User guide

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making false and unsubstantiated claims. According to FTC, these
defendants lacked a reasonable basis to substantiate their claim.
What about wireless phone interference with
medical equipment?
Radio frequency energy (RF) from wireless phones can interact with
some electronic devices. For this reason, FDA helped develop a detailed
test method to measure 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 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. FDA has tested 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.
FDA continues to monitor the use of wireless phones for possible
interactions with other medical devices. Should harmful interference be
found to occur, FDA will conduct testing to assess the interference and
work to resolve the problem.
Additional information on the safety of RF exposures from various
sources can be obtained from the following organizations:
• FCC RF Safety Program:
http://www.fcc.gov/oet/rfsafety/
• Environmental Protection Agency (EPA):
http://www.epa.gov/radiation/