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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.
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) International Commission on Non-
lonizing Radiation Protection (http://www.icnirp.de) World Health
Organization (WHO) International EMF Project
(http://www.who.int/emf) National Radiological Protection Board (UK)
(http://www.nrpb.org.uk/)
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