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.
What You Need to Know? 👇
What are the FDA’s labeling requirements for electronic anti-theft systems in retail environments?
The FDA recommends that manufacturers develop labeling or signage stating “ELECTRONIC ANTI-THEFT SYSTEM IN USE” or “ELECTRONIC SECURITY SYSTEM IN USE” to be posted on or near all new and installed systems to alert implant wearers.
How do electronic anti-theft systems interfere with implanted medical devices?
Electronic anti-theft systems produce electromagnetic radiation that can affect implantable devices like pacemakers, neurological stimulators, and defibrillators. Effects include changes in stimulation rate, level, or mode, though most interactions are transient and mild.
What is the “don’t linger, don’t lean” recommendation for patients with implanted devices?
This recommendation advises patients with implanted electronic medical devices to avoid lingering around or leaning against electronic anti-theft systems to minimize potential electromagnetic interference that could affect their device’s function.
How many adverse events have been reported from anti-theft system interference with medical implants?
The FDA received 63 reports over 10 years describing electromagnetic interference to implantable devices, with 49 specifically caused by anti-theft, electronic article surveillance, or security systems. Most interactions were moderate or mild.
Where should warning labels be positioned on electronic anti-theft systems?
Labels should be positioned so they are visible before an individual enters the monitored area. For visible systems like towers, labels can be affixed directly. For concealed systems, signage should be posted nearby.
What collaborative efforts exist between the anti-theft industry and medical community regarding EMI issues?
The Technical Electronic Products Radiation Safety Standards Committee (TEPRSSC) brings together government agencies, anti-theft industry, and medical community in public forums to research problems and identify solutions for reducing EMI risks.
What You Need to Do 👇
Recommended Actions
- Develop appropriate labeling and signage for all electronic anti-theft systems
- Review current installations and provide signage for existing systems
- Implement visible warning systems before monitored areas
- Update product documentation to include required labeling materials
- Establish process for providing signage to facilities with installed systems
- Maintain collaboration with retail industry and medical community
- Monitor and report any interference incidents with implantable devices
- Include appropriate warning labels with all new equipment shipments
- Train installation teams on proper signage placement requirements
- 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
- Consider collaborative efforts with retail industry and medical community
- Recognize that interference risk is low but should be addressed due to increasing numbers of implant wearers
Relevant Guidances đź”—
- Device Labeling Requirements and Content for Premarket Approval Applications
- Medical Device Reporting (MDR) Requirements and Procedures for Manufacturers
Related references and norms đź“‚
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