Health and Safety Information
175
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 to assess the interference
and work to resolve the problem.
10.What are the results of the research done already?
The research done thus far has produced conflicting results, and
many studies have suffered from flaws in their research methods.
Animal experiments investigating the effects of radio frequency
energy (RF) exposures characteristic of wireless phones have yielded
conflicting results that often cannot be repeated in other laboratories.
A few animal studies, however, have suggested that low levels of RF
could accelerate the development of cancer in laboratory animals.
However, many of the studies that showed increased tumor
development used animals that had been genetically engineered or
treated with cancer causing chemicals so as to be pre-disposed to
develop cancer in the absence of RF exposure. Other studies exposed
the animals to RF for up to 22 hours per day. These conditions are
not similar to the conditions under which people use wireless