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Section 4A: Safety Guidelines 189
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
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 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 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