Heart-Shock Machines: High Recall Rate
Despite Flaws, Emergency Heart-Shock Devices Save Thousands of Lives
Aug. 8, 2006 -- You now see automated heart-shock machines in all kinds of public places. But one in five such devices are hit by product recalls, a U.S. study finds.
Over the past decade, flaws in the devices have resulted in at least 370 deaths.
However, that's far fewer than the number of lives they have saved.
The machines are called automated external defibrillators, or AEDs. They analyze the heart's electrical activity and can give a life-saving electric shock to the chest of a person who has collapsed from cardiac arrest.
Without the shock, nearly all such cardiac arrest victims die.
That's why AEDs are placed in so many airports, sports arenas, casinos, schools, and churches.
The devices are simple to use - even a sixth-grader could understand if told what to do.
And almost anyone can operate one; but you have to act fast. Every minute that passes cuts the victim's chance of survival by 10%.
Still, these easy-to-use devices are extremely complex machines. And complex things break down.
How often? Jingnesh S. Shah, MD, and William Maisel, MD, MPH, of Beth Israel Deaconess Medical Center, looked at the issue.
They found that between 1996 and 2005, AED manufacturers issued 52 advisories about possible flaws affecting 385,922 AEDs. That's more than one in five of the devices.
"An AED recall rate of 1 in 5 over the past decade is too high," Maisel says in a news release.
However, only 1 in 10 of the advisories was a warning that the device could cause serious harm to a patient.
Also, only a small number of AEDs included in an advisory actually contain a flaw.
"AEDs are responsible for saving thousands of lives," Maisel says. "Our study demonstrates that there is an urgent need to develop a more reliable system to identify and repair potentially defective AEDs in a timely fashion and to better notify AED owners when their devices are recalled."
The Maisel team reports its findings in the August 9 issue of JAMA, The Journal of the American Medical Association.