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Safety Guidelines
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
46
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/cdrh/
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