User's Manual

Medical instrumentation (AAMI).
The nal draft, a joint effort by
FDA, medical device manufactur-
ers, and many other groups, was
completed in late 2000. This stan-
dard will allow manufacturers to
ensure that cardiac pacemakers and
debrillators 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 species 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 in-
teractions with other medical devic-
es. Should harmful interference be
found to occur, FDA will conduct
testing to assess the interference
and work to resolve the problem.
12) Where can I nd additional infor-
mation?
For additional information, please
refer to the following resources: