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sold devices that claimed to protect wireless phone users from radiation with making false and unsubstantiated claims.
According to FTC, these defendants lacked a reasonable basis to substantiate their claim.
11. What about wireless phone interference with medical equipment?
Radiofrequency energy (RF) from wireless phones can interact with some electronic devices. For this reason, FDA helped
develop a detailed test method to measure electromagnetic interference (EMI) of implanted cardiac pacemakers and
debrillators from wireless telephones. This test method is now part of a standard sponsored by the Association for the
Advancement of Medical Instrumentation (AAMI). The nal draft, a joint eort by FDA, medical device manufacturers, and
many other groups, was completed in late 2000. This standard will allow manufacturers to ensure that cardiac pacemakers
and debrillators are safe from wireless phone EMI.
FDA has tested hearing aids for interference from handheld wireless phones and helped develop a voluntary standard
sponsored by the Institute of Electrical and Electronic Engineers (IEEE). This standard species test methods and
performance requirements for hearing aids and wireless phones so that that no interference occurs when a person uses a
compatible“ phone and a compatible“ hearing aid at the same time. This standard was approved by the IEEE in 2000.
FDA continues to monitor the use of wireless phones for possible interactions with other medical devices. Should harmful
interference be found to occur, FDA will conduct testing to assess the interference and work to resolve the problem.
Updated July 29, 2003
For more information, please visit the FDA website at http://www.fda.gov/cellphones.
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