Safety Guidelines
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
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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/
Radiation-EmittingProducts/
RadiationEmittingProductsandProcedures/
HomeBusinessandEntertainment/
CellPhones/default.htm)
Federal Communications Commission
(FCC)
RF Safety Program
(http://www.fcc.gov/oet/rfsafety)
International Commission on Non-
lonizing Radiation Protection (http://
www.icnirp.de)