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11. What about wireless phone
interference with medical
equipment?
Radiofrequency energy (RF)
from wireless phones can
interact with some electronic
devices. For this reason, the
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
the 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. The 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.
The FDA continues to monitor
the use of wireless phones
for possible interactions
with other medical devices.
Should harmful interference
be found to occur, the FDA
will conduct testing to assess
the interference and work to
resolve the problem.
Safety Guidelines