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(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 simultaneously. 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), under “C” in the subject index, select Cell
Phones > Current Research Results. Federal Communications Commission (FCC)
RF Safety Program (http://www.fcc.gov/cgb/cellular.html)
International Commission on Nonionizing Radiation Protection (http://www.icnirp.de)