[Federal Register Volume 75, Number 79 (Monday, April 26, 2010)]
[Notices]
[Pages 21641-21642]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-9208]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0204]
Infusion Pumps; Public Meeting; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting; request for comments.
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SUMMARY: The Food and Drug Administration (FDA) is announcing a public
meeting regarding external infusion pumps. The purpose of the meeting
is to inform the public about current problems associated with external
infusion pump use, to help the agency identify quality assurance
strategies to mitigate these problems, and to solicit comments and
input regarding how to bring more effective external infusion pumps to
market. Elsewhere in this issue of the Federal Register, FDA is
announcing the availability of a draft guidnace document entitled
``Total Product Life Cycle: Infusion Pump--Premarket Notification
(510(k)) Submissions.''
Date and Time: The public meeting will be held on May 25 and 26,
2010, from 8 a.m. to 5 p.m. Persons interested in attending the meeting
must register by 5 p.m. on May 18, 2010.
Location: The public meeting will be held at the Hilton Silver
Spring hotel, 8727 Colesville Rd., Silver Spring, MD 20910. Seating is
limited and available only on a first-come, first-served basis.
Contact Person: Victoria Wagman, Food and Drug Administration,
Center for Devices and Radiological Health (CDRH), 10903 New Hampshire
Ave., Bldg. 66, rm. 5449, Silver Spring, MD 20993-0002, 301-796-6851,
e-mail: [email protected].
Registration: Register online for webinar or onsite attendance at
http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm203299.htm (select the appropriate meeting from the list). Please
provide complete contact information for each attendee, including name,
title, affiliation, address, e-mail, and telephone number. Registration
requests should be received by May 18, 2010. For those without Internet
access, please call 301-796-6861 to register. Registration is free and
will be on a first-come, first-served basis. Early registration is
recommended because seating is limited and therefore FDA may limit the
number of participants from each organization. If time and space
permits, onsite registration on the day of the public meeting will be
provided beginning at 7 a.m. Persons needing a sign language
interpreter or other special accommodations should notify Victoria
Wagman (see Contact Person) at least 7 days in advance. Additional
information is also available at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm181140.htm.
Comments: Regardless of attendance at the public meeting,
interested persons may submit written or electronic comments. 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://www.regulations.gov. 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. Please also indicate the specific question(s)
addressed. (See section II 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.
SUPPLEMENTARY INFORMATION:
[[Page 21642]]
I. Background
FDA has seen an increase in the number and severity of external
infusion pump incident reports and recalls. During the period from
January 1, 2005, to December 31, 2009, FDA received over 56,000 medical
device reports associated with the use of external infusion pumps. Of
these reports, approximately 1 percent reported deaths, 34 percent
reported serious injuries, and 62 percent reported malfunctions. The
most frequently reported external infusion pump device problems across
all of the adverse reports recieved included software error messages,
human factors (which include but are not limited to use error), broken
components, battery failure, alarm failure, over infusion, and under
infusion. In some reports, the manufacturer was unable to determine or
identify the problem, however, subsequent analyses revealed that many
of the problems were preventable.
FDA has evaluated a broad spectrum of infusion pumps across
manufacturers and has concluded there are numerous, systemic problems
with device design, manufacturing, and adverse event reporting. To
address these problems, the agency determined that manufacturers may
need to conduct additional assessments of new products or make changes
to products currently being marketed.
II. Topics for Discussion at the Public Meeting
At the meeting, CDRH will discuss how to improve the safety and
efficacy of external infusion pumps and hear input on these issues from
a broad range of stakeholders. The agency encourages individuals,
patient advocates, industry, consumer groups, health care
professionals, researchers, and other interested persons to attend the
public meeting. To help focus the agency's strategies, CDRH requests
feedback on the following questions, which will serve as the basis for
discussion at the public meeting:
What problems with external infusion pump have you
observed in the clinical or home setting?
How can FDA, academia, users, patients, and industry work
together to improve the safety and efficacy of infusion pumps?
What factors or criteria should be considered when
designing an external infusion pump for the clinical or home
environment and the user populations in those environments?
Why is it important? What is the best way for FDA to
receive timely, accurate, and complete adverse events reports?
When changes to CDRH's pre- or postmarket regulation of
external infusion pumps are warranted, how should the center apply them
to devices currently under review?
How could CDRH better communicate external infusion pump
issues or concerns to its stakeholders?
During the meeting, there will be a facilitated discussion between
CDRH staff and invited experts from the private and public sectors
about the questions presented in this document, as well as periodic
open sessions allowing all attendees the opportunity to provide comment
and feedback. Information gathered from the public meeting will help
the agency in developing topics for further consideration.
III. Transcripts
Transcripts of the public meeting may be requested in writing from
the Freedom of Information Office (HFI-35), Food and Drug
Administration, 5600 Fishers Lane, rm. 6-30, Rockville, MD 20857,
approximately 15 working days after the public meeting at a cost of 10
cents per page. A link to the transcripts will also be available on the
Internet at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm approximately 45 days after the
meeting.
Dated: April 16, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-9208 Filed 4-23-10; 8:45 am]
BILLING CODE 4160-01-S