Federal Register / Vol. 71, No. 155 / Friday, August 11, 2006 / Notices 46233 

on the nature of the requests made for 

presentations. 

III. Will Meeting Transcripts Be 

Available? 

Following the meeting, transcripts 

will be available for review at the 

Division of Dockets Management (see 

ADDRESSES). 

IV. How Should You Send Comments 

on the Issues? 

Interested persons may submit written 

or electronic comments to the Division 

of Dockets Management (see 

ADDRESSES). Submit a single copy of 

electronic comments or two paper 

copies of any mailed comments, 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: August 1, 2006. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 06–6867 Filed 8–8–06; 3:14 pm] 

BILLING CODE 4160–01–S 

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. 

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://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://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 


hsrobinson on PROD1PC67 with NOTICES1
46234 Federal Register / Vol. 71, No. 155 / Friday, August 11, 2006 / Notices 

1RFID refers to a wireless communication 

technology that uses radio frequency signals to 

capture data from a tag that can identify and track 

objects. 

2At 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). 

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. 

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 procode2); 

• 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://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 


hsrobinson on PROD1PC67 with NOTICES1
Federal Register / Vol. 71, No. 155 / Friday, August 11, 2006 / Notices 46235 

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 


hsrobinson on PROD1PC67 with NOTICES1
46236 Federal Register / Vol. 71, No. 155 / Friday, August 11, 2006 / Notices 

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://www.fda.gov/cdrh/ocd/ 

uidevices061405.html), April 14 and 15, 

2005. 

4. ECRI/FDA White Paper: Automatic 

Identification of Medical Devices, (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://www.fda.gov/ 

cdrh/ocd/uidevices011606.html), October 27, 

2005. 

6. ‘‘ERG Final Report: Unique 

Identification for Medical Devices,’’ (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://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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

Periodically, the Health Resources 

and Services Administration (HRSA) 

publishes abstracts of information 

collection requests under review by the 

Office of Management and Budget 

(OMB), in compliance with the 

Paperwork Reduction Act of 1995 (44 

U.S.C. Chapter 35). To request a copy of 

the clearance requests submitted to 

OMB for review, call the HRSA Reports 

Clearance Office on (301) 443–1129. 

The following request has been 

submitted to the Office of Management 

and Budget for review under the 

Paperwork Reduction Act of 1995: 

Proposed Project: Assessment of the 

Engagement of Historically Black 

Colleges and Universities in Campus 

and Community-Based Activities to 

Eliminate Health Disparities (NEW) 

The Health Resources and Services 

Administration (HRSA) plans to 

conduct a survey of 525 university 

administrators at Historically Black 

Colleges and Universities (HBCUs) to 

collect information not otherwise 

available about the extent to which 

HBCUs have engaged in health 

promoting activities on campus and in 

their surrounding communities that are 

designed to eliminate health disparities 

among African Americans. The results 

of this survey will be used by HRSA’s 

Office of Minority Health and Health 

Disparities (OMHHD) to obtain 

information regarding the engagement of 

HBCUs in health disparities activities. 

The results of the survey will also 

permit OMHHD (1) to describe the 

origins, structure, content, and intensity 

of such activities, (2) to document the 

level of support for campus and 

community activities among 

administrative leaders at HBCUs, (3) to 

document the factors that facilitate or 

hinder the ability of HBCUs to engage in 

campus and community activities to 

eliminate health disparities, and (4) to 

determine whether there is a need 

among HBCUs for additional assistance 

that will allow them to expand their role 

and improve their effectiveness in 

addressing health disparities. 

The survey process will include a 

web-based survey to be completed by 

targeted respondents. Follow-up 

telephone calls will be conducted with 

respondents who do not complete the 

online survey. Approximately 5 

administrators will be surveyed at each 

of the 105 recognized HBCUs. The types 

of administrators to be surveyed include 

Presidents, Deans of Faculty, Deans of 

Students, and staff and/or faculty that 

are leaders for programs that are 

associated with eliminating health 

disparities. 

The burden estimate for this project is 

as follows: 

Form No. of respondents 

Responses 

per 

respondent 

Total 

responses 

Hours per 

response 

Total burden 

hours 

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

Written comments and 

recommendations concerning the 

proposed information collection should 

be sent within 30 days of this notice to: 

John Kraemer, Human Resources and 

Housing Branch, Office of Management 

and Budget, New Executive Office 

Building, Room 10235, Washington, DC 

20503. 

Dated: August 8, 2006. 

Cheryl R. Dammons, 

Director, Division of Policy Review and 

Coordination. 

[FR Doc. E6–13217 Filed 8–10–06; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Council on Graduate Medical 

Education; Notice of Meeting 

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). 


hsrobinson on PROD1PC67 with NOTICES1