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Health and Safety Information 216
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.
r260.book Page 216 Friday, March 18, 2011 11:57 PM