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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: Wireless Issues

Wireless Issues for Home Care Medical Devices

What should go into guidance?

Using GPS in devices

Having device information downloaded from the device to a web application

FDA’s position on ISO 80,000 (80211)

EMC and standards

Telehealth/Environmental Health Issues in the home

Are we seeing more use of wireless technology in the home?

FTC National Broadband Plan has a component that deals with health care.

More and more people are giving up their Lan lines which has implications for transmitting data back to the physician; many people travel to different countries which can be challenging as different countries have different phone systems which can create a challenge for some medical devices (pacemakers)

More interest in seeing wellness applications in mobile devices; questions about the regulatory requirements

When does the telephone become a medical device because it is transmitting medical data

What points should the agency focus on regarding wireless issues?

  1. Reference the medical device wireless guidance
  2. Should we redefine the term medical device? Where is the distinction between a medical device and one that just transmits data?
    • If a device just has an algorithm and a sensor then it is more likely to be seen as a medical device; however if it is just transmitting information then should it be considered a medical device?
  3. Where is the burden of proof that a product is a medical device?
  4. How to validate the communication system? Should we reference part 11?
  5. Cognitive Technology
  6. Is there a possibility of establishing a test environment for home use devices?
  7. Should we try to define what the characteristics of a wireless device should be? Should this information be included in a separate guidance? Should we define what should be in the guidance by the level of risk associated with the device?
  8. Should alerts be built into devices to let the monitor know that the device is actually working and transmitting data? How do we deal with power outages? Are cellular systems to the point where we can consider them reliable enough to deliver home care?
  9. The guidance document should not just look at cellular communication, but at other wireless set ups
  10. It may not be realistic to consider that every user will be able to set up and use wireless devices at home, but lay users could “plug into” into some small part of the device and still use a wireless device in some way.
  11. Make a distinction between monitoring and using the device.
  12. Wireless Security – the secure transmission of data; what is the level of security that you have on the signal? How well can you control it? Systems should be set up to avoid intrusion; ensuring the communication pathway
  13. Data integrity
  14. Labeling specific for wireless technology
  15. Remote Access into a device for trouble shooting; wireless technology enables this capability
  16. If there is post market situation would that might exclude it from being used wirelessly that should be a part of the guidance.
  17. The FCC has mandatory standards regarding wireless technologies; FDA standards are consensus standards they are not mandatory
  18. If this devices causes interference with some other device or product that information should be in the labeling
  19. Future possibility - Body area networks – a system that would be implanted, body worn-24 hour monitoring of a patient
  20. Small number of devices that use a dedicated spectrum for medical devices
  21. Do we need to revisit this yearly given the amount of change that happens in a given year? Is this worth working on this given the time it takes to get a guidance published? Is there another process that we might use other than guidance so that we can get the information out quickly, while it’s still useful
  22. Would this new technology ever require clinical testing?