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U.S. Department of Health and Human Services

Medical Devices

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Medical Device Use in the Home Environment Guidance Workshop, May 24, 2010 - Breakout Session Notes: Post Market

Facilitator: Susan Gardner FDA
Scribe: Janette Collins-Mitchell

  • Audience: Mostly Industry

How can we capture information about devices not he market to minimize hazards?

  • What can industry do to improve devices on the postmarket end
  • How to monitor the safety of devices in the home
    • Connect to all customer
  • Specific steps to monitor device safety in the home
    • Sign-up track software for defect
    • Create avenue to secure good quality data
    • Communicate AEs to manufacturers
  • FDA should determine the group that can provide quality data
    • Issues of daily living is magnified with devices in the home
  • FDA to make clear when to report and what to report, who should report and when to report
  • The quality of the report can be influenced by
    • Missing information (i.e. consumer ID; detail of instrument operation and the problem)
    • The consumers’ only concern is their disease not the function of the device
    • Consumer lack of knowledge of HIPPA reporting
  • Guidance should highlight different avenue to get information to patients
    • Regulatory
    • Home Health Agencies
    • Labeling
    • Trained healthcare providers––define and specify training necessary
  • Electronic Reporting
    • Permanent not on Serial number
    • True outcome
    • Establish early baseline
    • Provide data log to track for trending; can be reconstructed to access more information
  • UDI––complete the tracking of product from manufacturer to patient
  • FDA assumption is that all devices will eventually migrate into the home
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