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Section 12: Maintenance, Safety, and
Troubleshooting
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.
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 at the same
time. 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.
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 monitoring the latest research developments and
advising other agencies with respect to the safety of RF-emitting
products used by the public, such as cellular and PCS phones.
The FDA's microwave oven standard is an emission standard (as opposed
to an exposure standard) that allows specific levels of microwave
leakage (measured at five centimeters from the oven surface). The