Health and Safety Information
83
82
Health and Safety Information
H
E
A
LT
H
A
N
D
SA
FE
T
Y
IN
FO
R
M
A
T
IO
N
H
E
A
LT
H
A
N
D
SA
FE
T
Y
IN
FO
R
M
A
T
IO
N
What about wireless phone interference
with medical equipment?
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.
is test method is now part of a standard sponsored by
the Association for the Advancement of Medical
instrumentation (AAMI). e final draft, a joint effort
by FDA, medical device manufacturers, and many other
groups, was completed in late 2000. is 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). is 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. is standard
was approved by the IEEE in 2000.
e 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.
Additional information on the safety of RF exposures
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.
Do wireless phone accessories that claim to
shield the head from RF radiation work?
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 “hands-free” kits, these so-called
“shields” may interfere with proper operation of the
phone. e 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
the FTC, these defendants lacked a reasonable basis to
substantiate their claim.
800201_HTG_031308.qxp:user guide 3/13/08 1:06 PM Page 82
