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reason, the FDA helped develop a detailed test method to
measure Electro Magnetic Interference (EMI) of implanted
cardiac pacemakers and defibrillators from wireless devices.
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 communications device EMI.
The FDA has tested hearing aids for interference from
handheld wireless devices 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 communications devices so that no interference
occurs when a person uses a “compatible” device 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
communications devices 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.
The FDA continues to monitor the use of wireless devices 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:
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.hpa.org.uk/radiation/)