palmOne Vision Smart Device Treo 650 User Manual page 300

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 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.
288 Safety