User guide

11. What about wireless device interference

with medical equipment?

Radiofrequency 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 devices. 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 hearing aids for interference from

handheld 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