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U.S. Department of Health and Human Services

Medical Devices

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Public Meeting: Infusion Pump Workshop, May 25-26, 2010

Updated 7/12: Additional slide presentations are available.



Federal Register Notice

FDA has published a notice in the Federal Register announcing a public meeting on May 25-26, 2010, and requesting comments on a number of questions regarding infusion pumps.

Please see Docket No. FDA-2010-N-0204

Date, Time and Location

The meeting was held on May 25-26, 2010, from 8:00 a.m. to 5:30 p.m. at the following location:

Hilton Silver Spring
8727 Colesville Rd.
Silver Spring MD 20910

Slides and Transcripts

Video presentations are available in Windows Media format. Transcripts are also available. 

Overview of Planned Topics of Discussion

As described in the Federal Register Notice, the objective of this public meeting is to discuss key challenges related to the infusion pumps, focusing on the following areas: (A) issues commonly related to external infusion pumps; (B) issues reporting Medical Device Reporting (MDRs); (C) issues related to human factors; and (D) issues related to improving the pre and postmarket regulatory process

Agenda

May 25 - Day 1

7:00amRegistration Opens for Conference
7:00am – 8:00amRegistration
8:00am – 8:20 amWelcome Remarks
8:20am – 10:20 am

Defining the problem

  • Overview
    • Analysis of Adverse Events
    • Recall Analysis
    • Identify Current Problems and Device Failures
10:20 am – 10:35 am Break
10:35am – 11:00 amQ & A
11:00 am – 12:30 pmUser Perspective
12:30 pm – 1:45 pm Lunch on your own
1:45 pm – 2:45 pmInternational Perspective
2:45 pm - 3:00 pm Break
3:00 pm – 4:00 pm

Industry Perspective

  • Advanced Medical Technology Association (AdvaMed)
  •  Association for the Advancement of Medical Instrumentation (AAMI)
4:00pm – 4:45 pm Q & A
4:45 pm – 5:00 Day 1 Summary

May 26 - DAY 2

7:00am – 8:00 am Registration
8:00 am – 10:15am

Overview of TPLC External Infusion Pump Draft Guidance

  •  TPLC Guidance Overview
  •  Assurance Cases
10:15 am – 10:30 am Break
10:30 am - 12:00 pm

Overview of TPLC External Infusion Pump Draft Guidance (continued)

  •  Risk Management
  •  Human Factors / Clinical Assessment
12:00 am – 1:00 pmQ & A
1:00 pm – 2:15 pm Lunch on your own
2:15 pm - 3:15 pm

Overview of TPLC External Infusion Pump DraftGuidance (continued)

  •  Pre-Clearance Inspection
  •  MDR Reporting
3:15 pm - 3:45 pm Break
3:45 pm - 4:45 pm Q&A
4:45 pm – 5:00 pm Summary of Days 1 and 2

Contact Us

For further information about this meeting, contact:

Victoria Wagman
Center for Devices and Radiological Health
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Bldg. 66, rm. 5567
Silver Spring, MD 20993
301-796-6581
e-mail: victoria.wagman@fda.hhs.gov