FDA Seeks to Toughen Defibrillator Regulations

The Food and Drug Administration will try to increase regulations governing the production of defibrillators, the medical devices that jumpstart heart that have stopped beating.

The machines are often used to save lives, but malfunctions have resulted in many deaths and injuries.

"There have been 45,000 reports of the devices failing or malfunctioning since 2005, agency officials said. The vast majority of them were due to manufacturing problems, officials said, but some were because of improper maintenance, like battery failure. Manufacturers have recalled the devices 88 times in that period," the New York Times writes.

"On Friday, the agency issued an order that, if made official after a public comment period, would require manufacturers to submit details of their designs and the controls they use in buying defibrillator components, many of which are produced abroad. Regulators would also be able to inspect manufacturers' factories."

Defibrillator manufacturers expressed concern that the new regulations could be too costly, preventing innovation in the design of new models, but they did not say whether they will oppose the new proposed rules, as they have not yet been released.

"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," writes NBC News.

Death rates from heart problems have remained constant since defibrillators became common in public places like restaurants and retail stores. But data shows the machines are used in only about 5 percent of situations in which they might have been helpful. Most heart problems occur in homes or private locations where there are no defibrillators. And most people are uncomfortable with their use or have not been trained to administer care.

In addition, many of the people who do receive care with a defibrillator may have been beyond saving in the first place.

The public will have 90 days to comment of the rules. In the rules are implemented, companies will have 90 days after that to file paperwork, and an additional 15 months to reconfigure or redesign the devices to meet the new standards.