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Misc. News : C.onsumer A.ffair Last Updated: Nov 12th, 2006 - 20:38:00

Mechanical defects plague many external defibrillators
By Kathy Jones
Aug 9, 2006, 09:44

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9 Aug, ( - Mechanical glitches in automated external defibrillators have caused around 370 deaths, a new study finds. Automated external defibrillators are life-saving devices used to re-start the heart after a cardiac arrest.

Automated external defibrillators are now present in malls, airports, even some churches and offer assurance that sudden cardiac death can be prevented by jolting the heart with an electric shock.

However the new study found that the defects are many and that U.S. Food and Drug Administration advisories on potentially malfunctioning defibrillators do not reach the right avenues.

The new study, which appears in the Aug. 9 issue of the Journal of the American Medical Association, says that a better notification system has be in place to prevent problems with the defibrillators.

"These are lifesaving devices, important devices, so I can understand a low threshold for issuing a recall. But there needs to be a better notification system in place," said lead researcher Dr. William H. Maisel, director of the Pacemaker and Defibrillator Service at Beth Israel Deaconess Hospital in Boston.

External defibrillators are routine emergency equipment at many public places. The effectiveness of these devices in preventing sudden heart deaths has meant that sales have jumped from about 20,000 in 1996 to about 200,000 today.

But during the same time, the FDA has issued 52 advisories covering 385,922 defibrillators or accessories, the study found. These advisories were issued in the form of press releases or alerts by the concerned manufacturer or the FDA.

"That is not an adequate information system for the public to learn what is being done," Maisel said. "The press release might not even be picked up by the media. There needs to be a better registration system for the people who purchase the devices and a better notification system when recalls are issued."

The data concerning the recalls and advisories on defibrillators was first presented at the Heart Rhythm Society 2006 Scientific Sessions in Boston, MA.

At that time Maisel observed, "One in five recalls is a high number for any product, let alone a life-saving product. These advisories occur frequently, they affect a lot of AEDs, and the mechanisms in place to notify AED users are poor. . . . Potentially, there are a lot of recalled AEDs that have not been replaced or repaired."

Last year around 192 400 defibrillators were sold in the US. But Maisel and his co-author Dr Jignesh Shah point out that there is no technical information released on the performance of these devices. In order to get some solid data on the real situation, the researchers analyzed weekly safety alerts and recalls affecting AEDs and AED accessories. These alerts were typically released by the FDA.

In the period from January 1996 to December 2005, around 52 advisories were released by the FDA. Of the 37 AED advisories, the FDA categorized 10.8 percent as class I meaning there was "reasonable probability that use of the product will cause serious adverse health consequences."

The remaining 83.7% were categorized as class II, meaning they could "possibly causing temporary or reversible adverse health consequences." Electrical or software-related issues were most often the cause for the advisory with a secondary reason being attributed to failure to detect the arrhythmia, failure to shock, and battery-related issues.

The authors’ stress that while the number of defibrillators that malfunction is very less, the number of lives saved is huge. "Efforts should be directed at developing a reliable system to locate and repair potentially defective devices in a timely fashion," they conclude.

The study added that sudden cardiac death is the leading cause of death in the United States, accounting for 330,000 deaths each year. If a defibrillator were applied quickly, many lives could be saved.

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