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184 Appendix
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
“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.
12. Where can I find additional information?
For additional information, please refer to the following resources:
• For FDA web page on wireless phones, visit
http://www.fda.gov/Radiation-EmittingProducts/
RadiationEmittingProductsandProcedures/
HomeBusinessandEntertainment/CellPhones/default.htm.
• For Federal Communications Commission (FCC) RF Safety Program, visit
http://www.fcc.gov/oet/rfsafety.
• For International Commission on Non-Ionizing Radiation Protection,
visit http://www.icnirp.de.
• For World Health Organization (WHO) International EMF Project,
visit http://www.who.int/peh-emf.
For National Radiological Protection Board (UK), visit
http://www.hpa.org.uk/radiation.