External Defibrillator Problems May Lead to Stricter FDA Requirements

Federal regulators are proposing more stringent standards for the manufacture of external heart defibrillators, including a stricter approval process, to combat thousands of reports involving defibrillator malfunctions. 

This week, an FDA advisory committee will weigh the possible effectiveness and feasibility of a new external defibrillator improvement initiative, which proposes to require that automated external defibrillators (AEDs) be required to go through a strict premarket approval process. This would exclude the devices from participating in the FDA’s 510(k) approval process, which is a fast-track program that only requires that they be substantially equivalent to other medical devices already on the market.

The agency is also working with the University of Colorado’s Department of Emergency Medicine to develop a defibrillator registry and will work with the medical device manufacturers to develop new manufacturing standards.

Concerns over the safety of external defibrillators, especially AEDs, has been growing as the FDA has increasingly received reports of malfunctions and announced defibrillator recalls. From January 1, 2005 to July 10, 2010 the FDA received more than 28,000 medical device reports on problems with defibrillators, including malfunctions that led to patient deaths.

According to the FDA, there were 68 external defibrillator recalls during the same time period, with the number of recalls growing each year. In 2005, there were nine recalls, but in 2009 there were 17. During the same time period, the FDA received more than 28,000 MDRs of defibrillator problems. That number, too, increased over the years from 4,210 reports in 2005 to 7,807 reports last year.

In November, the FDA sent a letter to medical device manufacturers warning them that if they could face stricter regulation of external defibrillators if they did not take action to address the recurring problems.

Last year saw a number of major defibrillator recalls and other defibrillator developments. In February, 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 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. In April a recall of the LIFEPAK 15 defibrillators was announced because the units could turn off and on by themselves. In July about 43,000 LIFEPAK 20 and LIFEPAK 20e units were recalled due to possible power failures.

The meeting of the Medical Devices Advisory Committee’s Circulatory System Devices Panel is scheduled for January 25 and 26 from 8 a.m. to 6 p.m. at the Holiday Inn in Gaithersburg, Maryland.