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Section 12: Health and Safety Information 187
Consumer Information on Wireless Phones
Section 12
defendants lacked a reasonable basis to substantiate their
claim.
What about wireless phone interference with
medical equipment?
Radio frequency 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 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.