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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 man-
ufacturers 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 vol-
untary 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.
10.What about children using wireless phones?
The scientific evidence does not show a danger to
users of wireless phones, including children and
teenagers. If you want to take steps to lower expo-
sure to radiofrequency energy (RF), the measures
described above would apply to children and
teenagers using wireless phones.Reducing the time
of wireless phone use and increasing the distance
between the user and the RF source will reduce RF
exposure.
Some groups sponsored by other national govern-
ments have advised that children be discouraged
from using wireless phones at all. For example, the
government in the United Kingdom distributed
leaflets containing such a recommendation in
December 2000.They noted that no evidence exists
that using a wireless phone causes brain tumors or
other ill effects. Their recommendation to limit wire-
less phone use by children was strictly precaution-
ary; it was not based on scientific evidence that any
health hazard exists.
11.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
Chapter 10
Safety Guidelines