FDA Tightens Rules for Approval of Emergency Defibrillators

The U.S. Food and Drug Administration said on Wednesday it is tightening the requirements for approval of emergency defibrillators following thousands of reports of malfunctioning devices.

The defibrillators, also known as AEDs, are found in hundreds of airports, shopping malls and restaurants across the country and are designed to jump-start the heart and restore normal rhythm in an emergency.

From January 2005 through September 2014, the FDA said it received roughly 72,000 reports of the devices failing. Since 2005 manufacturers have issued 111 recalls affecting more than 2 million devices.

Under the new rules, companies will need to provide clinical data or other evidence proving the devices are safe and effective in order to be approved or remain on the market. The agency will also inspect their manufacturing facilities prior to approval.

The FDA said it will allow AEDs currently on the market to remain available until companies meet the new requirements, which will not be enforced until July 29, 2016.

"These changes to the way these devices are reviewed will allow us to more closely monitor how they are designed and manufactured," said Dr. William Maisel, deputy director for science in the FDA's center for devices and radiological health. "This will go a long way towards correcting long-standing problems and ultimately improving the reliability of these devices."

Companies who make AEDs include Zoll Medical Corp, Physio-Control Inc and Royal Philips Electronics.

Most problems involved the design or manufacture of the device, or inadequate control of components purchased from other suppliers, the FDA said.

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