User Guide

147

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 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.

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/Radiation-EmittingProducts/RadiationEmittingProductsandProcedures/

HomeBusinessandEntertainment/CellPhones/default.htm)

•

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)

•

Health Protection Agency (UK) (http://www.hpa.org.uk/radiation/)

AVOID POTENTIAL HEARING LOSS

Prolonged exposure to loud sounds (including music) is the most common cause of preventable

hearing loss. Some scientific research suggests that using portable audio devices, such as portable

music players and cellular telephones, at high volume settings for long durations may lead to