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Senior Citizen Alert
Good News: Lots of Public Defibrillators, Bad News:
Many Don't Work
New
data finds recalls of automated external defibrillators to be common
 May 18, 2006 – The good news for senior citizens is
that the distribution of life-saving automatic external defibrillators (AEDs)
has spread dramatically in public places, with 200,000 in place last
year. The terrible news is that about one in five don't work. Data
presented today at the Heart Rhythm Society's 27th Annual Scientific
Sessions finds that during a 10-year study period more than one in five
automatic external defibrillators (AEDs) were recalled due to potential
malfunction.
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The findings represent some of the first data
available on safety and reliability of the devices, which are used to
resuscitate victims of cardiac arrest.
"AEDs provide automated heart rhythm analysis,
voice commands, and shock delivery and can be used by individuals with
minimal training or experience," explains the study's lead author
William H. Maisel, MD, MPH, director of the Pacemaker and Device Service
at Beth Israel Deaconess Medical Center (BIDMC) and Assistant Professor
of Medicine at Harvard Medical School. "As a result, widespread
installation of AEDs has occurred in recent years." In fact, he adds,
the annual number of the devices distributed between 1996 and 2005
increased almost 10-fold, from fewer than 20,000 to nearly 200,000.
"Public places such as airports, sports arenas and
casinos are now routinely outfitted with AEDs and the U.S. Food and Drug
Administration [FDA] has approved certain AED models for home use," he
says. "Unfortunately, as AED use has increased, so too has the number of
recalled devices."
Maisel and his colleagues reviewed weekly FDA
Enforcement reports to identify recalls and safety alerts (collectively
referred to as "advisories") affecting AEDs. Enforcement reports are
issued by the FDA to notify the public about potentially defective
medical devices which may not function as intended.
During the study period – beginning in 1996 and
ending in 2005 – the authors found that the FDA issued 52 advisories
involving either AEDs or critical AED accessories, affecting a total of
385,922 devices.
"The results showed that during this 10-year study
period, more than one in five AEDs were recalled due to a potential
malfunction," says Maisel, noting that electrical and software problems
were the most common reasons for the advisories being issued. In
addition, he adds, the number of devices that were recalled increased
significantly over time.
In a separate analysis of publicly available FDA
data, the authors found that during the same 10-year period, 370
confirmed AED malfunctions occurred during attempted resuscitation of
cardiac arrest victims.
"While AED malfunctions do occasionally occur, the
number is small in comparison to the number of lives saved by these
important devices," notes Maisel. "However, because the number of AEDs
in distribution continues to increase rapidly, efforts should be
directed at developing a reliable system to locate and repair
potentially defective devices in a timely fashion."
Maisel and coauthor Jignesh S. Shah, MD are members
of the Cardiovascular Division, Beth Israel Deaconess Medical Center,
Boston. William Maisel is an FDA consultant and chair of the FDA
Circulatory System Medical Device Advisory Panel. The opinions expressed
herein are the personal views of the authors and do not necessarily
represent the policies, practices, positions or opinions of the FDA.
About information source:
Beth Israel Deaconess Medical Center is a patient
care, teaching and research affiliate of Harvard Medical School and
ranks fourth in National Institutes of Health funding among independent
hospitals nationwide. BIDMC is clinically affiliated with the Joslin
Diabetes Center and is a research partner of the Dana-Farber/Harvard
Cancer Center. BIDMC is the official hospital of the Boston Red Sox. For
more information, visit
www.bidmc.harvard.edu.
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