User's Manual Part 3

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 defibrillators from
wireless telephones. This test method is now part of a standard
sponsored by the Association for the Advancement of Medical
instrumentation (AAMI). The final draft, a joint effort 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 defibrillators 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 specifies test methods and performance
requirements for hearing aids and wireless phones so 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.
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