Post

Labeling for Electronic Anti-Theft Systems to Alert Implantable Medical Device Wearers

This guidance recommends manufacturers of electronic anti-theft systems to develop and implement labeling or signage for both new and currently installed systems to alert implant wearers of their presence, due to potential electromagnetic interference (EMI) with implantable electronic medical devices.

  1. Develop appropriate labeling and signage for all electronic anti-theft systems
  2. Review current installations and provide signage for existing systems
  3. Implement visible warning systems before monitored areas
  4. Update product documentation to include required labeling materials
  5. Establish process for providing signage to facilities with installed systems
  6. Maintain collaboration with retail industry and medical community
  7. Monitor and report any interference incidents with implantable devices
  8. Include appropriate warning labels with all new equipment shipments
  9. Train installation teams on proper signage placement requirements
  10. Maintain records of locations where signage has been provided and installed

Key Considerations

Human Factors

  • Labeling or signage should be positioned to be visible before an individual enters the monitored area
  • Consider both visible monitoring elements (e.g., towers) and concealed systems (installed in walls or ceiling)

Labelling

  • Must include clear indication of system presence using phrases such as “ELECTRONIC ANTI-THEFT SYSTEM IN USE” or “ELECTRONIC SECURITY SYSTEM IN USE”
  • Labels should be affixed to visible monitoring elements
  • Signage should be provided for both visible and concealed monitoring elements
  • Include labeling and signage with all new equipment
  • Provide signage for facilities with currently installed systems

Safety

  • Address potential EMI risks with implantable electronic medical devices
  • Consider reported effects including changes in stimulation rate, level, and mode
  • Account for potential patient effects ranging from unconsciousness to pain

Other considerations

NO_SPECIFIC_REFERENCES_MENTIONED


Original guidance

  • Labeling for Electronic Anti-Theft Systems to Alert Implantable Medical Device Wearers
  • HTML / PDF
  • Issue date: 2000-08-15
  • Last changed date: 2020-03-18
  • Status: FINAL
  • Official FDA topics: Medical Devices, Labeling, Premarket
  • ReguVirta summary file ID: d6bc8fadcc9772c2f9de430a7898cacc
This post is licensed under CC BY 4.0 by the author.