Blood pressures are rising over a move by the Food and Drug Administration (FDA) to classify automated external defibrillators (AEDs) as a Class III high-risk medical device, requiring a more rigorous pre-market approval (PMA) application process. The FDA is expected to make a final decision by the end of this year.
Currently, AEDs are classified as a Class III device, but due to a grandfathering clause, they have been regulated as Class II devices, entering the market following FDA clearance of a 510(k) submission, rather than the more laborious PMA process. There are an estimated 1.5-2 million AEDs deployed in the U.S.
In 2009, the Government Accounting Office recommended that the FDA review and reclassify grandfathered devices, such as AEDs. In January 2011, the FDA assembled an advisory panel to conduct an exhaustive analysis of AEDs. The panel reviewed adverse event reports, recalls, information from FDA inspections of AED manufacturing facilities and peer-review literature. It was their recommendation that the AEDs be classified as a Class III device.
The FDA classifies medical devices into one of three categories based on the level of control necessary to provide a level of safety and effectiveness. Class I devices are generally exempt from a PMA process. Class II requires that manufacturers submit the 510(k) pre-market notification. Manufacturers of high-risk medical devices in the Class III category, including those that support or sustain human life or are substantially import in preventing the impairment of human health, are required to submit a PMA.
AED manufacturers have already expressed concerns that the reclassification will increase cost and delay future technological innovations. They argue that special controls already exist, providing reasonable assurances of safety. Pleas from public safety and other organizations are also urging the FDA to reconsider the designation. The Sudden Cardiac Arrest Foundation has posted a petition and sample letter on its website (www.sca-aware.org) encouraging public health professionals to contact the FDA. According to the letter, increased regulatory costs will hamper the ability of public entities, such as schools, public safety agencies, small businesses and non-profit organizations, to purchase AEDs. If these groups, considered the primary purchasers of public access AEDs, are unable to provide them in public places, fewer AEDs will be available when needed and sudden cardiac arrest (SCA) survival rates will decline. The letter asks the FDA to consider alternate pathways to ensure safety and efficacy standards.
Widespread deployment of AEDs is a critical component of many SCA programs. The Resuscitation Outcomes Consortium (ROC) study found that the average survival rate increased 38% among SCA victims who received both CPR and treatment with AEDs by bystanders.(1)
Orcas Island Fire and Rescue Division Chief Patrick Shepler, BS, NREMT-P, noted in his letter to the FDA, that both the American Heart Association and International Liaison Committee on Resuscitation have identified defibrillation as a Class I intervention.
The Review Process
The FDA’s 15-member Circulatory System Devices Panel determined that AEDs should remain a Class III device based on the risk to health associated with potential malfunctions. Over the past five years, the AED industry has conducted approximately 68 recalls, affecting hundreds of thousands of devices. In addition, the FDA has received an increasing number of adverse events as medical device reports regarding AEDs. Since 2005, the number of reports has more than doubled, from 3,336 to 6,625 in 2010. The vast majority of these events involved a malfunction. However, it's important to note, that unlike many other medical devices, a significant portion of these events did not involve a patient. The most commonly reported event was a device error message. The second most common report was a failure to power up. Both often occurred during the self-testing process. The actual number of malfunctions is unknown because many AEDs are under the control of citizens who may not be aware of the FDA’s medical device reports.
In the end, the panel recommended that AEDs should remain a Class III medical device. “The panel feels that certainly additional regulatory controls are needed because there is a concern that their manufacture many not be adequately regulated [and] than that the current long-term monitoring of these devices is inadequate,” panel chair John Hirshfeld, MD, cardiologist at the University of Pennsylvania Hospital in Philadelphia, said in a statement. Although the panel acknowledged that subjecting AEDs to randomized clinical trials would be a waste of effort. “What would be optimal for AEDs is a sort of ‘class III lite,’” he says.
A modified approach that would permit AEDs to be classified as Class II devices, but with special controls was considered, allowing manufacturers to respond more nimbly to the rapid pace of AED development. Previous FDA decisions regarding humanitarian use devices were cited as precedent. However, the FDA expressed significant concerns that the number and types of special controls required would create a parallel regulatory paradigm and rejected this option. In the executive summary of the recommendations, the FDA acknowledged that a higher regulatory threshold may inhibit device development and innovation, but “considers this a tradeoff with the need to evaluate the appropriate level of testing for AEDs.”
Meeting notes, presentation and an executive summary is available here.
1. Weisfeldt ML, Sitlani CM, Ornato JP, et al., on behalf of the ROC Investigators. J Am Coll Cardiol. 2010;55:1,713--1,720.
Class I Recall Issued for Certain HeartSine Public Access Defibrillators
On Nov. 19, the U.S. Food and Drug Administration (FDA) issued a Class I recall for certain HeartSine Samaritan 300/300P PAD devices. The devices have been found to intermittently turn on and off, which may eventually deplete the battery. In addition and separately, certain Samaritan 300/300P PAD devices containing early versions of the battery management software may misinterpret a temporary drop in battery voltage as signaling a low battery, resulting in the device turning itself off. HeartSine Technologies, Limited sent a letter to customers on Sept. 11, 2012, describing the problem and providing instructions for correction.
Samaritan 300/300P PAD devices with the following serial numbers are affected by this recall: 0400000501 to 0700032917, 08A00035000 to 10A0070753 and 10C00200000 to 10C00210106. Affected devices were manufactured and distributed from 08/01/2004 to 01/31/2011.
Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death. According to the FDA, no deaths or injuries have been reported to date associated with the on/off issue. However, HeartSine has received five reports of death for which the company has not been able to rule out the possibility that the events may have been related to the battery management software issue.
For more information about the HeartSine Samaritan 300/300P PAD devices, go to the FDA website.