FDA To Require More Stringent Approval Process for Automated External Defibrillators

Federal regulators have issued new rules on automated external defibrillators (AEDs), tightening the approval process in an effort to make them safer following a number of defibrillator recalls issued in recent years. 

A final order (PDF) was issued by the FDA on January 29, requiring premarket approval applications for AEDs and their accessories. This means that the devices will no longer be approved via the FDA’s controversial 510(k) fast-track approval process, which has been used in recent years for many different types of medical devices considered to be substantially equivalent to already existing products.

AEDs are used in emergency rooms, schools, office buildings and other public places to provide emergency electrical stimulation to cardiac arrest victims. When they function, they can prevent almost certain death when the heart stops. However, if they malfunction, then the opportunity for life-saving measures can be lost.

According to the FDA, between January 2005 and September 2014, the agency received about 72,000 reports of AED failures. There have been 111 AED recalls issued in that same time period. Those recalls have affected more than two million devices.

Going through the premarket approval process will require manufacturers to provide information on quality control, prove that the devices work as intended, and allows the FDA to inspect AED manufacturing facilities before the devices are put on the market. Manufacturers will also be required to notify the FDA of any changes they make to the devices that could impact their effectiveness. They will also be required to provide annual reports on the performance of AEDs once they are approved.

Enforcement of the new rules is slated to begin on July 29, 2015 for manufacturers who notify the FDA of their intent to seek a PMA by April 29, 2015. Currently marketed AEDs are grandfathered in under current rules until January 29, 2020, at which time they will be subject to the new regulations.

Manufacturers Failed to Address FDA Concerns

The FDA has warned of the coming changes since 2010, when the agency sent a letter to AED manufacturers warning them that they could face more stringent regulations if they did not take action to address recurring problems.

That year saw numerous AED recalls.

In February 2010, Cardiac Sciences recalled about 12,200 automated external defibrillators (AEDs) because the units could fail when needed. That recall was later expanded to 280,000 units when the FDA warned that the defective components were widespread throughout the company’s products.

Defibtech also recalled 5,400 rechargeable defibrillator battery packs in June 2010 due to defects that could prevent them from providing power.

Medtronic’s Physio-Control Inc. subsidiary has had to make two major recalls of LIFEPAK defibrillators that year. In April 2010, a recall of the LIFEPAK 15 defibrillators was announced because the units could turn off and on by themselves. In July of the same year about 43,000 LIFEPAK 20 and LIFEPAK 20e units were recalled due to possible power failures.

However, the FDA says the problems continued unabated, requiring the new regulations.

“Automated external defibrillators save lives,” FDA’s acting director for the Office of Device Evaluation, Dr. William Maisel, said in a press release. “These changes to the way these devices are reviewed will allow us to more closely monitor how they are designed and manufactured. This will go a long way towards correcting long-standing problems and ultimately improving the reliability of these devices.”