Additional Battery Testing for Medical Devices Recommended By FDA

On July 30 and 31, the Food and Drug Administration conducted a Battery-Powered Medical Devices Workshop to create awareness and address challenges associated with use of battery-powered medical devices. At the workshop, the FDA addressed the increasing number of adverse events linked to batteries in medical devices. While the FDA is confident that medical devices currently being marketed will continue to function appropriately, according to the agency, there are opportunities to further improve their design, overall performance and safety.

Batteries play a significant role in the overall safety, performance, and reliability of many life-saving and life-sustaining medical devices. As more medical devices become computerized, compact, and mobile, the number of battery-powered medical devices will continue to increase. The battery is one of the most critical components that can potentially impact the safety and effectiveness of medical devices. Unexpected depletion or failure of the battery can cause the device to stop functioning properly, preventing the device from delivering life-sustaining or life-saving therapy.

Manufacturers are advised to put more effort into testing batteries destined for use in medical products. According to an FDA official, agency inspectors will be looking at production controls and acceptance activities related to batteries, as well as battery storage, during routine audits of manufacturing facilities. Inspectors will be looking for such quality issues as unexplained battery depletion, battery leakage and unexplained premature failure of implanted devices.

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