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FDA Proposes Tighter Regulation of Public Defibrillators
Date:3/23/2013

By Steven Reinberg
HealthDay Reporter

FRIDAY, March 22 (HealthDay News) -- To improve the quality of lifesaving devices called automated external defibrillators, the U.S. Food and Drug Administration proposed Friday that the seven manufacturers of these devices be required to get agency approval for their products.

Automated external defibrillators (AEDs) are portable devices that deliver an electrical shock to the heart to try to restore normal heart rhythms during cardiac arrest. Although the FDA is not recalling AEDs, the agency said that it is concerned with the number of recalls and quality problems associated with them.

"[The] FDA is not questioning the clinical utility of AEDs," Dr. William Maisel, chief scientist in FDA's Center for Devices and Radiological Health, said during a press conference on Friday announcing the proposal.

"These devices are critically important and serve a very important public health need. The importance of early defibrillation for patients who are suffering from cardiac arrest is well-established," he said.

Maisel added the FDA is not calling into question the safety or quality of AEDs currently in place around the country.

There are about 2.4 million such devices in public places throughout the United States, according to The New York Times.

"Today's action does not require the removal or replacement of AEDs that are in distribution. Patients and the public should have confidence in these devices, and we encourage people to use them under the appropriate circumstances," Maisel said.

Although there have been problems with AEDs, their lifesaving benefits outweigh the risk of making them unavailable, Maisel explained.

Dr. Moshe Gunsburg, director of cardiac arrhythmia service and co-chief of the division of cardiology at Brookdale University Hospital and Medical Center in Brooklyn, N.Y., supports the FDA proposal.

"Cardiac arrest is
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