Please Don't Make It Harder to Save Another Life by Reclassifying AEDs

This blog was previously published in The Huffington Post.

The Sudden Cardiac Arrest Foundation has launched a petition to the Food and Drug Administration to keep automated external defibrillators (AEDs) readily accessible for victims of sudden unexpected cardiac arrest, rather than increase regulatory hurdles that will hinder their deployment. The FDA is expected to make a decision before the end of the year. Please consider signing the petition today.

Background

Every day in the U.S., about 1,000 people of all ages suffer sudden cardiac arrest (SCA) outside hospitals and, on average, only one in 10 victims survives.(1) However, when bystanders provide cardiopulmonary resuscitation (CPR) and use automated external defibrillators (AEDs) before emergency medical services personnel arrive, as many as four in 10 victims survive. (2)

SCA, which differs from a heart attack, is an abrupt, unexpected pulseless condition. It is usually caused by ventricular fibrillation, an abnormality in the heart's electrical system. When SCA occurs, blood stops flowing to the brain, the heart and the rest of the body, and the person collapses. Within minutes, the victim is clinically dead and will remain so unless someone (like you or me) helps immediately.

The best way to help is to call 911, start CPR, and use the nearest AED. An AED is a portable, user-friendly device that automatically diagnoses a potentially life-threatening heart rhythm and delivers a therapeutic shock, if needed, to restore a normal heartbeat. The AED cannot hurt the victim, the rescuer or other bystanders, as long as it is used properly.

The survival of Walter "Josh" Watts is a case in point. The 21-year-old was saved from sudden cardiac death last spring through prompt CPR and use of an AED by fellow students at College of the Ozarks. Walter is a member of our growing network of SCA survivors -- people who readily attest to the value of AEDs.

The Issue

The Food and Drug Administration (FDA), however, is considering increasing regulations for AEDs by reclassifying them as Class III medical devices that require pre-market approval. This means that the lifesaving public safety devices, which have been already been proven to be safe and effective by decades of research, will have to undergo new, complicated, time-consuming, expensive clinical trials before being approved for use in the marketplace. As a result, AEDs will inevitably become much more expensive and much less readily available. The negative public health impact will be severe. Inevitably, fewer victims will survive.

A Reasonable Alternative

We urge the FDA to consider designating AEDs as Class II medical devices with special controls. This will raise the bar for all manufacturers by formalizing the hard-won experience of the last 20-plus years in key areas such as human factors and device readiness. Since AEDs place the power to save lives in the hands of laypersons, some special consideration regarding regulation is appropriate. Class II designation with special controls will not only ensure the safety and effectiveness of AEDs, it will also allow innovation to continue. As a result, the cost of AEDs will decrease and deployment will increase. Ultimately, more lives will be saved, and more families will be spared the painful loss of loved ones snatched away too quickly.

Call to Action

Please join the hundreds of individuals who have already signed a petition urging the FDA to keep AEDs accessible for victims of sudden cardiac arrest -- people like Kristin, who said, "Five years ago, the combination of bystander CPR and an AED saved by life. My children, ages 8 and 6, came so close to not knowing me. Please don't make it harder to save another life by reclassifying AEDs." Click here to sign.

For more information, click here.

References:

(1) Go AS, Mozaffarian D, Roger VL, et al. Heart disease and stroke statistics--2013 update: A report from the American Heart Assoociation. Circulation.2013: published online before print December 12, 2012, 10.1161/CIR.0b013e31828124ad:e160-161.

(2) Weisfeldt ML, Sitlani CM, Ornato JP, et al., on behalf of the ROC Investigators. J Am Coll Cardiol 2010;55:1713-1720