Action could reduce access to lifesaving devices
GAITHERSBURG, Md - The Food and Drug Administration (FDA) Circulatory System Devices Panel met Tuesday to discuss and make recommendations regarding the regulatory classification of automated external defibrillators (AEDs). AEDs are used to resuscitate people who suffer sudden cardiac arrest (SCA) and are clinically dead.
The panel considered whether to reconfirm that AEDs should remain Class III high-risk medical devices or be reclassified as Class II moderate-risk devices. Class II devices are subject to a pre-market “510(k)” notification process, whereas Class III devices are subject to a more rigorous pre-market approval (PMA) application process.
AEDs currently are considered Class III devices, but due to a grandfathering clause, they have been regulated as Class II devices.
The issue arose after the Government Accounting Office (GAO) recommended in 2009 that the Class II review process should not be available for Class III devices. Such devices should either be reclassified as Class II devices, according to the GAO, or be required to follow the Class III process.
During yesterday’s hearing, the FDA stated that there have been more than 22,000 reports of AED malfunctions and 68 AED recalls in the past five years, affecting hundreds of thousands of devices. (An estimated 1.5-2 million AEDs are deployed in the U.S.) The FDA acknowledged that many of the malfunctions occurred during the device self-testing process and not when being used on patients. “It is possible that the final determination is that the device did not cause or contribute to the death,” the FDA stated in its report to the panel.
Nevertheless, the FDA recommended that AEDs should remain Class III medical devices and undergo the PMA process, noting that it would need to create special controls if AEDs were reclassified as Class II devices. If AEDs are reclassified as Class III devices, AED companies would have to pay a PMA application fee of more than $236,000, or $60,000 for a small business. The fee for a 510(k) review process is about $4,000 and about half that for small companies.
AED manufacturers supported reclassification from Class III to Class II both in petitions submitted previously and during yesterday’s hearing, stating that special controls already exist and can provide reasonable assurance of the safety and effectiveness of AEDs. These include testing to industry standards, following American Heart Association guidelines, device labeling, guidance documents, and post-market surveillance. Manufacturers also expressed concern that reclassification could stifle innovation.
Notably absent from the discussion was the fact that AEDs do not cause death; by definition, they are only used on people who are already dead. Other considerations include these facts:
- There are about 295,000 cases of out-of-hospital cardiac arrest each year in the U.S., and the average survival rate is 7%. That rate increases dramatically to 38%, when AEDs are used by bystanders .
- Only half of all SCA victims treated with AEDs are in heart rhythms that can be helped by the devices. For the rest, no shock is advised.
- Anyone can report a device malfunction. Since AEDs are designed for use by laypersons, reports can be filed by laypersons who may not understand the capabilities of the devices.
- The FDA investigates only 30% of device malfunctions, so their cause is largely unknown.
- After the day-long meeting, the majority of panelists seemed to agree with the FDA recommendation, although there was no official vote.
“It is better to have [these devices] as Class III,” said panelist Frank LoGerfo, MD, a vascular surgeon at Beth Israel Deaconess Medical Center. “We want to make sure the device works when the time comes for it to be used, and we want a report after as to how it worked.”
Panelist Myron L. Weisfeldt, MD, a pioneer in SCA research and chairman of the department of medicine at Johns Hopkins University, said that while the reported malfunctions are important, they occurred most often during device self-testing, not when being used to revive patients. SCA victims in ventricular fibrillation who are treated with AEDs have a 42 percent survival rate, he said.
“The value of current AEDs that are available to emergency care providers and the public have saved many lives and were approved by the FDA under provisions of the 510(k) process,” said Weisfeldt. “Despite the data presented by the FDA, I see no compelling reason to begin a more expensive and demanding process of classifying these devices as Class III. It is most important to note that most other defibrillators in use, are approved as Class II devices with a process similar to the 510(k) process. The problems that need to be addressed, related to the concerns of the FDA, we were told, could be addressed using provisions for special controls under a Class II classification.”
The Sudden Cardiac Arrest Foundation expressed a similar viewpoint in its written testimony, calling for the reclassification of AEDs as Class II devices with special controls designed to ensure safety and efficacy. “We are concerned that a Class III designation could impede access to AEDs, thus dramatically reducing the chances of survival for thousands of sudden cardiac arrest victims each year,” said Norman Abramson, MD, FACEP, FCCM, board chairman, and Mary Newman, president.
“Increased distribution of AEDs and public access to the devices has resulted in increased survival rates among people who suffer sudden cardiac arrest outside the hospital,” said David Belkin, Esq., an SCA survivor and Foundation board member, in his testimony before the panel yesterday. “If designating AEDs as Class III devices reduces their distribution and access—due to increased costs and regulatory hurdles—progress toward improving survival rates nationwide could be stymied.”
A summary of Tuesday's proceedings is posted at this link and a transcript will be posted in 30-50 days, according to James Swink, Designated Federal Officer of the FDA's Medical Devices Advisory Committee. "The FDA will conduct a thorough review of the recommendations made by the panel and act accordingly," he said.
 American Heart Association. Heart Disease and Stroke Statistics – 2009 Update. Dallas, Texas: American Heart Association, 2009.
 Weisfeldt ML, Sitlani CM, Ornato JP, et al., on behalf of the ROC Investigators. J Am Coll Cardiol 2010;55:1713-1720.
 Research Outcomes Consortium
SOURCE: Sudden Cardiac Arrest Foundation