FDA Panel Recommends Tougher Standards for External
TUESDAY, Jan. 25 (HealthDay News) -- Following a series of
recalls of external defibrillators, a U.S. Food and Drug
Administration panel of experts recommended Tuesday that the
devices be held to stricter standards.
Over the past five years, there have been 68 recalls of
automated external defibrillators, which are used to shock a
patient in cardiac arrest in hopes of getting the heart to beat
normally again, and are considered by many to be the quickest and
best response to such an emergency.
In addition to the recalls, the FDA has also received 23,591
reports of device malfunctions, "including some where the device
failure occurred during a rescue attempt and may have contributed
to patient harm or death," the agency noted in an executive summary
released before the meeting of its Circulatory System Devices
No official vote was taken by the panel, according to
The New York Times, but most panel members said they felt the defibrillators should be placed in a high-risk category.
Dr. John W. Hirshfeld Jr., chairman of the advisory panel and a
professor of cardiovascular medicine at the University of
Pennsylvania, noted that "there are a number of signals that raise
questions about quality and reliability," the
When external defibrillators were first brought before the FDA,
they went through an accelerated approval program designed for
low-risk devices that included such products as hospital beds and
artificial hips. This so-called 510(k) system allows fast approval
of devices that are similar to products already sold. Defibrillator
manufacturers -- including Cardiac Science Corp., Defibtech,
Philips Medical Systems, Zoll Medical Corp., and others -- have
asked the FDA to keep their devices in this category, the
Associated Press reported.
However, the agency said it was asking the advisory panel to
recommend stricter standards because manufacturers did not fix the
problems that led to the recalls, the
The FDA wants the manufacturers to undergo regular inspections
and provide additional clinical data for any new version of an
external defibrillator, a procedure already in place for
implantable defibrillators, the
The manufacturers would have a year to 18 months to do so,
according to Dr. Bram D. Zuckerman, director of the division of
cardiovascular devices in the FDA's Office of Device Evaluation,
External defibrillators are computerized medical devices that
can check a person's heart rhythm and recognize a rhythm that
requires a shock. They can also tell a rescuer when a shock is
needed by using voice prompts, lights and text messages, according
to the American Heart Association.
Each year, approximately 300,000 Americans suffer a cardiac
arrest, according to the FDA. External defibrillators used by
bystanders seem to save an estimated 474 lives a year, according to
the FDA executive summary, and the devices are associated with
almost doubling the survival of out-of-hospital cardiac arrest
While the FDA is not bound to follow the recommendations of its
advisory panels, it typically does so.
For more on cardiac arrest, visit the
U.S. National Library of Medicine.
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