You are on page 1of 4

Federal Register / Vol. 71, No.

155 / Friday, August 11, 2006 / Notices 46233

on the nature of the requests made for 5630 Fishers Lane, rm. 1061, Rockville, medical devices. (References 3 and 5
presentations. MD 20852. Submit electronic comments contain summaries of some of these
to http://www.fda.gov/dockets/ meetings). We were interested in
III. Will Meeting Transcripts Be
ecomments. hearing views about the value of a
Available?
FOR FURTHER INFORMATION CONTACT: uniform system of unique identifiers for
Following the meeting, transcripts medical devices, what efforts or
David Racine or Jay Crowley, Center for
will be available for review at the initiatives are currently ongoing among
Devices and Radiological Health (HFZ–
Division of Dockets Management (see stakeholders, and the use of various
500), Food and Drug Administration,
ADDRESSES). automatic identification technologies.
1350 Piccard Dr., Rockville, MD 20850,
IV. How Should You Send Comments 240–276–3400, e-mail: We were also interested in FDA’s role
CDRHUDI@fda.hhs.gov. related to the establishment and use of
on the Issues?
a UDI system and whether FDA should
Interested persons may submit written SUPPLEMENTARY INFORMATION: consider a voluntary or a mandatory
or electronic comments to the Division approach for such a system.
I. Background
of Dockets Management (see As a result of these meetings, FDA
ADDRESSES). Submit a single copy of On February 26, 2004, we published learned that the majority of stakeholders
electronic comments or two paper a final rule (the ‘‘bar code rule’’) (69 FR support the development of a uniform
copies of any mailed comments, except 9120 ) requiring bar codes on certain system of unique identifiers as a way to
that individuals may submit one paper human drug and biological products to improve patient safety and recognized
copy. Comments are to be identified help reduce medication errors in other ancillary benefits such as better
with the docket number found in hospitals and other health care settings. management of the purchase,
brackets in the heading of this The bar code is intended to enable distribution, and use of medical devices.
document. Received comments may be health care professionals to use bar code However, there were a variety of
seen in the Division of Dockets scanning equipment in conjunction opinions and experiences about how
Management between 9 a.m. and 4 p.m., with computerized medication best to implement such a system.
Monday through Friday. administration systems to verify that the
right drug, in the right dose, is being B. Report on Automatic and Unique
Dated: August 1, 2006. Identification of Medical Devices
given to the right patient at the right
Jeffrey Shuren, time. This rule (now codified at 21 CFR In addition to holding stakeholder
Assistant Commissioner for Policy. 201.25 and 610.67) requires that meetings, we commissioned two reports
[FR Doc. 06–6867 Filed 8–8–06; 3:14 pm] manufacturers encode the unique from outside experts to provide: A
BILLING CODE 4160–01–S National Drug Code (NDC) number in a general overview of some of the most
linear bar code on the product’s label. prevalent technologies available to
The bar code rule, however, does not support automatic identification of
DEPARTMENT OF HEALTH AND apply to medical devices. In the bar medical devices, the current published
HUMAN SERVICES code rule, we stated that, unlike drugs, positions and standards of various
medical devices do not have a stakeholders, and highlights of some of
Food and Drug Administration standardized, unique identifying system the general applications reported in the
[Docket No. 2006N–0292] comparable to the NDC number, and literature involving the use of such
that the absence of such a system systems for medical devices. (See Refs.
Unique Device Identification; Request complicates efforts to put bar codes on 4 and 6 and http://www.fda.gov/cdrh/
for Comments medical devices for purposes of ocd/udi/). The reports identified several
AGENCY: Food and Drug Administration, preventing medical errors (69 FR 9120 potential benefits to widespread use of
HHS. at 9132). UDI, such as reducing medical errors,
Since the issuance of the final bar facilitating recalls, improving medical
ACTION: Notice; request for comments. code rule, various entities, including device reporting, and identifying
SUMMARY: The Food and Drug members of Congress and a consortium incompatibility with devices or
Administration (FDA) is issuing this of hospital groups, have asked that we potential allergic reactions. The reports
notice to request comments to help the revisit the issue of bar coding medical further indicated that many issues have
agency understand how the use of a devices to improve patient safety; to be addressed prior to successful
unique device identification (UDI) improve quality of care; and encourage implementation of UDI for devices,
system may improve patient safety, e.g., cost effectiveness, e.g., of health care by including determining the technology
by reducing medical errors, facilitating improving delivery and supply chain needed to utilize UDI effectively,
device recalls, and improving medical efficiency (Refs. 1 and 2). identifying the data needed for patient
device adverse event reporting. We are safety; development, maintenance, and
A. Stakeholder Meetings
also interested in understanding the validation of a central data repository;
In response to the interest in and harmonizing UDIs for the
issues associated with the use of various
revisiting the issue of bar coding international marketplace.
automatic identification technologies
medical devices, FDA met with various
(e.g., bar code, radiofrequency II. UDI Development and
stakeholders, including device
identification). We invite comments Implementation
manufacturers and distributors, hospital
about specific UDI issues for medical
associations, and other Federal agencies We are interested in receiving
devices.
such as the Agency for Healthcare comment on the possible role that a
hsrobinson on PROD1PC67 with NOTICES1

DATES: Submit written or electronic Research and Quality, Department of unique device identification system
comments by November 9, 2006. Defense, Department of Veterans Affairs, could have on improving patient safety,
ADDRESSES: Submit written comments and Centers for Medicare and Medicaid for example, by reducing medical errors,
concerning this document to the Services to solicit information and facilitating device recalls, and
Division of Dockets Management (HFA– comments about employing a uniform improving medical device adverse event
305), Food and Drug Administration, system for the unique identification of reporting. In addition, we are interested

VerDate Aug<31>2005 15:03 Aug 10, 2006 Jkt 208001 PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 E:\FR\FM\11AUN1.SGM 11AUN1
46234 Federal Register / Vol. 71, No. 155 / Friday, August 11, 2006 / Notices

in receiving comments on the any inherent meaning, it could be used C. The Use and Benefits of UDIs
feasibility, benefits, and costs involved to reference more information about the
in the development and implementation device. We believe that the use of UDI could
of such a system and views on FDA’s bring about a number of patient safety
B. Implementing Unique Device benefits, including reducing medical
role in such a process. Identification errors, facilitating device recalls, and
A. Development of a Unique Device We believe that the UDI could be used improving medical device adverse event
Identification System in two broad ways. First, the UDI itself reporting.
The agency believes that unique would represent a way to uniquely D. Reducing Medical Error
device identification would entail identify a specific device (or, for
creating a uniform, standard system of example, a lot of the same device). The Device-related medical errors are a
device attributes—which, when UDI could be used to specifically common and serious problem. The
combined, would uniquely identify a identify a particular device—for November 1999 Institute of Medicine
particular device at the unit of use. The example, to facilitate reporting an report, ‘‘To Err is Human—Building a
definition of ‘‘unit of use’’ would likely adverse event or locating a recalled Safer Health System,’’ estimated that as
vary for different device types—for device. many as 98,000 people die in any given
example, unit of use could be a box of Second, the UDI may be used to year from medical errors that occur in
examination gloves or an infusion convey information to promote safe hospitals. Incorrect medical device use
pump. The device attributes or elements device use. The UDI could interface represents a category of medical device
of a unique identifier could include: with a computer database that could related error. For example, while all
• Manufacturer, make, and model; access an additional reference data set implants are intended to be sterilized
• Unique attributes (e.g., size, length, with information related to safe use before use, some of these devices are
quantity, software version); and (such as indications for use and shipped sterile and some are shipped
• Serial number, identifying lot accessories needed to operate the nonsterile because the hospital plans to
number, manufacturing, or expiration device). For example, a UDI could be sterilize the implant itself prior to use.
date (depending on the device type). used to convey any or all of the Shipping both sterile and nonsterile
We envision that a change to any of following information as part of a implants could lead to difficulties at the
the above criteria would likely minimum data set: hospital due to errors in distinguishing
• Manufacturer, make, and model; between the sterile and nonsterile
necessitate a new UDI. For example, • Unique attributes (e.g., size, length,
different size or length catheters of the implants. UDI information and its
quantity, software version); and
same type would need different • Serial number, identifying lot associated labeling data could be
(unique) UDIs. Then, taken together, for number, manufacturing, or expiration automatically read and help users
example—if the Acme Company date (depending on the device type). distinguish between sterile and
manufactured different types and styles • Product type (and identifying code, nonsterile products. This could prevent
of examination gloves in various sizes such as FDA procode2); the possibility that a patient would
and quantities—the elements of the UDI • Indications for use, receive a nonsterile implant.
might include: contraindications, warning, precautions; Another example is when devices,
[1 - manufacturer] Acme (manufacturer • The accessories needed to operate which are not designed or intended to
number 12345) the device; and be used together, are erroneously used
[2 - make and model] Great Latex • If the device is an accessory to together. The UDI system could be used
Examination Gloves (product number another device, the specific device with to improve interoperability issues, such
6789) which it operates. as identifying the specific accessories to
This information could reside in a be used with a medical device. A UDI
[3 - size] Adult large (size number 012) publicly available database, such as the could also identify compatibility
[4 - how packaged] Box of 50 (quantity National Library of Medicine’s issues—such as those devices which can
number 50) DailyMed be used safely with magnetic resonance
[5 - lot number] Lot number: 6789 (lot (http://dailymed.nlm.nih.gov/)—which imaging (MRI) systems.
number 6789) currently provides information about
When these elements or attributes are marketed drugs, including FDA E. Facilitating Device Recalls
combined together—the result is a approved labels. The information from
An effective system of device
number which would uniquely identify this website is available electronically
identification could improve various
all lots of those specific gloves. The UDI and is both easier for people to read and
postmarket efforts. Currently, locating
might then look like: ‘‘computer friendly.’’ As such, it is
all devices subject to a recall is a time
[1] 12345 [2] 6789 [3] 012 [4] 50 [5] intended to be the basis for populating
and labor intensive process.
6789 computer systems and provide users up
Manufacturers, distributors and
This UDI is human readable and to date information. The agency requests
healthcare facilities often do not know
could be listed on device labeling. The comment on whether some or all of the
exactly where all recalled devices are
UDI could also be encoded in any of a information in the minimum data set,
located. Consequently, the failure to
number of different automatic described previously, would improve
identify recalled devices could result in
identification technologies (e.g., patient safety, and if so, how. If not,
the continued use of such devices on
barcode, radiofrequency identification why not?
patients in a variety of settings (e.g.
(RFID))1—depending on the hospitals, long-term care facilities,
hsrobinson on PROD1PC67 with NOTICES1

2 At the time that new medical devices are cleared


stakeholders’ needs and uses. Though homecare environments) and cause
or approved by FDA, the agency assigns them a
the number does not necessarily have product code (or ‘‘procode’’), which is a general increased risk for patient harm.
classification scheme and is used for FDA listings Moreover, it is usually not possible to
1 RFID refers to a wireless communication of types of devices. Manufacturers are required to
technology that uses radio frequency signals to use this system for identifying devices on all MDR
associate the use of a device with a
capture data from a tag that can identify and track reports they send to FDA (including reports they particular patient. The UDI could
objects. forward from user facilities). facilitate identifying patients who have

VerDate Aug<31>2005 15:03 Aug 10, 2006 Jkt 208001 PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 E:\FR\FM\11AUN1.SGM 11AUN1
Federal Register / Vol. 71, No. 155 / Friday, August 11, 2006 / Notices 46235

been exposed to or received the recalled implementation of a system for the use system? How would such a system
device. of UDIs for medical devices? Should a contribute to meeting device recall and
system be voluntary or mandatory? adverse event reporting requirements,
F. Improving Adverse Event Reporting 3. What are the incentives for and to reducing medical error? Please
Present adverse event reporting establishing a uniform, standardized submit detailed data to support benefits
systems do not usually capture the system of unique device identifiers? you identify.
specific device used, or overall device 4. What are the barriers for 14. From your perspective, what are
use (referred to as ‘‘denominator data’’). establishing unique device identifiers? the setup costs measured in time and
UDI could facilitate identification of What suggestions would you have for other resources associated with the
devices in adverse event reports, in the overcoming these barriers? development, implementation, and use
use of active surveillance systems, and 5. Have you implemented some form of a UDI system? Please submit detailed
provide better documentation of specific of UDI in your product line? Please data to support these cost estimates.
medical device use in electronic health describe the extent of implementation, 15. If you have already implemented
records and health databases. This type of technology used, and the data a form of unique identification on your
would allow us both to identify new currently provided. medical device labeling, what
problems and also establish a 6. Should unique device identifiers be investments in equipment, training, and
denominator of device use, so that the considered for all devices? If yes, why? other human and physical resources
incidence of adverse events related to If not, what devices should be were necessary to implement the use of
the overall device use can be better considered for labeling with a UDI and UDIs? What factors influenced your
quantified. why? decision to implement such a system?
7. At what level of packaging (that is, What changes in patient safety or
G. Ancillary Benefits unit of use) should UDIs be considered? economic benefits and costs have you
In addition to improved patient safety Should UDIs be considered for different observed since the institution of UDIs?
from reducing medical errors, levels of packaging? If yes, should the 16. From your perspective, what is the
facilitating device recalls, and level of packaging be based on the type expected rate of technology acceptance
improving adverse event reporting, of device? Why or why not? in implementing or using a UDI system?
there may be secondary or ancillary 8. What solutions have you developed 17. From your perspective, what are
benefits from the use of a UDI. These or could be developed for addressing the obstacles to implementing or using
benefits include improved materials the technological, equipment, and other a UDI system in your location?
management and associated healthcare problems that might arise in developing 18. For hospitals and other device
cost savings. UDIs could also facilitate and implementing a UDI system (e.g., user facilities considering technology
the development of useful electronic solutions for packaging issues)? investments, what would be the relative
health records by allowing providers to priority of developing UDI capabilities
Implementing Unique Device Identifiers
automatically capture important compared to other possible
information about the device that has 9. What is the minimum data set that advancements, such as Electronic
been used on a patient. UDIs could help should be associated with a unique Health Records, bedside barcoding for
identify similar devices or devices that device identifier? Would this minimum pharmaceuticals dispensing, data
are substantially equivalent if there data set differ for different devices? If sharing capabilities across hospitals and
were concerns that recalls or other so, how? How would the data in the other device user facilities, and other
problems with marketed devices might minimum data set improve patient possible advances?
create a shortage. The use of UDIs could safety? What other data would improve 19. What infrastructure or
also reduce the potential for injury from patient safety? technological advancements are needed
counterfeit devices by offering a better 10. How should the UDI and its for hospitals and other device user
way to track devices and detect associated minimum data set be facilities to be able to capture and use
counterfeit product. obtained and maintained? How and by UDI for basic inventory control and
whom should the UDI with its recall completion purposes? How costly
III. Agency Request for Information associated minimum data set be made are these advancements?
In light of the potential benefits publicly available? 20. Referring specifically to
highlighted previously, FDA is 11. Should the UDI be both human completing medical device recalls in
interested in gathering information readable and encoded in an automatic your hospital or other device user
about the feasibility, utility, benefits, technology? Should the UDI be on the facility, for what share of the most
and costs associated with the device itself (e.g., laser-etched) for serious (Class I) or next most serious
development and implementation of a certain devices? (Class II) recalls would having access to
UDI system for medical devices. We are 12. Should a UDI be based on the use and an ability to capture UDI
also interested in understanding the of a specific technology (e.g., linear bar information help you to respond?
issues associated with the use of various code) or be nonspecific? Please explain
automatic identification technologies your response. If a bar code is IV. References
(e.g., bar code, RFID). Therefore, we recommended, is a specific type of The following references have been
invite comments and available data on symbology preferred, and if so, what placed on display in the Division of
the following questions: type and why? Should the bar code be Dockets Management (see ADDRESSES)
‘‘compatible’’ with those used for the and may be seen between 9 a.m. and 4
Developing a System of Unique Device drug bar code rule? If yes, why? If not, p.m.., Monday through Friday. (FDA has
Identifiers why not?
hsrobinson on PROD1PC67 with NOTICES1

verified the Web site address, but is not


1. How should a unique device responsible for subsequent changes to
identification system be developed? UDI Benefits and Costs
the Web site after this document
What attributes or elements of a device 13. From your perspective, what publishes in the Federal Register.)
should be used to create the UDI? public health and patient safety benefits 1. Letter from Pete Sessions, Mike Doyle,
2. What should be the role, if any, of could be gained from having a Tim Murphy, Michael Conaway, Bill Jenkins,
FDA in the development and standardized unique device identifier Bob Inglis, George Radarovich, Members of

VerDate Aug<31>2005 15:03 Aug 10, 2006 Jkt 208001 PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 E:\FR\FM\11AUN1.SGM 11AUN1
46236 Federal Register / Vol. 71, No. 155 / Friday, August 11, 2006 / Notices

Congress to Lester M. Crawford, Acting identified with the docket number administrators at Historically Black
Commissioner, Food and Drug found in brackets in the heading of this Colleges and Universities (HBCUs) to
Administration, dated May 24, 2005. document. Received comments may be collect information not otherwise
2. Letter from Margaret Reagan (Premiere, seen in the Division of Dockets available about the extent to which
Inc.), Rick Pollack (American Hospital
Association), Larry Gage (National
Management between 9 a.m. and 4 p.m., HBCUs have engaged in health
Association of Public Hospitals and Health Monday through Friday. promoting activities on campus and in
Systems), Charles Kahn (Federation of Dated: July 27, 2006. their surrounding communities that are
American Hospitals), Edward Goodman Jeffrey Shuren, designed to eliminate health disparities
(Veterans Health Administration), Michael Assistant Commissioner for Policy. among African Americans. The results
Rodgers (Catholic Health Association of the of this survey will be used by HRSA’s
United States), Robert Dickler (Association of [FR Doc. 06–6870 Filed 8–9–06; 8:45 am]
Office of Minority Health and Health
American Medical Colleges) to Lester BILLING CODE 4160–01–S
Disparities (OMHHD) to obtain
Crawford, Acting Commissioner, Food and information regarding the engagement of
Drug Administration, dated May 9, 2005.
3. The Food and Drug Law Institute/CDRH DEPARTMENT OF HEALTH AND HBCUs in health disparities activities.
Report on Meeting to Discuss Unique Device HUMAN SERVICES The results of the survey will also
Identification, (http://www.fda.gov/cdrh/ocd/ permit OMHHD (1) to describe the
uidevices061405.html), April 14 and 15, Health Resources and Services origins, structure, content, and intensity
2005. Administration of such activities, (2) to document the
level of support for campus and
4. ECRI/FDA White Paper: Automatic Agency Information Collection community activities among
Identification of Medical Devices, (http:// Activities: Submission for OMB administrative leaders at HBCUs, (3) to
www.fda.gov/cdrh/ocd/ecritask4.html), Review; Comment Request document the factors that facilitate or
August 17, 2005.
5. The Food and Drug Law Institute/CDRH, Periodically, the Health Resources hinder the ability of HBCUs to engage in
‘‘Report on Meeting to Discuss Unique and Services Administration (HRSA) campus and community activities to
Device Identification,’’ (http://www.fda.gov/ publishes abstracts of information eliminate health disparities, and (4) to
cdrh/ocd/uidevices011606.html), October 27, collection requests under review by the determine whether there is a need
2005. Office of Management and Budget among HBCUs for additional assistance
6. ‘‘ERG Final Report: Unique that will allow them to expand their role
Identification for Medical Devices,’’ (http://
(OMB), in compliance with the
Paperwork Reduction Act of 1995 (44 and improve their effectiveness in
www.fda.gov/cdrh/ocd/udi/erg-report.html), addressing health disparities.
March 22, 2006. U.S.C. Chapter 35). To request a copy of
the clearance requests submitted to The survey process will include a
7. ‘‘Ensuring the Safety of Marketed
Medical Devices: CDRH’s Medical Device OMB for review, call the HRSA Reports web-based survey to be completed by
Safety Program,’’ (http://www.fda.gov/cdrh/ Clearance Office on (301) 443–1129. targeted respondents. Follow-up
postmarket/mdpi-report.pdf), January 18, The following request has been telephone calls will be conducted with
2006. submitted to the Office of Management respondents who do not complete the
and Budget for review under the online survey. Approximately 5
V. Comments administrators will be surveyed at each
Paperwork Reduction Act of 1995:
Interested persons may submit to the of the 105 recognized HBCUs. The types
Division of Dockets Management (see Proposed Project: Assessment of the of administrators to be surveyed include
ADDRESSES) written or electronic Engagement of Historically Black Presidents, Deans of Faculty, Deans of
comments regarding this document. Colleges and Universities in Campus Students, and staff and/or faculty that
Submit a single copy of electronic and Community-Based Activities to are leaders for programs that are
copies or two paper copies of any Eliminate Health Disparities (NEW) associated with eliminating health
mailed comments are to be submitted, The Health Resources and Services disparities.
except that individuals may submit one Administration (HRSA) plans to The burden estimate for this project is
paper copy. Comments are to be conduct a survey of 525 university as follows:

Responses
No. of re- Total Hours per Total burden
Form per
spondents responses response hours
respondent

Survey .................................................................................. 525 1 525 .75 394

Written comments and Dated: August 8, 2006. DEPARTMENT OF HEALTH AND


recommendations concerning the Cheryl R. Dammons, HUMAN SERVICES
proposed information collection should Director, Division of Policy Review and
be sent within 30 days of this notice to: Coordination. Health Resources and Services
John Kraemer, Human Resources and [FR Doc. E6–13217 Filed 8–10–06; 8:45 am]
Administration
Housing Branch, Office of Management BILLING CODE 4165–15–P Council on Graduate Medical
and Budget, New Executive Office
Education; Notice of Meeting
Building, Room 10235, Washington, DC
hsrobinson on PROD1PC67 with NOTICES1

20503. In accordance with section 10(a)(2) of


the Federal Advisory Committee Act
(Pub. L. 92–463), notice is hereby given
of the following meeting:
Name: Council on Graduate Medical
Education (COGME).

VerDate Aug<31>2005 15:03 Aug 10, 2006 Jkt 208001 PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 E:\FR\FM\11AUN1.SGM 11AUN1

You might also like