Posted by mnewman on 04/29/2013

Articles such as "The Loophole That Keeps Precarious Medical Devices in Use" and “AEDs in the Workplace, Benefit or Burden,”  which raise concerns about the safety of automated external defibrillators (AEDs) without recognizing their overarching life-saving value, create confusion and are not in the public’s best interest.

Consider this. If 2.4 million AEDs are deployed in public places in the U.S., and there have been 45,000 reports to the FDA of “device failure or malfunction” since 2005, this represents a “device failure or malfunction rate” of less than 2 percent.

The true rate is even lower, however, since many of the “device failure or malfunction” reports resulted from routine device self-checks and did not occur during actual use on sudden cardiac arrest (SCA) victims. Further, many reported device failures were actually human failures to properly maintain devices. All told, then, the true “device failure or malfunction” rate is exceedingly low.

Further, AEDs do not cause death. Rather, they are used to restore life for people who die suddenly. While they cannot help every victim of sudden death, they at least give many victims a fighting chance.

Granted, if AEDs are reclassified as “high-risk” devices requiring time-consuming, expensive regulatory hurdles, the already low “device failure or malfunction rate” could decrease even further, but at what cost?

Sudden cardiac arrest affects 1,000 people outside hospitals each day in the U.S. including youth (359,400 cases annually), and only 10% of victims survive. Survival rates increase to 38%, however, when bystanders provide CPR and use AEDs before EMS arrives. If the average survival rate increased from 10% to 38%, as many as 100,000 additional lives could be saved each year.

That, of course, would depend on widespread availability of properly maintained AEDs—and increased public awareness about the critical importance of immediate bystander action.

The public’s health would be better served if the media focus shifted from “what can go wrong” with AEDs to what goes right for SCA victims when they are treated quickly with these safe and effective lifesaving devices.

More coverage on the topic...

 

 

 

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