FDA seeks to toughen defibrillator regulations

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WASHINGTON -- The Food and Drug Administration announced Friday that it was moving to toughen regulation of the industry that produces heart defibrillators -- devices that are used to jolt a failing heart back into its regular rhythm -- after tens of thousands of malfunctions and hundreds of deaths in recent years.

In one case, a nurse was trying to hook up a defibrillator to a patient in cardiac arrest when its electronic screen read "memory full" and then shut down, according to one example provided by the FDA. The patient soon died. In another case, a software defect caused the device to show an "equipment disabled" message. That patient also died.

The devices, which can be found in malls, airports, casinos and churches in addition to medical settings, re-establish cardiac rhythms in patients whose hearts have abruptly stopped or lost their regular beats. Such cardiac arrests kill as many as 400,000 people a year in the United States, according to the American Heart Association -- more deaths than caused by Alzheimer's disease, diabetes and accidents combined.

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, such as battery failure. Manufacturers have recalled the devices 88 times in that period.

The problems led the agency to propose a change that would allow it to more closely monitor how the devices -- known as automated external defibrillators, or AEDs -- are designed and made. There are about 2.4 million such devices in public places across the country.

William Maisel, chief scientist at the FDA's Center for Devices and Radiological Health, said in a statement that the agency was "concerned about the number of recalls and manufacturing problems that have been associated with these devices."

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

Such a change would typically require defibrillator makers to conduct costly and time-consuming clinical trials, but Dr. Maisel said many of the nine manufacturers in the country had already collected the data that such trials would produce, and that only a couple would need to carry out such studies.

A spokeswoman for Philips, one of the manufacturers, said the change would not interrupt distribution, but she added that the company needed to review the FDA order before commenting on whether future supplies would be affected. Another major manufacturer, Physio-Control, in Washington state, said in a statement that it was "extremely confident in our ability to meet these new regulations, if adopted."

Death rates from cardiac arrests have changed little since the 1980s, when defibrillators first became widely available to the public. Experts say those grim statistics could change if more of the devices were accessible to more people.



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