SCA Foundation Urges HHS to Require FDA to Provide Rationale for its Proposal to Increase Regulations of AEDs

The Sudden Cardiac Arrest Foundation has written to U.S. Health and Human Services Sec. Kathleen Sebelius, asking her to request that the Food and Drug Administration provide a public health rationale for its proposal to increase regulations of automated external defibrillators (AEDs). Following is the text of the letter.

Letter from Sudden Cardiac Arrest Foundation to U.S. Department of Health and Human Services

Re: Request to HHS to require the FDA to provide an evidence-based justification for its proposal to increase in regulations related to automated external defibrillators

Dear Secretary Sebelius:

By way of introduction, the Sudden Cardiac Arrest Foundation is a national 501(c)3 community benefit organization dedicated to raising awareness about sudden cardiac arrest (SCA) and saving lives. We are writing to express our concerns about a proposal by the Food and Drug Administration (FDA) to increase the level of regulation of automated external defibrillators (AEDs) from 510(k) premarket notification to premarket approval (PMA), rather than reclassifying AEDs to Class II, the level of regulation the agency has successfully implemented for this device for more than 25 years. Now, based on medical device reports and recalls, the FDA has mischaracterized the safety of this device, which rarely fails during use.[i]

Summary

We disagree with the FDA’s proposal for the following reasons:

• The number of adverse events is extremely small and the risk of device failure during use is infinitesimal.
• Early defibrillation is the most effective known intervention for restoring circulation after SCA. For each minute that passes between collapse and defibrillation, survival rates decrease 7-10%.[ii]
• The use of AEDs by bystanders accomplishes the earliest possible defibrillation (outside of wearable or implanted defibrillators).
• Increased use of AEDs by bystanders can only occur if the devices are more widely available and if the public is educated about its critical role in providing early defibrillation.
• The FDA’s proposed regulatory changes will result in increases in device prices, thus reducing access, and will stifle innovative changes that could lead to reduced costs.
• The FDA’s proposed regulatory changes are unlikely to achieve measurable safety improvements, but are very likely to mean that fewer SCA victims will be given a chance to survive.

We have expressed our concerns to the FDA in multiple communications, most recently in June in response to a solicitation for comments on the matter. (See attachments.) We are now requesting that you require the FDA to provide an evidence-based public health justification for its proposed action.

Details

By way of background information, about 1,000 people (359,400 annually) experience SCA outside hospitals each day in the U.S. and, on average, only 10 percent of victims survive.[i] However, a prospective multi-center clinical trial has demonstrated that survival rates increase to nearly 40 percent when bystanders intervene quickly by giving CPR and using AEDs before EMS arrives at the scene.[ii] And, as reported just last week on NBC Nightly News, survival rates in one city (Rochester, Minnesota) now approach 60%, thanks to rapid use of AEDs by police officers.[iii] If the national average survival rate increased to even 25%, more than 50,000 additional lives could be saved each year.

In contrast to the limited data presented by the FDA to support its proposal, a vast body of clinical research convincingly shows that AEDs are safe, effective, and reliable. For example, the Public Access Defibrillation trial, a prospective clinical study funded by the National Institutes of Health (NIH), found that “AEDs have an exceptionally high safety profile when used by trained lay responders.” Investigators from multiple centers reported there were no inappropriate shocks and no failures to shock when indicated.[iv] Another NIH-funded study that looked at the use of AEDs in the home also found there were no inappropriate shocks.[v] Similarly, research conducted in Chicago area airports determined that AEDs were used safely and effectively by untrained lay responders.[vi]

We are further convinced of the value of AEDs as a result of interaction with, and research conducted among, members of our growing network of SCA survivors, most of whom were saved thanks to immediate use of AEDs. In addition, 1,372 people, including many survivors, have signed a petition we initiated urging the FDA to refrain from increasing the effective level of AED regulation and instead designate AEDs as Class II devices to keep them readily accessible.[vii]

Given the decades of research clearly demonstrating the safety and efficacy of AEDs, and the growing community of SCA survivors, we believe it is in the public’s best interest to increase access to this lifesaving technology, not create unnecessary obstacles to access.

The proposed FDA approach, however, will inevitably decrease access to AEDs since it will lead to increases in device costs, which in turn will be passed on to AED purchasers. Although prices have declined over the years, these sophisticated devices still cost about $1,200 each, and price is a primary inhibitor to widespread access.

Furthermore, the FDA’s proposed approach is unlikely to significantly improve the safety of the devices, which have already been proven by multiple studies to be safe. It is important to note that AEDs have been successfully regulated for at least 25 years under less costly and cumbersome requirements than those that are now proposed. Today, well over a million AEDs are deployed in the U.S. for use by emergency responders and laypersons in public locations (e.g., airports, schools, government office buildings) and in private homes.

In conclusion, we urge the Department of Health and Human Services to intervene in this critical public health matter and recommend that unless there is an evidence-based public health risk, the FDA should withdraw its proposed regulatory action.

Perhaps David Belkin, Esq., a cardiac arrest survivor and member of the Sudden Cardiac Arrest Foundation Board of Directors, says it best. In his testimony before the FDA he said, “It’s essential to keep in mind that AEDs do not cause death. By definition, they are used to help restore life for people who die suddenly. If increasing regulations of AEDs reduces their distribution and access due to increased costs and regulatory hurdles, progress toward improving survival rates nationwide will be impeded.”

Thank you for your time in considering our position.

Sincerely,

Norman S. Abramson, MD, FACEP, FCCM, Chairman, Board of Directors  

Mary M. Newman, MS, President

Attachments:

• January 11, 2011 correspondence to FDA
• “Reclassifying Defibrillators, February 3, 2011 Letter to the Editor of The New York Times
• November 2, 2012 correspondence to FDA
• “AEDs Save Lives: Let’s Keep Them Readily Available,” December 14, 2012, Huffington Post blog
• December 17, 2012 correspondence to FDA
• June 5, 2013 correspondence to FDA

[i] http://circ.ahajournals.org/content/127/1/e6