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from wireless phones can interact with some electronic devices. For this reason, the FDA helped develop a detailed test method to measure Electro Magnetic 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 the 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.

The 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.

The FDA continues to monitor the use of wireless phones for possible interactions with other medical devices. Should harmful interference be found to occur, the FDA will conduct testing to assess the interference and work to resolve the problem.

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