90
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 defib-
rillators 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 pos-
sible 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.
12. Where can I find additional information?
For additional information, please refer to the following
resources:
Safety
Safety
RD2230