[Federal Register Volume 75, Number 79 (Monday, April 26, 2010)]
[Pages 21641-21642]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-9208]



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.


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.


[[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 

    Dated: April 16, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-9208 Filed 4-23-10; 8:45 am]