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41
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 the 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. The 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. The
FDA continues to monitor the use of wireless
phones for possible interactions with other
medical devices. Should harmful interference
be found to occur, the FDA will conduct testing
to assess the interference and work to resolve
the problem.
12. Where can I find additional
information?
For additional information, please refer to
the following resources: FDA web page on
wireless phones (http://www.fda.gov/) Federal
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