43
Heal
th an
d saf
ety i
nfor
matio
n
According to FTC, these defendants lacked a reasonable basis to
substantiate their claim.
What about device interference with medical equipment?
Radio frequency energy (RF) from devices 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 device EMI. FDA has tested devices 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 devices so that no
interference occurs when a person uses a compatible device 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 devices 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.
• Additional information on the safety of RF exposures from various
sources can be obtained from the following organizations:
• FCC RF Safety Program: