Food and Drug Administration, HHS.
Notice of public meeting; request for comments.
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: firstname.lastname@example.org.
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.End Preamble Start Supplemental Information
SUPPLEMENTARY INFORMATION:Start Printed Page 21642
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.
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.Start Signature
Dated: April 16, 2010.
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-9208 Filed 4-23-10; 8:45 am]
BILLING CODE 4160-01-S