FDA Tightens Rules on Defibrillators as Recalls Mount

External defibrillators, devices that shock hearts back into normal rhythms, will face tougher U.S. regulations under a proposal designed to cut down on the number of malfunctions.

The Food and Drug Administration plans to require manufacturers submit more rigorous studies of automated external defibrillators to receive approval. Recalls of the devices have shown current rules are unsuccessful, the agency said in a proposal published today in the Federal Register.

Automated external defibrillators, made by companies such as Royal Philips Electronics NV, are portable devices that can be used in an office, shopping mall or school and are carried by police and ambulance crews. External defibrillators were linked to 45,000 malfunctions and adverse events and 88 recalls from 2005 to 2012, William Maisel, chief scientist with the FDA’s Center for Devices and Radiological Health.

“We do have confidence in the AEDs in distribution,” Maisel said.

The devices help resuscitate people who experience sudden cardiac arrest, a condition when the heart stops beating that typically causes death within minutes. There are about 300,000 sudden cardiac deaths per year, Maisel said.

Most of the automated external defibrillators already have the clinical data needed to support a pre-market application, the FDA said. The devices had to prove only that they were similar to others on the market to receive FDA clearance.

No Shortages

Philips, based in Amsterdam, isn’t concerned today’s action, once made final, will result in an interruption in the distribution of the company’s devices, Steve Klink, a spokesman, said in an e-mail. Manufacturers will have plenty of time to prepare their submissions and the FDA doesn’t expect shortages, Maisel said.

The FDA said it plans to exercise enforcement discretion for 15 months after the proposal takes effect. The requirements will kick in by the end of 2014. Companies will have to pay $248,000 per application for FDA’s review, Maisel said.

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