FDA Scrutinizes AEDs

Automated external defibrillators (AEDs) are a common sight in office buildings, shopping malls and most other large public spaces. Traditionally, they have not faced a lot of hurdles from the U.S. Food and Drug Administration (FDA). However, after receiving approximately 45,000 adverse event reports between 2005 and 2012 associated with the devices’ failure, the FDA has decided to crack down. Until now, AEDs have only required a 510(k) clearance, which is obtained under substantial equivalence. But the agency now is moving toward a pre-market approval process for the devices.

AEDs are portable, electronic medical devices that shock hearts back into normal rhythm with electrical stimulation when they sense potentially life-threatening cardiac arrhythmias. In addition to the thousands of adverse events reported, the FDA also reported dozens of manufacturer recalls. The agency called the problems encountered in the devices “preventable and correctable,” the most common issues involving the design and manufacture of the devices and inadequate control of components purchased from other suppliers.

“Automated external defibrillators save lives,” said William Maisel, M.D., M.P.H., deputy director of science and chief scientist at the FDA’s Center for Devices and Radiological Health. “However, the agency is concerned about the number of recalls and manufacturing problems that have been associated with these devices and we’re committed to working with manufacturers to address these issues.”

According to Maisel, even for manufacturers that would not be required to conduct clinical trials, the cost of complying with the new regulations would rise to about $220,000 from about $5,000. He said that companies with multiple models would have to pay that money only once, and that the sum could also be applied to subsequent versions.

While the FDA is launching a classification period to review AEDs, allowing it to more closely monitor how the devices are designed and manufactured, the agency will not limit access to AEDs immediately, as their evaluated benefits outweigh their risks.

The recently enacted Food and Drug Administration Safety and Innovation Act calls for the FDA to publish a proposed and final order to reclassify or call for PMAs for “pre-amendment” devices. AEDs were given a Class III designation when they were determined to be substantially equivalent to similar Class III devices that were on the market prior to the 1976 Medical Device Amendments. Following a series of meetings in 2011 to discuss which regulatory pathways is more appropriate to provide reasonable assurances of safety and effectiveness AEDs, the FDA’s Circulatory System Devices Panel recommended that AEDs remain Class III medical devices and require PMAs.

PMA applications are required to contain clinical data to support a product’s approval. However, added Maisel, “If our proposed order is finalized, the FDA intends to focus its review of the pre-market applications on the more problematic aspects of AEDs.”

In addition to the clinical safety and effectiveness data, a PMA must also include a review of a manufacturer’s quality systems information and an inspection of its manufacturing facilities. After approval, manufacturers must submit to the FDA any significant manufacturing changes made to the devices as well as annual reports of the device’s performance.

There is some concern among medical experts that this order from the FDA will cause the public to be more reluctant to use an AED when needed. “People already have a lack of comfort in using these devices,” Gordon Tomaselli, M.D., chief of cardiology at Johns Hopkins University in Baltimore, Md., and a past president of the American Heart Association, told The New York Times. “If word is out there that they don’t work anyway, people will be even more reluctant to do something that they were pretty nervous about to begin with.”

The FDA will accept public comment on the proposed order until June 22. If the order is finalized, the agency intends to exercise enforcement discretion for those manufacturers that notify the FDA of their intent to file a PMA in a timely manner. The FDA intends to exercise enforcement discretion for a year and a half.