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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.
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/
phones/index.html)
Federal Communications
Commission (FCC) RF Safety
Program
(http://www.fcc.gov/oet/rfsafety)
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