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Emergency defibrillators should be reinspected, says FDA

26 Mar 2013, 16:05
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Emergency defibrillators

According to the Reuters report, FDA is proposing new rules following some 45,000 reports of device failures over the past seven years.

 

The defibrillators, found in hundreds of airports, shopping malls and restaurants across the country, are designed to jump-start the heart after it has suddenly stopped.

 

The FDA said its proposal would require manufacturers to provide clinical data or other evidence proving their devices are safe and effective in order to be approved or remain on the market.

 

The proposals would also require manufacturers to provide inspection reports and submit to the FDA details of any changes made to the device. Companies will have 15 months to submit the information to the FDA once the proposals are final.

 

Dr. William Maisel, deputy director of the FDA's center for devices and radiological health, said there were 88 recalls of automated emergency defibrillators in the seven years from 2005 to 2012 as well as thousands of malfunctions.

 

He said it was not possible to estimate how many deaths occurred due to the malfunctions since death may have occurred anyway, but there have been enough cases of device malfunctions to warrant concern.

 

Most problems involved the design or manufacture of the device, or inadequate control of components purchased from other suppliers, Maisel said, adding that the agency would focus on these areas when reviewing the new marketing applications.

 

Makers of emergency defibrillators include Physio-Control Inc, Zoll Medical Corp and Royal Philips Electronics NV.

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