Updated 7/12: Additional slide presentations are available.
- Federal Register Notice
- Date, Time, and Location
- Slides and Transcripts
- Overview of Planned Topics of Discussion
- Contact Us
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
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
Video presentations are available in Windows Media format. Transcripts are also available.
- May 25th
- May 26th
- Individual Presentations (PDF)
- LCDR Mary E. Brooks, RN, BSN, MS
- Richard Chapman - "Assurance Cases For External Infusion Pumps"
- Maria Cvach, MS, RN, CCRN - "Infusion Pump Issues"
- Valerie A. Flournoy - "Medical Device Recalls"
- Michael Fraai, M.S., CCE - Infusion Pump Workshop
- Ron Kaye, MA - "Human Factors / Usability for Infusion Pumps: Additional Test Data Requested In New Draft Guidance"
- Bisi Lawuyi - "Therapeutic Products Directorate"
- Jim Lefever - "Infusion Device Incidents"
- Mary Logan, JD, CAE - AAMI
- Mats Ohlson, MPA - "Infusion Devices"
- Alan Ravitz and Peter Doyle - "JHAPL-JHSOM P5S Project: Public Private Partnership to Promote Patient Safety"
- Nat Sims, MD - "Conceptual Framework for an Improved Drug Infusion Pump Standard"
- LCDR Alan Stevens
- Al Taylor - "Infusion Pump Design Deficiencies"
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
May 25 - Day 1
|7:00am||Registration Opens for Conference|
|7:00am – 8:00am||Registration|
|8:00am – 8:20 am||Welcome Remarks|
|8:20am – 10:20 am|
Defining the problem
|10:20 am – 10:35 am||Break|
|10:35am – 11:00 am||Q & A|
|11:00 am – 12:30 pm||User Perspective|
|12:30 pm – 1:45 pm||Lunch on your own|
|1:45 pm – 2:45 pm||International Perspective|
|2:45 pm - 3:00 pm||Break|
|3:00 pm – 4:00 pm|
|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Overview of TPLC External Infusion Pump Draft Guidance
|10:15 am – 10:30 am||Break|
|10:30 am - 12:00 pm|
Overview of TPLC External Infusion Pump Draft Guidance (continued)
|12:00 am – 1:00 pm||Q & 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)
|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|
For further information about this meeting, contact:
Center for Devices and Radiological Health
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Bldg. 66, rm. 5567
Silver Spring, MD 20993