look at whether the device meets the criteria
for safety and effectiveness.
Mrs. Schmidt. Thank you, sir.
Chairman Tom Davis. Mr. Towns.
Mr. Towns. Thank you very much, Mr. Chairman, and thank you
for holding this hearing.
Dr. Schultz, do you think that the patient has the right to
know that this is being reused or that they have the right to
refuse the treatment with the reprocessed if they know it? What
is your position on that?
Dr. Schultz. Well, in terms of our authority, we clear
devices based on the data that is provided to us, and once a
device is clear for marketing, it is designated as a legally
marketed product. So we don't discriminate between devices that
are reprocessed versus those that are not reprocessed, just as
if we don't discriminate between various models and various
different product types.
So I guess I am not trying to avoid your question. I think
it is a good question.
Mr. Towns. You are not answering it; you know that.
Dr. Schultz. Well, I guess what I am saying is that my best
understanding, is that our authority does not extend to
deciding whether or not patients should be informed about
reprocessing or lack of reprocessing. Our authority is to make
sure that the devices, in fact, are as safe and effective as
the original devices.
Mr. Towns. The testimony here is very conflicting, of
course. Do you feel that maybe an independent group should
analyze and evaluate this because when you listen or read the
testimony here, one person is saying it is great, it is no
problem, and another is saying it is not. Do you think that
maybe we should have some independent person to evaluate all of
this?
Dr. Schultz. Congressman, if I may, I would like to believe
that we do, in fact, function as that independent person
because frankly whether or not a device is reprocessed or
whether it is an original device, I and my staff have one
concern and one concern only, which is will that device perform
as intended and will it provide a benefit to the patient in
whom it is being used. So I can't speak to whether there ought
to be another independent body looking at these questions, but
I can tell you that is how we look at that.
Mr. Towns. The question is: Do all hospitals report to you
and indicate to you that there is a problem, if there is one,
all hospitals?
Dr. Schultz. All hospitals are required to report problems,
and that, as I mentioned, that is under the passive reporting
system that we have, the so-called MDR system. In addition to
that, I mentioned that we actually, on our own initiative,
instituted a survey of some of our MedSun facilities to try to
get a better handle on just the kind of question that you are
asking. Are there concerns? What are the concerns? Do people
think that this is a good process, a bad process?
Again, the responses were mixed. The responses, basically,
people said no matter what the evidence shows or doesn't show,
they do not believe that they should be using reprocessed
devices. Even within hospitals, what we found was that there
were some doctors, some parts of the hospitals, some, whether
it is G.I. or cardiac may decide we will or won't allow the use
of reprocessed devices. So there was a fair amount of
variability.
What, again, was a clear message to us was we had a
responsibility to clearly identify those devices that have gone
through our review process and let the hospitals know which
ones have gone through the review process, which ones haven't,
and inform them so that they can make up their own minds.
Mr. Towns. Let me ask were you able to identify which types
of hospitals traditionally use the reprocessed? Is it rural
hospitals, inner city hospitals? Were you able to establish a
pattern as to who would use this the most?
Dr. Schultz. To the best of my knowledge, we haven't done
that kind of analysis. My impression was, in participating in
some of those focus group discussions, that they were hospitals
of various sizes and various locations and, in fact, the MedSun
program is designed specifically to include different size and
different locality types of facilities. But I don't have a
specific answer to your question.
Mr. Towns. Let me just raise, Mr. Chairman, one more
question.
Chairman Tom Davis. Sure.
Mr. Towns. I think it was raised earlier on the other end.
Do you think it is appropriate for the FDA to approve a
device as a single-use device and then turn around and approve
the same device after reprocessing? Should new standards or
regulations be put into place to set a standard for what is
labeled as approved for a single use?
In other words, I just sort of have a little problem with
that. If you approve it as a single-use and then you come back,
don't you feel uncomfortable with that process?
Dr. Schultz. I feel that we need to look at these devices
individually. As I said before, some of these devices, in fact,
are labeled for single-use and cannot and should not be
reprocessed. Others that have gone through our full evaluation
process, and if you are interested, I can provide you some
examples of what that evaluation is actually like because that
may be sort of helpful in terms of understanding the kind of
rigor that goes into those evaluations. I have confidence based
on what I know our reviewers are doing and what kind of
requirements they are setting up, that those devices that go
through our full review process and full inspectional process
are, in fact, going to perform as intended.
Mr. Towns. With permission of the chairman, I would
appreciate it if he would submit that.
Chairman Tom Davis. OK; if you could try to get that to us,
that would be helpful.
Dr. Schultz. The specific example; sure.
Mr. Towns. OK; thank you very much.
Chairman Tom Davis. Mr. Cummings.
Mr. Cummings. Thank you very much, Mr. Chairman.
Dr. Schultz, thank you for your testimony. It has been very
enlightening.
I just want to go back. Who usually makes the application,
a reprocessing company?
Dr. Schultz. Yes, yes.
Mr. Cummings. Basically, other than a hospital perhaps
reporting something to you, that is how these things come to
issue, is that right? In other words, is there any other way?
The reprocessing company says we think this is something
that can be reprocessed. You hear about a problem from a
medical establishment.
Dr. Schultz. Correct.
Mr. Cummings. Is there any other way that it would come to
your attention?
Dr. Schultz. We hear about problems from the reprocessors
who get reported back to them, from other parties who get
reports submitted to them, and from individual hospitals and
practitioners.
Mr. Cummings. Let us rewind.
Dr. Schultz. Yes.
Mr. Cummings. So, in other words, you may approve a device
for reprocessing.
Dr. Schultz. Correct.
Mr. Cummings. The reprocessor then discovers that someone
is having a problem with the device.
Dr. Schultz. Correct.
Mr. Cummings. The reprocessor then has a duty to notify
you.
Dr. Schultz. That is correct.
Mr. Cummings. When the reprocessor notifies you, what
happens then?
Dr. Schultz. We look at those reports, decide if there is a
pattern, like we do with other adverse event reports, and then
take appropriate action if, in fact, we see a pattern where a
particular type of device is causing a particular type of
problem.
Mr. Cummings. Have we seen that happen?
Dr. Schultz. We haven't.
Mr. Cummings. We have not yet.
Dr. Schultz. That is, part of the dilemma is that, again,
we see a lot of reports. I mentioned we have seen over 400
reports of reprocessed devices. We see about 200,000 reports of
all devices. And thus far, thus far--and we continue to look--
thus far, we have not seen a specific pattern that would
require us to take a certain action.
Mr. Cummings. Now, let me ask you this. You said something
that I found very, very enlightening and interesting. You said
one of the things that you are most concerned about is making
sure that the reprocessed device--I am not trying to put words
in your mouth, so correct me--is just as good as or just as
safe as the original, is that correct?
Dr. Schultz. That is correct.
Mr. Cummings. Now, it is my understanding that you had
6,500 deaths associated with not reprocessed but original
devices, is that correct, over the last few years?
Dr. Schultz. That is the number that I heard quoted. I
would have to go back and confirm that, but that is the number
that I heard quoted.
Mr. Cummings. Well, would you say there are thousands?
Dr. Schultz. Again, you know, one of the things when we
talk about deaths associated with devices, I think we have to
be extremely careful, just as when we talk about deaths and
adverse events associated with reprocessed devices. I think the
same holds true, in general, about looking at those reports
critically to see whether or not the incident in which a device
was used was actually, the problem was actually caused by the
device or not caused by the device. Again, I don't mean to sort
of over-complicate this, but I----
Mr. Cummings. Doctor, you are not over-complicating. I
understand it. I used to practice medical malpractice, so I
understand.
Dr. Schultz. OK.
Mr. Cummings. There are all kinds of reasons.
Dr. Schultz. Correct.
Mr. Cummings. When you are talking about the human body,
this very strong but very delicate machine, almost anything can
happen. So it is hard sometimes--I understand what you are
saying--to actually pinpoint something to the machine, I mean
to the device.
Dr. Schultz. That is correct.
Mr. Cummings. All right.
Let us go back very quickly and just talk about the
criteria. Once you get that application, what is the criteria?
Is it strength?
I know you talked about the different parts of the body
that it might touch. Tell me about how that--I see my time is
running out--or which part of the body it touches. I want you
to talk about strength of the instrument or whatever. I want
you to talk about exactly what goes into the process.
And one last thing, is there a situation where something
may be approved to, say, use it three times? Then the
reprocessor says, look, I can do something to this, and you
will be able to use it 10 times.
Can you just incorporate that all in your answer, please?
Dr. Schultz. Let me try to work backward so that I try to
cover all those. In terms of the number of times, again, the
reprocessor has the option of defining how many times they
believe the device can be safely reprocessed. When we do our
review, we look at that number that they are proposing, and we
ask a very simple question. Do you have the data to support the
claim that you are making in terms of how many times that
device can be used?
That means that during the review process, we require that
testing be done to show that the device can be used, cleaned,
sterilized if necessary, and that appropriate functional
testing--strength testing, bend testing, whatever type of
mechanical testing our engineers tell us is appropriate for
that particular use--that testing, in fact, either confirmed or
didn't confirm that number of uses is appropriate. Then we will
go back to the manufacturer and say, you have shown us or you
haven't shown us that, in fact, that device can be used that
many times.
Your other question, I think was describe sort of how the
review process is done. That would take a little bit longer,
but let me say that, in general, we use the same set of
criteria that we use for any other device, which is that we
focus on those aspects of the device that relate to the way in
which the device is being used. So if we are talking about a
biopsy forceps, we will be looking very, very carefully at how
the jaws open and close. Is it still able to capture the amount
of tissue that is necessary to make a diagnosis? Is it able to
bend around whatever curves it needs to bend around to get to
the location that it needs to get to in order to perform
optimally? Those would be the kinds of questions in addition
to: Can it be cleaned, can it be disinfected in order to be
able to be used safely?
I don't know if that answers your question.
Mr. Cummings. Thank you very much.
Chairman Tom Davis. Thank you.
Has FDA ever been able to establish a clear causal link
between reprocessed devices and subsequent adverse health
effects?
Dr. Schultz. In general terms?
Chairman Tom Davis. In general.
Dr. Schultz. No.
Chairman Tom Davis. MedWatch is the adverse event
monitoring system, do you think it works well or do you think
it is too passive or insensitive to capture the subtle trends?
Dr. Schultz. I think it is. I think the short answer to
your question, Mr. Chairman, is that we are looking very hard
at the MedWatch system right now for reprocessing in particular
as well as in general to see what MedWatch does well and what
it doesn't do well. And I will tell you that MedWatch has been
extremely useful in terms of allowing us to pick up signals. It
has not been that useful in terms of helping us to analyze
those signals and actually come to answer the kind of question
you are asking, which is why.
You gave us the MedSun program in 1995, I believe, in
FDAMA, that allowed us to have a more active system where we
can actually go out and ask questions and try to get specific
data from various hospitals.
I think that the MedWatch system, it needs to be improved.
We need to do some updating in terms of getting electronic
reports is one thing that I think would be extremely helpful,
which would hopefully make the reports a little more consistent
and also allow us to input those reports more quickly. But I
think that we need to be realistic in terms of what a passive
surveillance system can provide and what needs to be provided
through a more active surveillance system or through ongoing
studies.
Chairman Tom Davis. In its written testimony, AdvaMed
describes two adverse events reports that relate to FDA in
2004. These reports involve malfunction of a reprocessed heart
positioner and a reprocessed endoscopic vein harvester. Did the
FDA act on these reports?
Dr. Schultz. The heart positioner, that question came up as
to whether or not that particular type of device should fall
under the unexempt provision and whether we should be
regulating those. Subsequent to that, we did, in fact, include
that type of device as part of the review process which, again,
required the additional validation data.
I can't give you a specific answer for the other one, but I
certainly will go back and look at it.
Chairman Tom Davis. If you can go back and check.
Dr. Schultz. Yes, sir.
Chairman Tom Davis. FDA, were they able to establish a
causal link between the reprocessing and the adverse health
effect in that?
Dr. Schultz. I don't; again, the information that I got was
from the MDR reports and is what I gave you.
Chairman Tom Davis. Well, let me ask you this. Does FDA
require tracking procedures or are the reprocessing companies
required to develop those procedures as part of its validation
of data requirements?
Dr. Schultz. Could you be more specific when you talk about
tracking?
Chairman Tom Davis. You track the device. You track
individual devices.
Dr. Schultz. These; my best understanding, and I am going
to go back and confirm this, is these do not fall under what we
normally consider to be tracked devices which are usually
things like pacemakers and other sort of immediately
lifesaving, sustaining devices.
Chairman Tom Davis. Well, then what happens when a device
is recalled by an original device manufacturer? Does the FDA
ensure that reprocessed devices are withdrawn from the market,
or is it hard to track?
Dr. Schultz. Yes, I mean these devices are considered
individually.
Chairman Tom Davis. Some are and some aren't is basically
the answer. I guess that is where the debate lies.
Dr. Schultz. I am sorry?
Chairman Tom Davis. I guess that is where the debate is,
reuse, where it can be dangerous and where it can't, and what
should be tracked and what shouldn't and how we get into this.
Thank you very much.
I think we will take a 2-minute recess while we move our
next panel up.
Doctor, thank you. You owe us a couple answers, but I
appreciate your patience.
Dr. Schultz. Thank you very much.
[Recess.]
Chairman Tom Davis. The hearing will reconvene.
We are going to now move to our second panel. We have Mr.
Don Selvey, the senior vice president of Ascent Healthcare
Solutions; Dennis Toussaint, the director of regulatory
affairs, SterilMed; and Stephen Ubl, the president and CEO of
Advanced Medical Technology Association.
It is our policy that we swear you in.
[Witnesses sworn.]
Chairman Tom Davis. Thank you.
Please be seated. I think you know the rules.
Mr. Selvey, we will start with you, and we will move
straight on down and then try to get to questions. Again, your
entire statement is in the record. With most of your
statements, we think we know where we want to go on this, so
you can keep it within 5. If you really want or if you need
extra time, take it, but I would like to keep them within 5
minutes, if we can, and then we will move on to questions.
Thanks for being with us.
STATEMENTS OF DON SELVEY, SENIOR VICE PRESIDENT, REGULATORY
AFFAIRS AND QUALITY ASSURANCE, ASCENT HEALTHCARE SOLUTIONS,
INC.; DENNIS J. TOUSSAINT, DIRECTOR, REGULATORY AFFAIRS,
STERILMED, INC.; AND STEPHEN J. UBL, PRESIDENT AND CEO,
ADVANCED MEDICAL TECHNOLOGY ASSOCIATION
STATEMENT OF DON SELVEY
Mr. Selvey. Thank you, Mr. Chairman, members of the
committee.
I am Don Selvey, the senior vice president for regulatory
affairs and quality assurance at Ascent Healthcare Solutions,
the Nation's largest reprocessor of single-use medical devices.
Although I have more than 16 years experience in the medical
device industry, I am an epidemiologist by training. Prior to
my service in the medical device industry, I spent over a
decade as a public health professional in Arizona, originally
as a registered sanitarian and then as head of Infectious
Disease/Epidemiology and later as Head of the Environmental
Epidemiology program.
Ascent Healthcare Soultions, headquartered in Phoenix, AZ,
employs 800 persons throughout the country. Our customer base
consists of approximately 1,600 hospital and surgery centers in
the United States, including most of those facilities annually
recognized by the U.S. News and World Report as the top
hospitals in America.
We only reprocess low or moderate risk medical devices such
as compression sleeves, electrophysiology catheters, and
orthopedic tools. We do not reprocess high risk medical devices
such as implantables or devices which come into contact with
the central nervous system or the brain. In fact, we estimate
that we are able to reprocess only 1 to 2 percent of devices
labeled for single use.
The emergence of reprocessing in the United States is
rooted in the meaning of the single-use label itself. Contrary
to what one might think, the single-use label is not an FDA
requirement. In fact, FDA does not require any device to carry
a single-use label. Instead, single-use is a designation the
original equipment manufacturer [OEM], chooses, and that choice
is sometimes made in an effort to sell more devices, not for
patient safety reasons. The truth is that a manufacturer could
label an operating table as being for single use if the OEM
believed it could persuade a hospital to throw the table out
after one use.
To show you some of these single-use devices, I brought
along some external fixation devices and some surgical tools.
This, for example, is a clamp. This is a clamp. We are happy to
pass those around, if you like. Here is a surgical saw blade
made of stainless steel. These are the types of single-use
devices we are talking about.
Chairman Tom Davis. I am going to let somebody bring these
up, and we will pass them around.
Mr. Selvey. About two decades ago, some OEMs began to
change the label on certain medical devices from reusable to
single-use, in some cases, without any significant structural
changes in the device that would preclude safe reuse. With this
change in labeling, it became evident to many hospitals that
the single-use label does not necessarily mean only single use
and that certain devices designated by the original
manufacturer as single-use can, in fact, be safely reprocessed.
Further evidence that the single-use label does not always mean
a device can only be used one time is the fact that some
original manufacturers reprocess their own single-use devices.
In fact, some manufacturers partner with third parties to
reprocess devices that manufacturer has labeled as single-use.
Today, reprocessing of devices originally labeled for
single-use is standard practice in the Nation's top hospitals.
Hospitals simply cannot afford to throw out devices that can be
safely reprocessed. These dollars are better spent on
purchasing new medical technology and preserving nursing staff.
The savings generated by reprocessing can be significant. A
2000 GAO report found that for one device alone, the
electrophysiology catheter, individual hospitals are saving
between $200,000 and $1 million annually as a result of
reprocessing.
As the reprocessing industry has grown, so too has the
strident opposition from the original manufacturers who see
reprocessing as an increasing economic threat. The threat is
two-fold. First, reprocessed devices are, on average, about
half the cost of the original devices. Therefore, many
hospitals choose to use reprocessed devices rather than
purchase new ones. This means lower sales for original device
manufacturers. Second, the very existence of reprocessing has
resulted in a decrease in the price of certain new devices.
Lower prices mean lower prices.
Ascent hopes that this hearing today will make clear that
the third party reprocessing in the United States is safe and
that it is highly regulated. In fact, reprocessors are more
stringently regulated than the original equipment industry.
Specifically, reprocessors are required to submit validation
data in our pre-market submission while the manufacturers have
no such requirement. Second, certain devices that require pre-
market submission for the reprocess device have no requirement
for the original version of that device. And third, unlike
OEMs, we reprocessors are required to place an identifying mark
on the device itself, not simply on the label.
Reprocessors provide a valuable service to this country's
hospitals, a service that helps hospitals survive in an era of
spiraling healthcare costs. Additional regulation at either the
Federal or State level is not only unnecessary but also,
because it would limit the ability of hospitals to use
reprocessed devices, would do a disservice to America's
hospitals and patients.
Thank you, Mr. Chairman.
[The prepared statement of Mr. Selvey follows:]
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Chairman Tom Davis. Thank you very much.
Mr. Toussaint.
STATEMENT OF DENNIS J. TOUSSAINT
Mr. Toussaint. Thank you, Mr. Chairman.
My name is Dennis Toussaint, and I am the director of
regulatory affairs at SterilMed. I have been in the medical
device industry for approximately 18 years. Most recently, my
work has been at SterilMed.
SterilMed was founded in 1997 and is a leading provider of
reprocessing and repair services designed to help hospitals and
other healthcare organizations generate substantial cost
savings through better utilization of medical devices. As a
medical device reprocessor, SterilMed cleans, tests, packages,
and sterilizes previously used devices that were originally
labeled for single use only. During a time of rapidly rising
healthcare costs, SterilMed helps its hospital partners free up
critical financial resources that can be devoted to improving
their delivery of medical services while maintaining the
highest possible quality of patient care at the same time.
At SterilMed, I am responsible for ensuring the company's
compliance with all reprocessing-related Federal, State, and
local regulations. In particular, it is my responsibility to
ensure compliance with the Federal Food, Drug, and Cosmetic Act
and all medical device-related regulations of the Food and Drug
Administration. As my colleague, Don Selvey, has just
explained, reprocessors are subject to more stringent FDA
regulations than OEMs are.
SterilMed currently has more than 800 full-time and part-
time employees throughout the country. We provide reprocessing
services to approximately 1,400 healthcare facilities
throughout the United States and Canada. We reprocess
approximately 2 million devices per year. In that context,
SterilMed currently saves hospitals over $40 million per year
in device expenditures.
The safety record for reprocessed medical devices is
nothing short of outstanding. Of the tens of thousands of
patient adverse event reports that FDA receives through its
medical device reporting program [MDR] program, only a very
small percentage concern reprocessed single-use devices, and
the few problems that have occurred with reprocessed single-use
devices appear to be quite similar to the types of problems
associated with new devices. Indeed, in a recent letter from
FDA to Chairman Davis regarding MDR reports filed since October
2003, to December 2005, the FDA stated expressly that it did
not identify any adverse events that were actually related to
the reprocessing of the SUD.
A significant body of professional and scientific
literature, much of it from peer review journals, further
supports the conclusion that some single-use devices can safely
be reprocessed. A GAO report confirms the existence of these
studies. Because of the reprocessing industry's exemplary
record of safety, informed hospitals and physicians support the
practice of reprocessing. The GAO interviewed hospital
infection control practitioners, risk management executives,
and patient safety experts and found that they all reported
that proper reprocessing does not pose a risk to patient
health.
Hospitals demand all rigorous safety standards be adhered
to by third party reprocessors. Indeed, SterilMed tests or
inspects every reprocessed device before it is sent out to a
hospital, and this is the practice of the industry as a whole.
This is in contrast to OEMs who we understand typically test
only a small sampling of devices. The result is that some
hospitals say they prefer using reprocessed devices over
original devices because they know that each reprocessed device
has been individually scrutinized.
America's finest medical facilities use reprocessed medical
devices, including 13 of the 14 institutions ranked by U.S.
News and World Report in 2006 as the Nation's Honor Roll of
Hospitals. These institutions include Massachusetts General,
Brigham and Women's University Hospital, the Mayo Clinic, the
Cleveland Clinic, and Johns Hopkins University. It simply makes
no sense that these institutions would put their patients at
risk in order to save money. To the contrary, these facilities
use reprocessed devices because they have studied the issue
thoroughly and have determined that reprocessing is both safe
and cost-effective.
Mr. Chairman, that concludes my testimony. I look forward
to responding to any further questions you might have regarding
these issues.
[The prepared statement of Mr. Toussaint follows:]
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Chairman Tom Davis. Thank you very much.
Mr. Ubl.
STATEMENT OF STEPHEN J. UBL
Mr. Ubl. Good morning, I would like to thank you, Mr.
Chairman, and other members of the committee for holding this
hearing today.
AdvaMed is the world's largest trade association
representing medical technology manufacturers. Our member
companies produce the medical devices, diagnostic products, and
health information systems that are transforming healthcare
through earlier disease detection, less invasive procedures,
and more effective treatments.
I would like to open this morning by clarifying the basic
distinction between devices sold by original equipment
manufacturers, our members, and those by reprocessors. Devices
that our manufacturers sell must be safe and effective. Based
on their design and the data submitted, FDA clears devices
designed for one-time use only as well as other devices
designed for multiple use. Reprocessors, by contrast, take a
device that has been cleared as safe and effective by the FDA
for only one use and, after reprocessing, sell it to be used
again.
There are four primary messages I would like to leave with
the committee about reuse of medical devices.
First, reprocessing a medical device that is designed to be
used once is inherently risky. It is difficult to clean and
sterilize extremely small and structurally complex devices.
Blood, mucous, and fecal material can accumulate during use in
areas that are very difficult to access and clean. In addition,
there can be debilitating effects from initial use, cleaning,
and resterilization on the physical properties of the device.
Materials can become brittle, sticky, or deformed.
Let me illustrate these points with an example, and I think
somebody will bring this to the dais for the Members to review.
This is one of the technologies that was mentioned in earlier
testimony. It is an EP catheter, electrophysiology catheter,
and this technology is threaded through the groin of a patient,
up into the heart to map the heart's electrical impulses in
various parts of the heart to detect abnormalities.
This device has to be rigid enough, stiff enough to
actually be threaded up into the heart, yet it has to be
flexible enough to make sure that it doesn't puncture the
artery and it has to be flexible enough to go through the
twists and turns of the artery. It also has to be sterile so as
not to introduce potential infection, and it has to be
sensitive enough so that when it gets to the heart, it can
accurately take readings from the heart.
Every one of those properties can be negatively affected by
reuse. Failure to completely clean and sterilize the device can
potentially transfer blood-borne diseases from one patient to
another. Cleaning and sterilization and use itself can affect
the device's flexibility, durability, and sensitivity. No one
should want a device used on a second, third, or fourth patient
unless there is an ironclad assurance that it is literally as
good as new after it is reprocessed.
That leads to me to my second point. A reprocessed device
should be held to the same rigorous standard of safety and
effectiveness that FDA applies to original devices.
Third, the recently enacted legislative and regulatory
framework for reprocessed devices is a significant improvement.
However, in our view, the public is still not adequately
protected because only a limited number of reprocessed devices
have been subjected to FDA review. FDA directives require that
reprocessors submit validation data for only 68 or 228 device
types.
Yet in 50 percent of those cases, the reprocessed device
was found to be not substantially equivalent to the original
device or the reprocessor voluntarily withdrew the product due
to lack of adequate validation data. A 50 percent failure rate
is intolerable for any industry, but it is especially
intolerable when it occurs with a device designed to diagnose,
treat, and cure patients. AdvaMed urges FDA to review
validation data for all reprocessed single-use devices.
Fourth, we support the strengthened reporting and branding
provisions in MDUFSA. However, it is still too early to draw
conclusions as to whether these changes will adequately improve
the identification reporting of adverse events associated with
reprocessed devices. As has been mentioned earlier, the new
labeling provision only went into effect in August. Prior to
that date, providers had little ability to identify whether or
not an adverse event was due to a device that had been
reprocessed or one that was not.
In closing, if appropriate regulations means some products
will continue to be reprocessed because the practice is
supported by appropriate validation data, that is acceptable.
If appropriate regulation of reprocessing means some of these
products can no longer be reprocessed, then patient safety will
benefit from that decision.
We look forward to working with the Congress and FDA to
make the promise of MDUFMA a safe reality for millions of
patients. Thank you for the opportunity to address the
committee on this important patient safety issue. I look
forward to answering any questions the committee might have.
[The prepared statement of Mr. Ubl follows:]
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Chairman Tom Davis. Thank you.
Mr. Selvey and Mr. Toussaint, let me just start.
Mr. Selvey, one of the challenges of reprocessing, it seems
to me, has to be the changes to technology and designs. How do
you keep up with the evolving technology and designs when you
are not privy to trade secret information?
Mr. Selvey. Mr. Chairman, if I may?
Chairman Tom Davis. Yes.
Mr. Selvey. There are a couple of things that we can do to
keep up with the changing in design. First off, if the design
change by the original manufacturer is significant, they are
required under law to notify the FDA. That becomes public
information. We can monitor that and, in fact, we become aware
of that.
Chairman Tom Davis. You can then decide if you want to buy
something new at that point to make the decision?
Mr. Selvey. Correct.
The other part would be the change that is made by the
original manufacturer that is not a significant change; we
would pick that up through our routine monitoring of the
devices. Periodically, we will do revalidation of the process
but even beyond that, we will do periodic things like materials
testing, analysis of the devices, just to make sure that there
hasn't been a relatively insignificant change that has not been
reported to the Food and Drug Administration and therefore not
made public.
Chairman Tom Davis. I don't know how I ask this. I guess I
just ask this in a generic sense. How many times can one of the
single-use devices be reprocessed before it becomes unusable?
Does it just depend?
I gather you have a way to look at that and decide if it is
usable or not. How do you decide?
Mr. Selvey. Mr. Chairman, there are a couple of factors
that go into it. Yes, every device does have a finite number of
reprocessing cycles. Typically, for the devices that we
reprocess, it is going to be somewhere between one and five
cycles. The average is about three. We are going to base that
on the studies that we do in order to validate our ability to
clean and test and resterilize the device.
There is also a certain amount of, what I refer to as, the
law of diminishing return. Typically, these devices are
rejected out at about a 20 percent rate. That is, when they
come into us, for whatever reason, about one in five devices is
not fit to go through the process. Therefore, it is in our best
interest to look very carefully at whether we are going to get
more than five cycles out of the device, just based on that
diminishing; typically three times, usually based, well, always
based on the validation studies that we have.
Mr. Ubl. Mr. Chairman, may I comment on that question?
Chairman Tom Davis. You may.
Mr. Ubl. I think it is very, very difficult for
reprocessors to keep up with those changes. Let me just give
you example. This was mentioned earlier. FDA allows
reprocessors to submit in bundles, sometimes covering multiple
manufacturers in the same device in the hundreds. FDA would
never allow original manufacturers to submit and bundle their
applications in that fashion. So I think it is extremely
difficult to essentially assert that these types of products
have the same degree of sameness, if you will, and keep up with
the rapid incremental changes in technology.
Chairman Tom Davis. Mr. Selvey asserts that the
reprocessing is highly regulated and probably more stringently
regulated than the original equipment industry, and you seem to
contradict that.
Mr. Ubl. Yes, I am absolutely baffled by that assertion.
Our information suggests that, in fact, they have a much lower
bar, and part of that is the bundled submission that I
mentioned but, in addition, the quality systems regulation,
pre-clinical testing of individual components, which they
obviously can't do because they don't have the proprietary
information. There is a whole range of FDA regulatory
authorities that apply much more acutely to original
manufacturers than they do to reprocessors.
Chairman Tom Davis. Why don't you guys reprocess your own
stuff?
Mr. Toussaint. Mr. Chairman.
Chairman Tom Davis. I will give you a chance to answer in a
second.
Why don't your own people, your own member companies ever
partner with a reprocessor to refurbish their own devices?
Mr. Ubl. Why don't they? Because they don't----
Chairman Tom Davis. Yes; is it because you make more on
selling new stuff?
Mr. Ubl. Well, they fundamentally don't believe that a
reprocessed device is their device. It is a different product,
and they really question the premise of whether these
technologies can be safely reprocessed.
I have to go back to the comment that was made that this is
about money. Reprocessing single-use devices are less than 5
percent of all device sales, 5 percent. So the assertion that
this all about economics is ludicrous, absolutely ludicrous.
Chairman Tom Davis. But obviously, if you can get this
device to work well, I don't know why you wouldn't want to do
something that costs less. They are getting squeezed every
which way for health costs. If you can reprocess a device and
use it cheaper, why wouldn't you?
Mr. Ubl. Absolutely, and we do it all the time. Let me just
clarify that FDA approves single-use devices and multiple use
devices. Our members make both. Our members are trying to be
responsive to what the patient needs are and what the hospital
and provider needs are. So for example, a trocar is a
technology that used to be made in stainless steel and is now
made in plastic due to the customer demanding ease of use and
disposability. So there is a tension in the marketplace, and we
are trying to be as responsive as possible to providers.
Chairman Tom Davis. But you would admit that if the
reprocessors and the FDA can guarantee patient safety, you
don't have a problem with reprocessing.
Mr. Ubl. We believe that the biggest problem is that a
large number of devices don't come under the FDA purview. Dr.
Schultz actually mentioned two adverse events that we reported
to the FDA that were not being regulated by the FDA's
reprocessing authority.
Chairman Tom Davis. But conceptually, if the FDA regulated
them, even if they made them be single-event pieces, if they
can use them and it is safe, you don't have a problem.
Mr. Ubl. Conceptually, yes; I mean I think we might have
some issues around bundling and some of the mechanics of how it
is done.
Chairman Tom Davis. You are saying if they can assure the
safety, you don't have a problem; OK.
Mr. Selvey, do you want to comment, or Mr. Toussaint?
Mr. Toussaint. Mr. Chairman, I really need to respond to
Mr. Ubl's comment about bundling. I am not sure where he is
getting this, his information, but there is an FDA guidance on
bundling that does apply to, not only to reprocessor but OEMs,
and in that guidance document, it states specifically that it
is appropriate for manufacturers to bundle devices among
generic types of devices, and it defines very specifically what
a generic type of device is. It is appropriate. It further
states that it is appropriate to bundle devices when the
differences do not reflect any changes in safety or
effectiveness of the devices. So bundling is an appropriate
practice.
When we do choose to bundle, we do it very carefully, and
we scrutinize it very carefully. When Mr. Ubl says that
hundreds of devices are not tested, that is simply not correct.
Chairman Tom Davis. Every time there is an adverse
incident, it just hurts your industry, right?
Mr. Toussaint. I am sorry, what?
Chairman Tom Davis. Every time there is an adverse incident
with one of these devices, it just hurts your marketability and
profitability, doesn't it?
Mr. Toussaint. Yes, I would say.
Chairman Tom Davis. So, of course, OK.
Mr. Toussaint. Yes. When we choose to bundle devices,
however, it is not that we choose one device out of, say, 50
devices to test. Within the bundling, within bundling a family,
for instance, all devices are tested, and that way, during the
review process, if the FDA would choose to analyze each device
separately, statistically and otherwise, they could do so.
So in effect, it would become a separate submission. So
bundling is a means to increase the efficiency of FDA review,
and it allows FDA to look at devices individually along with
the family of devices, the generic type of family devices they
belong to.
Chairman Tom Davis. How do you feel about the level of FDA
regulation? Do you think it is about right at this point? Do
you think you are under-regulated or over-regulated?
Mr. Toussaint. Are you speaking to me, Mr. Chairman?
Chairman Tom Davis. I am. I am going to ask all three of
you that.
Mr. Toussaint. About the entire MDUFMA regulation, I think
it is entirely over-regulated. I think many of these devices
that require additional validation were previously cleared in
the year 2000 or even prior to that and contain much of the
data that submissions contain today, and I believe this is
simply that the requirements that are required today of SVS
submissions are a result of the pressure put on OEMs, so we are
not allowed to process devices.
Chairman Tom Davis. Mr. Ubl, you don't agree with that?
Mr. Ubl. I absolutely don't agree. I think the practice is
under-regulated. Again, FDA only regulates 68 types of
technologies out of a possible 228. AdvaMed has provided to the
FDA two types of technologies that have had adverse events
associated with them. They, in turn, have extended their
regulatory umbrella to those types of technologies. We wonder
how many other technologies are out there that are at risk to
patients.
I know for my family, I certainly wouldn't want to trust a
reprocessor to tell me how many uses.
Chairman Tom Davis. Well, let me ask you another question.
Do you think the OEMs are too regulated or not regulated
enough?
Mr. Ubl. I think there are appropriate regulations of
original manufacturers.
Chairman Tom Davis. OK.
Mr. Toussaint. Mr. Chairman, I really need to respond to
one other comment from Mr. Ubl.
Chairman Tom Davis. Now, I am going to get to Mr.
Gutknecht. Sure, we will let you respond. Let me give Mr.
Gutknecht 10 minutes. Go ahead.
Mr. Gutknecht. Well, I just want one real quick question.
If this is so dangerous, you, both Mr. Selvey and Mr.
Toussaint, your product liability or your liability insurance
must be just sky-high.
Mr. Selvey. Mr. Gutknecht, that is an important
distinction. We do carry liability insurance, in fact, at the
same level or an even higher level than some of the original
manufacturers. Although we are not trying to compete with the
manufacturers, we are trying to make our hospital customers
very comfortable with our level of coverage. The reality is
that despite having reprocessed something on the order of 15
million devices since our inception, we have never been sued by
a patient, by a hospital, claiming that we produced an adverse
event in a patient. In a litigious society, I think maybe that
says something.
Mr. Toussaint. I don't know what our insurance rates are at
SterilMed, but I can say the same thing that Mr. Selvey has
said, and that is that we have never been sued by a hospital, a
patient, or had any other litigious event occur against our
company.
Mr. Gutknecht. So it is fair to say that both your
insurance companies and your customers are satisfied with the
quality of the products that you are putting out there.
Mr. Ubl. Can I comment on that, Congressman?
In some ways, reprocessing is flying under the radar. The
reason there haven't been suits by patients or by providers is
because, as has been mentioned by FDA and in my testimony,
there is not adequate branding so that practitioners and
patients even know that a reprocessed device is being used. So,
until we have well-established branding, tracking, reporting,
and so forth, we are not going to know what the true impact is.
Mr. Gutknecht. Well, with all due respect, I have heard
those siren songs before about drugs coming in from Canada, and
the evidence is that a whole lot more Americans die every year
from drugs that are purchased in the United States.
Mr. Ubl. This is very different than a pill, Congressman.
This is coming in contact with blood, tissue, and even the
heart.
Mr. Gutknecht. I understand, and I will reclaim my time,
thank you.
The point really is if this was as dangerous as some would
have us believe, we would have massive lawsuits and, more
importantly, the market for these devices, in my judgment,
would dry up. I have talked to some of my hospital people. I
have talked to some of my doctors about this very issue, and
their general view is this is much ado about very little.
I yield back my time.
Chairman Tom Davis. Mrs. Schmidt.
Mrs. Schmidt. Thank you, Mr. Chairman.
I have a couple of questions for the panel. The first
regards the bundling. I am very concerned about the bundling
because I don't think it allows the FDA to have a clear review
of each and every device. Would you be amenable? Frankly, I am
not concerned about the ease of the FDA doing their job. The
point is we have to have FDA doing the right job.
Would any of you be adverse to not allowing the bundling
and to force the FDA to look at each and every application on
its own merit without bundling these devices?
Mr. Selvey. Mrs. Schmidt, may I take a crack at that?
Bundling is a prime example of much ado about nothing. As
Mr. Toussaint has said, there is an FDA guidance on bundling
for both OEMs and for reprocessors.
But there is a very practical aspect here. When we put
together a 510(k) and it goes to a reviewer who is not used to
seeing bundled submissions, they have not been trained in
bundled submissions, honestly, the reviewer doesn't know what
to do with a bundled submission. We do not put together bundled
submissions. I am not sure what Mr. Ubl is complaining about,
but aside from some of the very early submission that we did
back in the year 2000 that caused much heartburn and grief
among the reviewers at the FDA, we stopped bundling. We haven't
bundled a submission in a very long time.
So to answer your question very directly, we would have no
issue at all with doing away with bundling. It simply is not an
issue for us in this industry.
Mrs. Schmidt. In the matter of time, could I have a yes or
no from either one of you because I have another question?
Mr. Ubl. I am delighted to hear that response. The only
comment that I would make is it is important for the committee
to understand we are not just talking about a family of
technologies made by one manufacturer. What they are bundling
is across manufacturers making a similar product which is why
it is so disturbing to us.
Mr. Toussaint. Mr. Chairman, why that statement is somewhat
incorrect is after each family, even though we bundle across
families, for each family we provide separate validation data
on that family. So each family is tested independently. Whether
they are bundled together in a single submission or in multiple
submissions, they still undergo the same review process.
Mrs. Schmidt. Mr. Chairman, another question; one of my
other concerns is the ability for the patient to know whether
they are getting an original product or a reused product. Would
any of you; just a yes or no answer with no comment, be in
agreement that in the future, if it is a reused product, the
patient will know up-front that it is going to be used, yes or
no?
Mr. Selvey. No.
Mr. Toussaint. No.
Mr. Cummings. Yes, we would support patient informed
consent.
Mrs. Schmidt. OK, thank you very much.
Mr. Toussaint. Mr. Chairman.
Chairman Tom Davis. Yes, go ahead.
Mr. Toussaint. I have another comment I feel I must address
by Mr. Ubl, and that was his comment regarding the 50 percent
rate as being totally unobjectionable as devices not being safe
enough and effective. I am not sure where that rate comes from,
but I believe it is a total distortion of facts. I believe that
rate comes from the fact that when reprocessors originally had
to submit SVSes on a number of products, we received a number
of NFC determinations or requests for additional information.
This in no way implied that the devices were not safe and
effective.
In fact, let me read to you a quote from an FDA colleague
about this matter. Larry Spears, the Deputy Director of the
Office of Compliance at the FDA Center for Devices and
Radiological Health stated that any reference to the specific
devices that can no longer be legally marketed as being
dangerous or unsafe is incorrect. Although some devices were
found through review by our Office of Device Evaluation to be
non-substantially equivalent to a previously marketed device,
this does not mean they are unsafe or ineffective.
Mr. Ubl. Mr. Chairman.
Mr. Toussaint. When you receive an NFC letter, that is a
request by FDA that you need to submit further information,
further validation data, or other information. It does not mean
that the devices at that point cannot be deemed substantially
equivalent. During that period of time, many SVS submissions
were submitted to FDA, and FDA was working through the process
as well as the manufacturer. So it is not unexpected that we
would receive NFC letters and FDA would be, would send out such
letters and ask for additional information.
There are other factors that relate to that 50 percent
figure. It may be simply that the manufacturer chose not, after
receiving such a letter, decided, chose not to provide that
additional information because it was too, not feasibly cost-
effective.
Mr. Ubl. I promise to be really quick, Mr. Chairman, but
let us just look at FDA's testimony to this committee. They say
33 percent of the time when the reprocessor submits their
application, it was not substantially equivalent. That means it
is taken off the shelf. I will grant you that it seems like
approval rates have improved since we have been using the 50
percent rate, but a third of the time, they are submitting
applications that are not meeting the test by FDA. This, to us,
tells us that not only should they be looking at the devices
they are looking at now but the additional types of
technologies that are currently under FDA's purview.
Chairman Tom Davis. All right; anything else?
Mr. Toussaint. No; I would just like to respond to that
comment as well.
Chairman Tom Davis. Go ahead and get going. Go ahead.
Mr. Toussaint. Just that the 33 percent simply means that
we need to provide additional validation data. It doesn't mean
the devices are not substantially equivalent, nor does it mean
that----
Mr. Ubl. Does it mean they are off the shelf?
Chairman Tom Davis. Is this stuff properly categorized so
you know how many times it has been used, just for the record,
as you keep it, or do you just examine it and say, yes, this
looks good?
Mr. Toussaint. I am sorry. I didn't understand the
question.
Chairman Tom Davis. Every time you reuse a medical device,
is it logged in that this is the third time or the fourth time
or the second time it has been used, or do you just kind of
look at it and decide if it meets criteria or not?
Mr. Toussaint. I would say we generally look at it and
decide if it meets criteria.
Chairman Tom Davis. So it is not necessarily logged in, and
you have that record of how many times it is has been used?
Mr. Toussaint. Well, we certainly have. You are talking
about specific devices?
Chairman Tom Davis. Yes.
Mr. Toussaint. Certainly, we have a record of how many
times a device has been used.
Chairman Tom Davis. Anything else?
We are going to vote, and I want to let the panel go.
This is to be continued. Obviously, we don't have a
consensus here, but I appreciate everybody's testimony and
being able to make the case. The committee will continue to
look at this further.
Thank you.
[Whereupon, at 12:17 p.m., the committee was adjourned.]
[The prepared statement of Hon. Edolphus Towns follows:]
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