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Safety Guidelines
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 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)
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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