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Senior Citizen Health & Medicine
FDA Finds Points of Disagreement with JAMA Report
Questioning Safety of Automated External Defibrillators
 August 14, 2006 – The Food and Drug Administration
has found areas of disagreement with an article in the current issue of
the Journal of the American Medical Association that found a need for a
more reliable system to locate and repair potentially defective
Automatic External Defibrillators (AEDs) in a timely fashion. A
statement from the FDA says the agency supports this kind of research
and most of the conclusions reached in the JAMA article are consistent
with FDA's own findings. However, there are a few points on which the
agency differs.
(See original report
on JAMA story in sidebar.)
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FDA's Frequency of Alerts on Defibrillators Demands Better System
Study in JAMA finds
device malfunctions relatively small but too frequent
August 8, 2006 - The Food and Drug Administration
frequently issues safety advisories for automated external
defibrillators (portable electronic device used to restore regular heart
beat in patients with cardiac arrest) and accessories, although the
number of actual device malfunctions appears to be relatively small,
according to a study in the August 9 issue of the Journal of the
American Medical Association. The authors see a need for a more reliable
system to locate and repair potentially defective devices in a timely
fashion.
Read more...
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Health & Medicine |
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First, says the FDA statement, "the authors assert
that manufacturers are unable to track AED units, making it impossible
to know how many AED units were actually fixed or taken out of service.
"However, under FDA regulations, manufacturers are
required to track AEDs and are doing so with processes in place to
identify the location of a device in the event of a recall. Our records
show that these devices are being tracked with a high level of
accuracy."
In fact, says the FDA, more than 95 percent of the
AEDs affected by Class I recalls in 2005 were returned to the
manufacturers or taken out of service. Fewer than three percent were
lost or stolen."
In the past decade, these devices have become
simpler to use and have been placed in more public places like airports
and schools.
The second point of disagreement was a statement in
the JAMA article saying there has been an increase in the number of AEDs
affected by advisories during the study period.
This is true, concedes the FDA, however, the FDA
believes that improvements in the devices' ability to self-diagnose
hardware and software problems may contribute to this trend.
"This capability may result in users reporting
problems before a device is ever used on a patient. Also, while more
than 21 percent of AEDs were affected by an advisory, it does not
necessarily mean that they malfunctioned. A device advisory is issued
when a medical device has the potential to exhibit a certain failure
mode, not only when a device has, in fact, failed." the FDA says.
In conclusion, the FDA said, "We continue to depend
on our ability to work with owners of AEDs when these devices are
subject to a recall and have taken steps in recent months to improve our
communication and collaboration with the broader community. AED users
should continue to report device malfunctions to the manufacturer and to
FDA. In addition, users should heed device error messages and warnings
during regular device self-checks and respond appropriately to recall
notices and safety alerts."
AEDs are important medical devices and numerous
studies have shown that thousands of lives are saved each year using
these devices to treat patients in sudden cardiac arrest, according to
the agency.
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