FDAnews Device Daily Bulletin

FDA NOTIFICES MEDICAL TELEMETRY SYSTEM USERS OF POTENTIAL INTERFERENCE

Nov. 23, 2005
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Medical telemetry systems operating in the 460-470 MHz frequency bands will be at greater risk of interference after Dec. 31, according to an FDA public health notification. Starting in January, the Federal Communications Commission (FCC) will start issuing numerous licenses for mobile radio transmitters operating in the same band range, the agency said.

It is estimated that several hundred thousand users are waiting to be granted licenses in the 460-470 MHz band, including police and fire and rescue departments, and taxi and commercial truck operators, the FDA said recently.

Interference from such mobile radios could adversely affect wireless medical telemetry equipment, which is used in hospitals and healthcare facilities to transmit patient measurement data to a nearby receiver. Medical telemetry equipment includes heart and blood pressure and respiration monitors. Interference can lead to lapses in patient monitoring and missed alarm events, the FDA said.

The anticipated interference would not be limited to urban areas, the FDA noted: "Any medical facility in the vicinity of a mobile radio could be affected."

The agency recommends users of medical telemetry products determine if their systems are operating in the 460-470 MHz range and, if so, migrate out by Dec. 31. The FDA also urged users to communicate with local broadcasters, so they can be informed of changes in use of the spectrum, and to register their medical telemetry equipment with the American Society for Healthcare Engineering of the American Hospital Association, the frequency coordinator for WMTS.

For more information, go to http://www.fda.gov/cdrh/safety/111605-wmts.pdf (http://www.fda.gov/cdrh/safety/111605-wmts.pdf).