FDA Workshop Shines Spotlight On Device Battery Hazards And Potential Solutions

Article preview from "The Gray Sheet" - August 05, 2013

 An increasing number of adverse events linked to device batteries points to the need for better design and performance guidelines, according to participants at a July 30-31 FDA meeting.

FDA Workshop Shines Spotlight On Device Battery Hazards And Potential Solutions

Article preview from "The Gray Sheet" - August 05, 2013

In the wake of an increasing number of adverse events linked to device battery use or quality, speakers at a July 30-31 FDA workshop on battery-powered medical devices said requirements or guidelines to ensure better battery performance, quality and user understanding are badly needed.

“There would be value in developing high-level requirements that provide guidance relative to performance, while allowing flexibility on how to demonstrate compliance to those requirements,” said Dominick Frustaci, vice president of R&D at battery manufacturer Greatbatch Medical Inc.

CDRH held the workshop with two major goals: to create awareness of current and future challenges related to battery-powered medical devices, and to brainstorm potential solutions.

As more medical devices become computerized, compact and mobile, the number of battery-powered devices will continue to increase, FDA said in the workshop program. “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,” the agency said.

In workshop presentations, CDRH staffers and others elaborated on additional battery challenges. More than 700 people either attended the workshop in person in Silver Spring, Md., or listened and participated online, according to CDRH Chief Scientist William Maisel and CDRH battery working group co-leader Ken Skodacek.

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