Medical Device Use in the Home Environment Workshop: Implications for the Safe and Effective Use of Medical Device Technology Migrating Into the Home, May 24, 2010

• Overview
• Date, Time and Location
• Agenda and Presentations
• Attendee List
• Transcripts and Notes
• Contact Us

Overview

Workshop Objective and Format:

The purpose of this workshop is to solicit information from primary and secondary health care providers, academia, human factors experts, industry, medical device distributors, manufacturers, professional societies, patient advocate groups and patients on the challenges surrounding medical device technology in the home environment.

The format for the meeting will include a general session in the morning. The presentations in this session will provide topics for the breakout groups centered around 1.) risks in the home environment 2.) end users in the home environment, and 3.) postmarket tracking of medical devices in the home that will meet in the afternoon. Each breakout session will begin with an invited presentation to describe the issues of concern in the specific specialty, which will be followed by a question and comment session. Breakout group participation will be limited by space and will be available on a first-come, first-served basis. At the conclusion of the day’s breakout group discussions, the general session will reconvene to report to the general session the results of the discussions related to the general topics discussed in each group.

This workshop was organized to discuss the following objectives:

Our current working definition of “home use” as a medical device intended for users in a non-clinical or transitory environment, is managed partly or wholly by the user, requires adequate labeling for use, and may require training by a licensed health care provider in order to be used safely and effectively

The unique risks in the home environment that need to be factored into device design

The unique characteristics of end users in the home environment that need to be factored into device design

The challenges, limitations, and solutions to tracking medical devices in the home for purposes of safety notices and recalls

What users want to see in labeling to help them understand and use their device safely in the home

Date, Time and Location

The meeting was held on May 24, 2010 (7:30 a.m. to 5:00 p.m.) at the following location:

Hilton in Silver Spring
8727 Colesville Road
Silver Spring, MD 20910

Agenda and Presentations

Attendee List

Transcripts and Notes

• Transcripts
  • Transcript Part 1
  • Transcript Part 2
  • Breakout Session Transcript
• Breakout Session Notes
  • Patient Labeling
  • Physical Environment
  • Post Market
  • Wireless Issues
  • Human Factors

Contact Us

The workshop organizer may be contacted at:

Ian Chan
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Avenue WO-66-3313
Silver Spring, MD 20993
Email: ian.chan@fda.hhs.gov (preferable)
Phone: 301-796-6658