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(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.
