(Reuters) - The U.S. Food and Drug Administration is proposing new rules aimed at improving the reliability of emergency defibrillators 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.
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.
Physio-Control’s chief executive, Brian Webster, said the increase in device failures can partly be attributed to the fact that they are more prevalent.
“While it is the FDA’s position that defibrillator failures have risen over the past several years, the number of devices in the market has grown dramatically over that same time period,” he said. “An evaluation of the number of defibrillator malfunctions must include the number of devices deployed to accurately assess whether the failure rate is increasing or actually decreasing.”
Maisel said it was not possible to give a precise number of times emergency defibrillators were used and therefore what the failure rate is, but he said “our perception is that the failure rate is quite small.”
Officials at Zoll were not immediately reachable for comment.
Maisel said the cost of the marketing application for each company would be $248,000 but that one application would cover all its models. And he said he does not expect most companies which have products on the market to have to conduct additional clinical studies. Most, he said, would already have collected the data.
Reporting by Toni Clarke in Washington and Debra Sherman in Chicago; Editing by Gerald E. McCormick, Matthew Lewis and Richard Chang