News Headlines Article

F.D.A. Seeks to Toughen Defibrillator Regulations
New York Times

The Food and Drug Administration announced Friday that it was moving to toughen regulation of the industry that produces heart defibrillators — devices that are used to jolt a failing heart back into its regular rhythm — after tens of thousands of malfunctions and hundreds of deaths in recent years.

In one case, a nurse was trying to hook up a defibrillator to a patient in cardiac arrest when its electronic screen read “memory full” and then shut down, according to one example provided by the F.D.A.