Magazine article FDA Consumer

EMI and Medical Devices

Magazine article FDA Consumer

EMI and Medical Devices

Article excerpt

FDA is taking steps to make sure that electromagnetic interference (EMI) from such appliances as cellular phones, radio and TV transmitters, and emergency mobile communications equipment does not cause some electronic medical devices to malfunction.

After receiving reports of such occurrences, the agency increased its monitoring of possible EMI-related problems and began working with manufacturers and voluntary standards organizations to make medical devices more immune to EMI. This work has resulted in devices with improved electromagnetic compatibility (EMC), meaning that the device will not emit signals into the environment that would cause EMI in other devices, and that the device will function properly in its electromagnetic (e.g., radio wave) environment.

Devices on which action has been taken include:

* Respiratory devices--FDA now requires new respiratory devices, such as ventilators, to meet an FDA guideline for EMI before they can be approved for marketing. The agency plans to develop similar guidelines for other medical devices as needed.

* Power-driven wheelchairs and scooters--FDA tested them, inspected manufacturers, and asked manufacturers and consumer groups representing users to provide information. The agency found that radio waves can cause unexpected movement in some power-driven wheelchairs and scooters and is requiring all firms to clearly label wheelchairs and scooters with the immunity level, or state that the immunity level is not known, and to place warning labels on wheelchairs and scooters. FDA asked manufacturers to establish a minimum recommended immunity level to EMI of 20 volts per meter for all new motorized wheelchairs and scooters. …

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