FDA to toughen review of defibrillators
WASHINGTON — Those automatic defibrillators that dot every office building, airport and shopping mall around the country? They undoubtedly have saved people who otherwise might have dropped dead from a heart attack. But too often, they fail miserably at the very moment they are most needed.
The devices malfunction so frequently, in fact, that from 2005 to 2014 the Food and Drug Administration has received about 72,000 reports of the defibrillators failing in one way or another, from not properly powering up to not delivering the electrical jolt necessary to restore a normal heart rhythm to someone suffering cardiac arrest.
In an effort to strengthen the quality and reliability of automated external defibrillators, or AEDs, the FDA recently said it would begin requiring manufacturers to submit the devices to a more rigorous review before they hit the market.
“We know that AEDs save lives, and they can be highly effective” when used during emergencies, said William Maisel, chief scientist at the FDA's Center for Devices and Radiological Health. “But these devices also have a history of malfunction.”
The announcement comes years after the FDA began expressing concern about the regularity of the problems associated with AEDs.
In 2010, the agency released a report detailing those failures, some of which likely cost lives. For instance, a faulty design led to a momentary drop in voltage in one device, which caused it to shut down before it could deliver a shock to a patient in need.
The agency concluded that improved design and manufacturing practices could help prevent many such problems. One company, for example, had fixed a defect in one of its devices on a case-by-case basis, but had never sought to systematically check and fix the issue in all the units it had sold. Other companies had relied on suppliers for various components, such as batteries and electrodes, that didn't meet certain standards.
Under the new FDA order, manufacturers will have to submit details of their designs and quality-control procedures before the FDA approves the devices for sale. In addition, the FDA also plans to conduct inspections of manufacturing facilities before approval.
The agency said it will not begin enforcing the new restrictions until July 29, 2016, and that AEDs currently on the market will remain available in the interim, as long as their manufacturer says it intends to meet the new requirements. The FDA won't apply the new rules to certain AED accessories until early 2020.
Historically, for devices subject to premarket approval, manufacturers would have to undertake drawn out and potentially costly clinical trials. But Maisel said that he doesn't expect the process to be “particularly onerous” for AEDs, because most manufacturers already have collected much of the data necessary.
He also insisted the FDA isn't questioning the usefulness of defibrillators in general but merely trying to make sure they fail less often.
“We're not fundamentally questioning the clinical utility of AEDs,” he said. “For the AEDs that work, they are extremely clinically useful and lifesaving devices.”
Once almost exclusively in emergency rooms, automated defibrillators have proliferated in recent decades. Simple-to-use versions have popped up in public places throughout the country, from casinos to churches. They are designed to automatically detect life-threatening cardiac arrhythmias and guide almost anyone through the process of delivering a shock that can restore the heart's normal rhythm.
Public health officials have long encouraged their use as a tool in combating some of the nearly 383,000 sudden cardiac arrests that occur each year in the United States. But some experts say the AEDs presence in public places, although helpful, does little to lower overall death rates from such events. Experts say that portable defibrillators are needed in people's homes, where 4 out of 5 cardiac arrests take place.