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

the leading cause of death in the United States. It claims over 250,000 lives a year," he said.

Early defibrillation is the key to helping patients survive, Gunsburg said. Timing, however, is critical. If a patient is not defibrillated within four to six minutes, brain damage starts and the odds of survival diminish with each passing minute, which is why 90 percent of these patients don't survive, he explained.

The best chance a patient has is an automated external defibrillator used quickly, which is why Gunsburg and others want AEDs to be as common as fire extinguishers so laypeople can use them when they see someone go into cardiac arrest. The FDA's action will help ensure that these devices are in top shape when they are needed, he said.

But, there have been problems and failures with AEDs. Between 2005 and 2012 the FDA received about 45,000 reports of failure of these devices. In addition, there have been 88 recalls, Maisel said.

According to Maisel, it isn't known whether failures of AEDs cause any deaths. That's because when these devices are used, patients are in cardiac arrest and most die even when an AED is used and works well, he said.

However, machine defects may have contributed to patient deaths, the Times reported. For example, in one case, a nurse was attempting to attach a patient in cardiac arrest to a defibrillator when the device's screen read "memory full." In another case, a problem with a defibrillator's software caused the device to read "equipment disabled" as it was being used on a patient. In both cases, the patient died, the newspaper said.

The actual number of AED failures is also not known, but, "it's quite small," Maisel said. The most common problems are random power shutdowns, erroneous error messages and failure of the components of the machine, he noted.

"Tens of thousands of adverse events is too many. We think 88 recalls are too many," Maisel said.

"So, by calling for pre-
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