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Section 4: Safety Guidelines and Warranty Information
122 4A: Safety
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.
25. Which other federal agencies have responsibilities related to
potential RF health effects?
Certain agencies in the Federal Government have been involved in
monitoring, researching or regulating issues related to human exposure
to RF radiation. These agencies include the Food and Drug
Administration (FDA), the Environmental Protection Agency (EPA), the
Occupational Safety and Health Administration (OSHA), the National
Institute for Occupational Safety and Health (NIOSH), the National
Telecommunications and Information Administration (NTIA) and the
Department of Defense (DOD).
By authority of the Radiation Control for Health and Safety Act of 1968,
the Center for Devices and Radiological Health (CDRH) of the FDA
develops performance standards for the emission of radiation from
electronic products including X-ray equipment, other medical devices,
television sets, microwave ovens, laser products and sunlamps. The
CDRH established a product performance standard for microwave ovens
in 1971 limiting the amount of RF leakage from ovens. However, the
CDRH has not adopted performance standards for other RF-emitting
products. The FDA is, however, the lead federal health agency in
Sprint FM OUG NO BROWSER CTIA-3a.book Page 122 Wednesday, October 9, 2002 1:42 PM