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Published on Jan 21, 2011 by Edgar Snyder

Defibrillators Need Stricter Regulations, FDA Says

unsafe defibrillator

Defibrillators, medical devices designed to save lives, have been the subject of an increasing number of recalls, including 17 in 2009. As a result, the Food and Drug Administration (FDA) has recommended more rigorous testing for the devices in an effort to reduce their design and manufacturing flaws.

The FDA has suggested that the makers of external defibrillators submit more data and undergo manufacturing inspections before they launch a new product. Under current rules, defibrillator makers are only subjected to inspections if the FDA suspects a problem. Several companies have petitioned to retain this standard, but the FDA said manufacturers have failed to fix problems that have resulted in the recall of hundreds of thousands of devices.

More than 28,000 defibrillator-related problems have been reported to the FDA in the past five years.

"FDA wants stricter testing for defibrillators." Associated Press. January 21, 2011.
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