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Health and Safety Information 100
the source of the RF emissions, will not be placed against the
head. On the other hand, if the device is mounted against the
waist or other part of the body during use, then that part of the
body will absorb more RF energy.
Wireless devices marketed in the U.S. are required to meet safety
requirements regardless of whether they are used against the
head or against the body. Either configuration should result in
compliance with the safety limit.
Do wireless device accessories that claim to shield
the head from RF radiation work?
Since there are no known risks from exposure to RF emissions
from wireless devices, there is no reason to believe that
accessories that claim to shield the head from those emissions
reduce risks. Some products that claim to shield the user from RF
absorption use special device cases, while others involve nothing
more than a metallic accessory attached to the device. Studies
have shown that these products generally do not work as
advertised. Unlike "hand-free" kits, these so-called "shields"
may interfere with proper operation of the device. The device
may be forced to boost its power to compensate, leading to an
increase in RF absorption. In February 2002, the Federal trade
Commission (FTC) charged two companies that sold devices that
claimed to protect wireless device users from radiation with
making false and unsubstantiated claims.
According to FTC, these defendants lacked a reasonable basis to
substantiate their claim.
What about wireless device interference with
medical equipment?
Radio frequency energy (RF) from wireless 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 devices. 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 device EMI. FDA has tested wireless 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
wireless 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 wireless devices for possible
interactions with other medical devices. Should harmful
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