FDA Looking for Tougher Standards for External Defibrillators

Recalls, failure to fix problems spurred agency to ask for more oversight

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By Steven Reinberg
HealthDay Reporter

TUESDAY, Jan. 25 (HealthDay News) -- Following a series of recalls of external defibrillators, the U.S. Food and Drug Administration is asking an expert panel to vote Tuesday on whether these devices should be held to stricter standards.

Over the past five years, there have been 68 recalls of these devices, which are used to shock a patient in cardiac arrest in hopes of getting the heart to beat normally again. Defibrillators are found in a variety of public places, from hospitals to malls and arenas, and are considered by many to be the best way of countering a cardiac arrest.

In addition to the recalls, the FDA has also received 23,591 reports of malfunctions of these devices, "including some where the device failure occurred during a rescue attempt and may have contributed to patient harm or death," the agency noted.

When defibrillators were first brought before the FDA, they went through an accelerated approval program designed for low-risk devices that included products such as hospital beds and artificial hips.

This 510(k) system allows fast approval of devices that are similar to products already on the market. Defibrillator manufacturers, including Philips Healthcare, Cardiac Science Corp., Defibtech and others, have asked the FDA to keep their devices in this category.

However, the agency said it is asking the panel to recommend stricter standards because manufacturers didn't fix the problems that led to the recalls.

The FDA wants these manufacturers to be subject to regular inspections and to be required to submit additional clinical data before introducing a new version of a defibrillator. This is the standard for implantable defibrillators, heart valves and some other devices, the agency noted.

External defibrillators have pads that are placed on a patient's chest to determine whether the heart is beating with an abnormal rhythm. If the problem is ventricular tachycardia or ventricular fibrillation, abnormal rhythms that can be treated, the pads deliver an electric shock that resets the heart's pumping sequence.

Each year, some 300,000 Americans suffer a cardiac arrest, according to the FDA. It has been estimated that nearly 500 of these lives are saved as a result of bystanders using an external defibrillator.

However the panel votes Tuesday, the FDA is not bound to follow its recommendations. But the agency typically follows the advice of its advisory panels.

More information

For more on cardiac arrest, visit the U.S. National Library of Medicine.

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