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11. What about wireless phone interference with medical equipment?
Radiofrequency 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 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 accompanied 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.
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-Ionizing 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/
July 18, 2001 For updates: http://www.fda.gov/cdrh/phones
2600.ENv1_9233171.book Page 58 Tuesday, August 24, 2004 12:55 PM