User Guide

Table Of Contents

Additional safety information

11. 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 accompanied 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.

12. Where can I find additional information?

For additional information, please refer to the following resources:

• FDA web page on wireless phones

http://www.fda.gov/cdrh/phones/index.html

• Federal Communications Commission (FCC) RF Safety Program

http://www.fcc.gov/oet/rfsafety

• International Commission on Non-Ionizing Radiation Protection

http://www.icnirp.de

• World Health Organization (WHO) International EMF Project

http://www.who.int/emf

• National Radiological Protection Board (UK)

http://www.nrpb.org.uk/

July 18, 2001For updates: http://www.fda.gov/cdrh/phones