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UPDATE 1-FDA proposes tightening rules for heart defibrillators
March 22, 2013 / 2:45 PM / 5 years ago

UPDATE 1-FDA proposes tightening rules for heart defibrillators

March 22 (Reuters) - The U.S. Food and Drug Administration is proposing new rules aimed at improving the reliability of emergency defibrillators after receiving roughly 45,000 reports of device failures over the past seven years.

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.

Emergency defibrillators are used by paramedics and others to deliver electrical shocks to people in sudden cardiac arrest.

The proposals would also require manufacturers to provide inspection reports and submit to the FDA details of any changes made to the device.

Most problems reported with the devices are “preventable and correctable,” the FDA said in a statement. “The most common issues involve the design and manufacture of the devices and inadequate control of components purchased from other suppliers.”

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

Rachel Bloom-Baglin of Philips said the company has not yet seen the written version of the proposal. However, based on previous discussions with the FDA, the company believes that more scrutiny would not result in an interruption of supply of the defibrillators or accessories.

She said she believes there have been more reports of device failures in part because there are more of them in public places and many more people using them.

Officials at Physio-Control and Zoll were not immediately reachable for comment.

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