the United Kingdom distributed leaflets containing such a recommendation in
December 2000. They noted that no evidence exists that using a wireless
Device
causes brain tumors or other ill effects. Their recommendation to limit wireless
Device
use by children was strictly precautionary; it was not based on scientific
evidence that any health hazard exists.
Do hands-free kits for wireless
Devices
reduce risks from exposure to RF
emissions?
Since there are no known risks from exposure to RF emissions from wireless
Devices
, there is no reason to believe that hands-free kits reduce risks. Hands-free
kits can be used with wireless
Devices
for convenience and comfort. These systems
reduce the absorption of RF energy in the head because the
Device
, which is 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 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
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 interference be found to occur, FDA will
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