User Manual

168
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. 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.
13. What about wireless phone interference with medical equipment?
Radiofrequency 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 hearing aids for interference from handheld 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 conduct testing