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Section 4A: Safety 158
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 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.
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 notadopted 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 standard also requires ovens to have
two independent interlock systems that prevent the oven from generating
microwaves the moment that the latch is released or the door of the oven is opened.
The FDA has stated that ovens that meet its standards and are used according to the
manufacturer’s recommendations are safe for consumer and industrial use. More
information is available from: w
ww.fda.gov/cdrh.