For Your Safety 187
11. What about wireless device interference with medical
equipment?
Radio Frequency (RF) energy from wireless devices can interact with some
electronic devices. For this reason, the FDA helped develop a detailed test
method to measure Electro Magnetic 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 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 device EMI.
The FDA has tested hearing aids for interference from handheld wireless
devices 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 devices so that no
interference occurs when a person uses a “compatible” device and a “compatible”
hearing aid at the same time. This standard was approved by the IEEE in 2000.
The FDA continues to monitor the use of wireless devices 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 devices
http://www.fda.gov/Radiation-EmittingProducts/
RadiationEmittingProductsandProcedures/HomeBusinessandEntertainment/
CellPhones/default.htm
Federal Communications Commission (FCC) RF Safety Program
http://www.fcc.gov/oet/rfsafety
International Commission on Non-lonizing 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.hpa.org.uk/radiation/
