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11. What about wireless phone
interference with medical
equipment?
Radiofrequency energy (RF) from
wireless phones can interact
with some electronic devices.
For this reason, the 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
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.
Safety Guidelines