[Federal Register: August 11, 2006 (Volume 71, Number 155)]
[Notices]
[Page 46233-46236]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11au06-78]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N-0292]
Unique Device Identification; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; request for comments.
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SUMMARY: The Food and Drug Administration (FDA) is issuing this notice
to request comments to help the agency understand how the use of a
unique device identification (UDI) system may improve patient safety,
e.g., by reducing medical errors, facilitating device recalls, and
improving medical device adverse event reporting. We are also
interested in understanding the issues associated with the use of
various automatic identification technologies (e.g., bar code,
radiofrequency identification). We invite comments about specific UDI
issues for medical devices.
DATES: Submit written or electronic comments by November 9, 2006.
ADDRESSES: Submit written comments concerning this document to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic
comments to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.
FOR FURTHER INFORMATION CONTACT: David Racine or Jay Crowley, Center
for Devices and Radiological Health (HFZ-500), Food and Drug
Administration, 1350 Piccard Dr., Rockville, MD 20850, 240-276-3400, e-
mail: CDRHUDI@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
On February 26, 2004, we published a final rule (the ``bar code
rule'') (69 FR 9120 ) requiring bar codes on certain human drug and
biological products to help reduce medication errors in hospitals and
other health care settings. The bar code is intended to enable health
care professionals to use bar code scanning equipment in conjunction
with computerized medication administration systems to verify that the
right drug, in the right dose, is being given to the right patient at
the right time. This rule (now codified at 21 CFR 201.25 and 610.67)
requires that manufacturers encode the unique National Drug Code (NDC)
number in a linear bar code on the product's label.
The bar code rule, however, does not apply to medical devices. In
the bar code rule, we stated that, unlike drugs, medical devices do not
have a standardized, unique identifying system comparable to the NDC
number, and that the absence of such a system complicates efforts to
put bar codes on medical devices for purposes of preventing medical
errors (69 FR 9120 at 9132).
Since the issuance of the final bar code rule, various entities,
including members of Congress and a consortium of hospital groups, have
asked that we revisit the issue of bar coding medical devices to
improve patient safety; improve quality of care; and encourage cost
effectiveness, e.g., of health care by improving delivery and supply
chain efficiency (Refs. 1 and 2).
A. Stakeholder Meetings
In response to the interest in revisiting the issue of bar coding
medical devices, FDA met with various stakeholders, including device
manufacturers and distributors, hospital associations, and other
Federal agencies such as the Agency for Healthcare Research and
Quality, Department of Defense, Department of Veterans Affairs, and
Centers for Medicare and Medicaid Services to solicit information and
comments about employing a uniform system for the unique identification
of medical devices. (References 3 and 5 contain summaries of some of
these meetings). We were interested in hearing views about the value of
a uniform system of unique identifiers for medical devices, what
efforts or initiatives are currently ongoing among stakeholders, and
the use of various automatic identification technologies. We were also
interested in FDA's role related to the establishment and use of a UDI
system and whether FDA should consider a voluntary or a mandatory
approach for such a system.
As a result of these meetings, FDA learned that the majority of
stakeholders support the development of a uniform system of unique
identifiers as a way to improve patient safety and recognized other
ancillary benefits such as better management of the purchase,
distribution, and use of medical devices. However, there were a variety
of opinions and experiences about how best to implement such a system.
B. Report on Automatic and Unique Identification of Medical Devices
In addition to holding stakeholder meetings, we commissioned two
reports from outside experts to provide: A general overview of some of
the most prevalent technologies available to support automatic
identification of medical devices, the current published positions and
standards of various stakeholders, and highlights of some of the
general applications reported in the literature involving the use of
such systems for medical devices. (See Refs. 4 and 6 and http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/ocd/udi/
). The reports identified several potential
benefits to widespread use of UDI, such as reducing medical errors,
facilitating recalls, improving medical device reporting, and
identifying incompatibility with devices or potential allergic
reactions. The reports further indicated that many issues have to be
addressed prior to successful implementation of UDI for devices,
including determining the technology needed to utilize UDI effectively,
identifying the data needed for patient safety; development,
maintenance, and validation of a central data repository; and
harmonizing UDIs for the international marketplace.
II. UDI Development and Implementation
We are interested in receiving comment on the possible role that a
unique device identification system could have on improving patient
safety, for example, by reducing medical errors, facilitating device
recalls, and improving medical device adverse event reporting. In
addition, we are interested
[[Page 46234]]
in receiving comments on the feasibility, benefits, and costs involved
in the development and implementation of such a system and views on
FDA's role in such a process.
A. Development of a Unique Device Identification System
The agency believes that unique device identification would entail
creating a uniform, standard system of device attributes--which, when
combined, would uniquely identify a particular device at the unit of
use. The definition of ``unit of use'' would likely vary for different
device types--for example, unit of use could be a box of examination
gloves or an infusion pump. The device attributes or elements of a
unique identifier could include:
Manufacturer, make, and model;
Unique attributes (e.g., size, length, quantity, software
version); and
Serial number, identifying lot number, manufacturing, or
expiration date (depending on the device type).
We envision that a change to any of the above criteria would likely
necessitate a new UDI. For example, different size or length catheters
of the same type would need different (unique) UDIs. Then, taken
together, for example--if the Acme Company manufactured different types
and styles of examination gloves in various sizes and quantities--the
elements of the UDI might include:
[1 - manufacturer] Acme (manufacturer number 12345)
[2 - make and model] Great Latex Examination Gloves (product number
6789)
[3 - size] Adult large (size number 012)
[4 - how packaged] Box of 50 (quantity number 50)
[5 - lot number] Lot number: 6789 (lot number 6789)
When these elements or attributes are combined together--the result
is a number which would uniquely identify all lots of those specific
gloves. The UDI might then look like:
[1] 12345 [2] 6789 [3] 012 [4] 50 [5] 6789
This UDI is human readable and could be listed on device labeling.
The UDI could also be encoded in any of a number of different automatic
identification technologies (e.g., barcode, radiofrequency
identification (RFID))\1\--depending on the stakeholders' needs and
uses. Though the number does not necessarily have any inherent meaning,
it could be used to reference more information about the device.
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\1\ RFID refers to a wireless communication technology that uses
radio frequency signals to capture data from a tag that can identify
and track objects.
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B. Implementing Unique Device Identification
We believe that the UDI could be used in two broad ways. First, the
UDI itself would represent a way to uniquely identify a specific device
(or, for example, a lot of the same device). The UDI could be used to
specifically identify a particular device--for example, to facilitate
reporting an adverse event or locating a recalled device.
Second, the UDI may be used to convey information to promote safe
device use. The UDI could interface with a computer database that could
access an additional reference data set with information related to
safe use (such as indications for use and accessories needed to operate
the device). For example, a UDI could be used to convey any or all of
the following information as part of a minimum data set:
Manufacturer, make, and model;
Unique attributes (e.g., size, length, quantity, software
version); and
Serial number, identifying lot number, manufacturing, or
expiration date (depending on the device type).
Product type (and identifying code, such as FDA
procode\2\);
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\2\ At the time that new medical devices are cleared or approved
by FDA, the agency assigns them a product code (or ``procode''),
which is a general classification scheme and is used for FDA
listings of types of devices. Manufacturers are required to use this
system for identifying devices on all MDR reports they send to FDA
(including reports they forward from user facilities).
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Indications for use, contraindications, warning,
precautions;
The accessories needed to operate the device; and
If the device is an accessory to another device, the
specific device with which it operates.
This information could reside in a publicly available database,
such as the National Library of Medicine's DailyMed (http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://dailymed.nlm.nih.gov/
)--which currently provides information about
marketed drugs, including FDA approved labels. The information from
this website is available electronically and is both easier for people
to read and ``computer friendly.'' As such, it is intended to be the
basis for populating computer systems and provide users up to date
information. The agency requests comment on whether some or all of the
information in the minimum data set, described previously, would
improve patient safety, and if so, how. If not, why not?
C. The Use and Benefits of UDIs
We believe that the use of UDI could bring about a number of
patient safety benefits, including reducing medical errors,
facilitating device recalls, and improving medical device adverse event
reporting.
D. Reducing Medical Error
Device-related medical errors are a common and serious problem. The
November 1999 Institute of Medicine report, ``To Err is Human--Building
a Safer Health System,'' estimated that as many as 98,000 people die in
any given year from medical errors that occur in hospitals. Incorrect
medical device use represents a category of medical device related
error. For example, while all implants are intended to be sterilized
before use, some of these devices are shipped sterile and some are
shipped nonsterile because the hospital plans to sterilize the implant
itself prior to use. Shipping both sterile and nonsterile implants
could lead to difficulties at the hospital due to errors in
distinguishing between the sterile and nonsterile implants. UDI
information and its associated labeling data could be automatically
read and help users distinguish between sterile and nonsterile
products. This could prevent the possibility that a patient would
receive a nonsterile implant.
Another example is when devices, which are not designed or intended
to be used together, are erroneously used together. The UDI system
could be used to improve interoperability issues, such as identifying
the specific accessories to be used with a medical device. A UDI could
also identify compatibility issues--such as those devices which can be
used safely with magnetic resonance imaging (MRI) systems.
E. Facilitating Device Recalls
An effective system of device identification could improve various
postmarket efforts. Currently, locating all devices subject to a recall
is a time and labor intensive process. Manufacturers, distributors and
healthcare facilities often do not know exactly where all recalled
devices are located. Consequently, the failure to identify recalled
devices could result in the continued use of such devices on patients
in a variety of settings (e.g. hospitals, long-term care facilities,
homecare environments) and cause increased risk for patient harm.
Moreover, it is usually not possible to associate the use of a device
with a particular patient. The UDI could facilitate identifying
patients who have
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been exposed to or received the recalled device.
F. Improving Adverse Event Reporting
Present adverse event reporting systems do not usually capture the
specific device used, or overall device use (referred to as
``denominator data''). UDI could facilitate identification of devices
in adverse event reports, in the use of active surveillance systems,
and provide better documentation of specific medical device use in
electronic health records and health databases. This would allow us
both to identify new problems and also establish a denominator of
device use, so that the incidence of adverse events related to the
overall device use can be better quantified.
G. Ancillary Benefits
In addition to improved patient safety from reducing medical
errors, facilitating device recalls, and improving adverse event
reporting, there may be secondary or ancillary benefits from the use of
a UDI. These benefits include improved materials management and
associated healthcare cost savings. UDIs could also facilitate the
development of useful electronic health records by allowing providers
to automatically capture important information about the device that
has been used on a patient. UDIs could help identify similar devices or
devices that are substantially equivalent if there were concerns that
recalls or other problems with marketed devices might create a
shortage. The use of UDIs could also reduce the potential for injury
from counterfeit devices by offering a better way to track devices and
detect counterfeit product.
III. Agency Request for Information
In light of the potential benefits highlighted previously, FDA is
interested in gathering information about the feasibility, utility,
benefits, and costs associated with the development and implementation
of a UDI system for medical devices. We are also interested in
understanding the issues associated with the use of various automatic
identification technologies (e.g., bar code, RFID). Therefore, we
invite comments and available data on the following questions:
Developing a System of Unique Device Identifiers
1. How should a unique device identification system be developed?
What attributes or elements of a device should be used to create the
UDI?
2. What should be the role, if any, of FDA in the development and
implementation of a system for the use of UDIs for medical devices?
Should a system be voluntary or mandatory?
3. What are the incentives for establishing a uniform, standardized
system of unique device identifiers?
4. What are the barriers for establishing unique device
identifiers? What suggestions would you have for overcoming these
barriers?
5. Have you implemented some form of UDI in your product line?
Please describe the extent of implementation, type of technology used,
and the data currently provided.
6. Should unique device identifiers be considered for all devices?
If yes, why? If not, what devices should be considered for labeling
with a UDI and why?
7. At what level of packaging (that is, unit of use) should UDIs be
considered? Should UDIs be considered for different levels of
packaging? If yes, should the level of packaging be based on the type
of device? Why or why not?
8. What solutions have you developed or could be developed for
addressing the technological, equipment, and other problems that might
arise in developing and implementing a UDI system (e.g., solutions for
packaging issues)?
Implementing Unique Device Identifiers
9. What is the minimum data set that should be associated with a
unique device identifier? Would this minimum data set differ for
different devices? If so, how? How would the data in the minimum data
set improve patient safety? What other data would improve patient
safety?
10. How should the UDI and its associated minimum data set be
obtained and maintained? How and by whom should the UDI with its
associated minimum data set be made publicly available?
11. Should the UDI be both human readable and encoded in an
automatic technology? Should the UDI be on the device itself (e.g.,
laser-etched) for certain devices?
12. Should a UDI be based on the use of a specific technology
(e.g., linear bar code) or be nonspecific? Please explain your
response. If a bar code is recommended, is a specific type of symbology
preferred, and if so, what type and why? Should the bar code be
``compatible'' with those used for the drug bar code rule? If yes, why?
If not, why not?
UDI Benefits and Costs
13. From your perspective, what public health and patient safety
benefits could be gained from having a standardized unique device
identifier system? How would such a system contribute to meeting device
recall and adverse event reporting requirements, and to reducing
medical error? Please submit detailed data to support benefits you
identify.
14. From your perspective, what are the setup costs measured in
time and other resources associated with the development,
implementation, and use of a UDI system? Please submit detailed data to
support these cost estimates.
15. If you have already implemented a form of unique identification
on your medical device labeling, what investments in equipment,
training, and other human and physical resources were necessary to
implement the use of UDIs? What factors influenced your decision to
implement such a system? What changes in patient safety or economic
benefits and costs have you observed since the institution of UDIs?
16. From your perspective, what is the expected rate of technology
acceptance in implementing or using a UDI system?
17. From your perspective, what are the obstacles to implementing
or using a UDI system in your location?
18. For hospitals and other device user facilities considering
technology investments, what would be the relative priority of
developing UDI capabilities compared to other possible advancements,
such as Electronic Health Records, bedside barcoding for
pharmaceuticals dispensing, data sharing capabilities across hospitals
and other device user facilities, and other possible advances?
19. What infrastructure or technological advancements are needed
for hospitals and other device user facilities to be able to capture
and use UDI for basic inventory control and recall completion purposes?
How costly are these advancements?
20. Referring specifically to completing medical device recalls in
your hospital or other device user facility, for what share of the most
serious (Class I) or next most serious (Class II) recalls would having
access to and an ability to capture UDI information help you to
respond?
IV. References
The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen between
9 a.m. and 4 p.m.., Monday through Friday. (FDA has verified the Web
site address, but is not responsible for subsequent changes to the Web
site after this document publishes in the Federal Register.)
1. Letter from Pete Sessions, Mike Doyle, Tim Murphy, Michael
Conaway, Bill Jenkins, Bob Inglis, George Radarovich, Members of
[[Page 46236]]
Congress to Lester M. Crawford, Acting Commissioner, Food and Drug
Administration, dated May 24, 2005.
2. Letter from Margaret Reagan (Premiere, Inc.), Rick Pollack
(American Hospital Association), Larry Gage (National Association of
Public Hospitals and Health Systems), Charles Kahn (Federation of
American Hospitals), Edward Goodman (Veterans Health
Administration), Michael Rodgers (Catholic Health Association of the
United States), Robert Dickler (Association of American Medical
Colleges) to Lester Crawford, Acting Commissioner, Food and Drug
Administration, dated May 9, 2005.
3. The Food and Drug Law Institute/CDRH Report on Meeting to
Discuss Unique Device Identification, (http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/ocd/uidevices061405.html
), April 14 and 15, 2005.
4. ECRI/FDA White Paper: Automatic Identification of Medical
Devices, (http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/ocd/ecritask4.html), August 17,
2005.
5. The Food and Drug Law Institute/CDRH, ``Report on Meeting to
Discuss Unique Device Identification,'' (http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/ocd/uidevices011606.html
), October 27, 2005.
6. ``ERG Final Report: Unique Identification for Medical
Devices,'' (http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/ocd/udi/erg-report.html), March
22, 2006.
7. ``Ensuring the Safety of Marketed Medical Devices: CDRH's
Medical Device Safety Program,'' (http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/postmarket/mdpi-report.pdf
), January 18, 2006.
V. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic copies or two paper copies of any
mailed comments are to be submitted, except that individuals may submit
one paper copy. Comments are to be identified with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday.
Dated: July 27, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 06-6870 Filed 8-9-06; 8:45 am]
BILLING CODE 4160-01-S