the source of the RF emissions, will not be placed against the head. On the other hand, if the device is mounted against the waist or other part of the body during use, then that part of the body will absorb more RF energy.

Wireless devices marketed in the U.S. are required to meet safety requirements regardless of whether they are used against the head or against the body. Either configuration should result in compliance with the safety limit.

Do wireless device accessories that claim to shield the head from RF radiation work?

Since there are no known risks from exposure to RF emissions from wireless devices, there is no reason to believe that accessories that claim to shield the head from those emissions reduce risks. Some products that claim to shield the user from RF absorption use special device cases, while others involve nothing more than a metallic accessory attached to the device. Studies have shown that these products generally do not work as advertised. Unlike "hand-free" kits, these so-called "shields" may interfere with proper operation of the device. The device may be forced to boost its power to compensate, leading to an increase in RF absorption. In February 2002, the Federal trade Commission (FTC) charged two companies that sold devices that claimed to protect wireless device users from radiation with making false and unsubstantiated claims.

According to FTC, these defendants lacked a reasonable basis to substantiate their claim.

What about wireless device interference with medical equipment?

Radio frequency 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 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 at the same time. This standard was approved by the IEEE in 2000.

FDA continues to monitor the use of wireless devices for possible interactions with other medical devices. Should harmful

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