User's Manual

safety and usage information
19
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.