the United Kingdom distributed leaflets containing such a recommendation in
December 2000. They noted that no evidence exists that using a wireless phone
causes brain tumors or other ill effects. Their recommendation to limit wireless phone
use by children was strictly precautionary; it was not based on scientific evidence
that any health hazard exists.
D o h a n d s -fr e e k i ts fo r w i r e l e s s p h o n e s r e d u c e r i s k s fr o m e x p o s u r e to R F
e m i s s i o n s ?
Since there are no known risks from exposure to RF emissions from wireless phones,
there is no reason to believe that hands-free kits reduce risks. Hands-free kits can be
used with wireless phones for convenience and comfort. These systems reduce the
absorption of RF energy in the head because the phone, which is the source of the
RF emissions, will not be placed against the head. On the other hand, if the phone 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 phones 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.
D o w i r e l e s s p h o n e a c c e s s o r i e s th a t c l a i m to s h i e l d th e h e a d fr o m R F r a d i a ti o n
w o r k ?
Since there are no known risks from exposure to RF emissions from wireless phones,
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 phone cases, while others involve nothing more than a
metallic accessory attached to the phone. 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 phone. The phone 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 phone users from radiation with making false and
unsubstantiated claims. According to FTC, these defendants lacked a reasonable
basis to substantiate their claim.
W h a t a b o u t w i r e l e s s p h o n e i n te r fe r e n c e w i th m e d i c a l e q u i p m e n t?
Radio frequency 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
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 phone EMI. FDA has tested 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 possible interactions with
other medical devices. Should harmful interference be found to occur, FDA will
DRAFT, Not Final
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