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power to compensate, leading to an increase in RF
absorption. In February 2002, the Federal trade
Commission (FTC) charged two companies that sold
devices that claimed to protect wireless phone users
from radiation with making false and unsubstantiated
claims. According to FTC, these defendants lacked a
reasonable basis to substantiate their claim.
What about wireless phone interference with
medical equipment?
Radio frequency 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 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.
Additional information on the safety of RF exposures
from various sources can be obtained from the
following organizations:
• FCC RF Safety Program:
http://www.fcc.gov/oet/rfsafety/
• Environmental Protection Agency (EPA):
http://www.epa.gov/radiation/
Summary of Contents for SCH-W399
Page 2: ...SCH W399 User s Manual ...