[Federal Register: September 22, 2006 (Volume 71, Number 184)]
[Notices]
[Page 55491-55493]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22se06-108]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 2006N-0292]
Unique Device Identification; Notice of Public Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting and vendor display.
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SUMMARY: The Food and Drug Administration (FDA) is announcing a public
meeting and vendor display to discuss the issues associated with the
development, implementation, and use of a unique device identification
(UDI) system and the use of various automatic identification
technologies. We are inviting individuals, companies, organizations,
and other stakeholders to attend this public meeting, which will focus
on the development and implementation of a UDI system; the benefits and
costs of a UDI system; the use of automatic identification
technologies; and the development, maintenance, and use of a repository
for UDI related information. We are also inviting vendors of automatic
identification technologies to display their products for the
educational benefits of FDA and other attendees.
DATES AND TIMES: The public meeting will be held on Wednesday, October
25, 2006, from 9 a.m. to 4 p.m. Registration to attend the meeting, to
present at the meeting, and to participate in the vendor display must
be received by October 10, 2006. Submit written comments by November 9,
2006.
You may register electronically at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/ocd/udi/index.html
(see SUPPLEMENTARY INFORMATION, section V of this document
for information on registration.
ADDRESSES: The public meeting will be held at the Gaithersburg Marriott
Washingtonian Center, 9751 Washingtonian Blvd., Gaithersburg, MD 20878,
1-301-590-0044.
A block of rooms is being held for the evening of Tuesday, October
24, 2006. Please mention the ``FDA UDI Meeting'' when calling the
hotel.
Submit written comments 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.
All comments should be identified with the docket
number found in brackets in the heading of this document.
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
If you need special accommodations due to a disability, please
contact Ann Marie Williams at 301-827-7291 at least 7 days in advance
of the meeting.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of 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
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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
have asked that we revisit the issue of bar coding medical devices to
improve patient safety, improve quality of care, and encourage cost
effectiveness of health care, e.g., by improving delivery and supply
chain efficiency. In response to this, FDA met with various
stakeholders, including device manufacturers and distributors, hospital
associations, and other Federal agencies to solicit information and
comments about employing a uniform system for the unique identification
of medical devices.
As a result of these meetings, FDA has learned that the majority of
stakeholders support the development of a uniform system of unique
identifiers as a way to improve patient safety and recognize 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.
We therefore published a notice in the Federal Register of August 11,
2006 (71 FR 46233) (http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/OHRMS/DOCKETS/98fr/06-6870.pdf)
requesting comments by November 9, 2006, to help the agency understand
how the use of a unique device identification system could improve
patient safety, for example, by reducing medical errors, facilitating
device recalls, and improving medical device adverse event reporting.
We are now announcing a public meeting to further discuss the issues
around UDI and the use of various automatic identification
technologies.
II. Meeting Format
The meeting will be divided into four sessions, each one focused on
one of the four main topic areas (described in section III of this
document (Scope of Discussion)). Each session will begin with an
invited presentation to describe the issue and will be followed by a
moderated discussion with an invited representative panel. Following
this discussion, the moderator will open up the discussion to questions
and comments on the topic from the audience. Though limited, at the end
of the day there will be time for other presentations.
III. Scope of Discussion
We will hold a public meeting on October 25, 2006, from 9 a.m. to 4
p.m. to discuss the development, implementation, and use of a unique
device identification system. We anticipate discussions among an
invited panel and other members of the public on these issues and we
intend to focus on these main areas and the following specific
questions:
A. The Benefits and Costs of a UDI System
1. What public health and patient safety benefits could be gained
from having a standardized UDI system? How would such a system
contribute to meeting device recall and adverse event reporting
requirements, and to reducing medical error?
2. What are the setup costs measured in time and other resources
associated with the development, implementation, and use of a UDI
system? 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?
B. Design and Implementation of a System of UDI
1. How should a UDI system be developed? What attributes or
elements of a device should be used to create the UDI? Should unique
device identifiers be considered for all devices? At what unit of
packaging (that is, unit of use) should UDIs be considered (for
example, the unit of use could be a box of examination gloves or an
infusion pump)? Should UDIs be considered for different levels of
packaging?
2. What are the incentives for establishing a uniform, standardized
system of UDIs? What are the barriers for establishing UDIs? What
suggestions would you have for overcoming these barriers?
C. The Development, Maintenance, and Use of a Repository for UDI-
related Information
1. What is the minimum data set that should be associated with a
UDI? Would this minimum data set differ for different devices? What
other data would improve patient safety?
2. 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?
D. The Use of Automatic Identification Technologies
1. Should the UDI be both human readable and encoded in an
automatic identification technology? Should a UDI be based on the use
of a specific technology (e.g., linear bar code) or be nonspecific?
2. If a bar code is recommended, is a specific type of symbology
preferred? Should the bar code be ``compatible''' with those used for
the drug bar code rule? Should the UDI be on the device itself (e.g.,
laser-etched) for certain devices?
IV. Vendor Display
There will be no fee for participating in the vendor display. For
the purposes of this meeting, we are only interested in displays from
vendors of automatic identification technologies that can be used to
identify medical devices. At the time of registration, you will be
asked to submit a short summary of your product. We can accommodate 15
vendors at this meeting. When vendor registration reaches this number,
additional vendor display registrants will be placed on a wait-list. If
you have been placed on the wait-list, we will notify you by e-mail or
telephone if you become confirmed. There will be no onsite registration
for vendors. Each vendor will be provided with a 6-foot tabletop space.
Please note that Internet access will not be available.
One purpose of this meeting is to gain greater understanding of
various automatic identification technologies. Therefore, we are
inviting manufacturers and organizations that market or have in
development automatic identification technologies, which could be used
with medical devices, to display these technologies. Questions about
whether your product or technology would fall within the scope of this
vendor display should be directed to the contact persons (see FOR
FURTHER INFORMATION CONTACT).
V. Registration
Registration is necessary if you would like to present at the
meeting or participate in the vendor display. Registration is also
necessary to attend the meeting and vendor display because space is
limited.
You may register to present at the meeting or participate in the
vendor display at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/ocd/udi/index.html, no later than
October 10, 2006. The registration form will instruct you as to the
information you should
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provide (such as name, address, telephone number, e-mail address,
whether you wish to make a presentation or participate in the vendor
display and how to provide FDA with a summary of your presentation or
product).
You may register to attend the meeting at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/ocd/udi/index.html.
Seating is limited to 300 persons, and if capacity is
reached, registration will close. If you register as a presenter or to
participate in the vendor display, you do not need to also register as
an attendee.
Because of time constraints, vendors may register either to present
at the meeting or participate in the vendor display. You may not
register for both. If you choose to participate in the vendor display,
you will have the opportunity to share information about your products
with the FDA and other attendees when they visit your display.
Because of the format of the meeting, we will only have a short
time for additional presentations. We encourage attendees to raise
their issues and concerns during the discussion portion of the four
main topic areas. We also encourage persons and groups having similar
interests to consolidate their information and present it through a
single representative. By October 16, 2006, we will schedule each
presentation and, by e-mail or telephone, notify each participant who
will present of the time allotted to the person and the approximate
time the person's presentation is scheduled to begin. The time allotted
for presentations may be between 5 to 15 minutes, depending on the
number of people who wish to present. Confirmed presenters need to send
final electronic presentations in Microsoft PowerPoint, Microsoft Word,
or PDF by October 20, 2006 to CDRHUDI@fda.hhs.gov.
VI. Transcripts
The meeting will be transcribed and will be available on the
Internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/ocd/udi/index.html. You may also request a
copy of the transcript by writing to our Freedom of Information Office
(HFI-35), Food and Drug Administration, 5600 Fishers Lane, rm. 12A-16,
Rockville, MD 20857. We anticipate that transcripts will be available
approximately 10 days after the public meeting at a cost of 10 cents
per page. The transcripts will also be available for public examination
at the Division of Dockets Management (HFA-305), 5630 Fishers Lane, rm.
1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through
Friday.
Dated: September 15, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 06-7969 Filed 9-21-06; 8:45 am]
BILLING CODE 4160-01-S