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FDA to Strengthen Approval Process for AEDs

Agency has received 72,000 reports of automated external defibrillators failing

WEDNESDAY, Jan. 28, 2015 (HealthDay News) — Automated external defibrillators installed and ready for use in many public spaces can save lives when needed, but the U.S. Food and Drug Administration says that since 2005, it has also received 72,000 reports of the devices failing.

The agency said that, based on these incidents, it will strengthen its approval process for external defibrillators and their accessories, including batteries, pad electrodes, adapters, and other items. The devices do “save lives,” William Maisel, M.D., M.P.H, deputy director for science, chief scientist, and acting director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health, said in an agency news release. However, the new changes “will allow us to more closely monitor how they are designed and manufactured,” he said. “This will go a long way towards correcting long-standing problems and ultimately improving the reliability of these devices.”

The FDA said it will also carry out inspections of manufacturers’ facilities prior to approving the defibrillators. After approval, manufacturers will have to file annual reports on each device’s performance and inform the agency about any changes made to the defibrillators that affect safety and effectiveness.

The FDA said that devices currently on the market will remain available while manufacturers work to meet the new requirements for the devices, which take effect in mid-2016. New requirements for current, necessary accessories will take effect January 2020.

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