CardioReady Issues Comment on the FDA Proposal to Increase Regulation of Automated External Defibrillators (AEDs)

Commending the FDA’s public affirmation of AEDs as a “proven clinical utility and great value for society and public health,” CardioReady cautions that these proposals must not slow the public proliferation of AEDs CardioReady, a national leader in helping to prevent fatalities from Sudden Cardiac Arrest (SCA) through its turn-key solutions and training, responded to the United States Food and Drug Administration’s (FDA) March 22 announcement proposing a premarket approval process for AEDs. "The FDA has confirmed the substantial benefits of AEDs, and like all medical devices, it is important to promote continued innovation to maximize functionality and reliability,” said Dr. Kevin Campbell, Chief Medical Officer for CardioReady. "While much of the public commentary to date has focused on issues with a small subset of AEDs, the more important question should center on what is being done to save the hundreds of thousands of people who die in the United States every year from Sudden Cardiac Arrest (SCA). Deployment and use of an AED within minutes of an SCA is the only practical lifesaving tool at our disposal. To stem this leading cause of death, we need AEDs to continue to proliferate. It is imperative that the general public understand that AEDs perform as intended in the vast majority of circumstances and are overwhelmingly effective lifesaving tools.” Research shows that the chances of SCA survival can increase from less than eight percent to more than 70 percent if an AED is used within three minutes of a person’s collapse. With AEDs being easy to use, affordable and highly effective, public expectations of safety and care have increased, which has led more businesses and organizations to pursue comprehensive AED programs. Echoing Dr. Campbell’s sentiment, John Ehinger, CEO of CardioReady, said, “The daily mission of our organization is to save victims of cardiac arrest, and we are concerned that an incomplete understanding of last week’s FDA announcement may inappropriately—and negatively—impact public opinion about AEDs. It is crucial to view the FDA proposal from an informed perspective. The FDA has affirmed its confidence in the AEDs on the market and has indicated that users should feel confident that these devices will work when needed. Equally, the FDA is ‘not removing currently distributed AEDs from the market,’ and given the nature of SCA, it is important to recognize that AED failure does not cause death. Thus, greater emphasis needs to be placed on the expanded public access, deployment and use of AEDs as it is only through doing this that we can combat the more than 300,000 SCA deaths occurring each year in this country alone. As a company, we fully support all reasonable efforts to improve this lifesaving technology. Should the PMA process be adopted, we are optimistic that it will not impair AED availability, and we are confident that it will enable greater public visibility on the efficacy and lifesaving benefits of AEDs.” For more information about CardioReady and how its services can help organizations with AED maintenance, tracking and training, please visit www.cardioready.com. About CardioReady Headquartered in suburban Philadelphia, CardioReady is an innovative company committed to improving survival from Sudden Cardiac Arrest. With a team comprised of professionals skilled in medicine, risk management, and emergency response services, CardioReady offers its clients true turn-key solutions to save lives and manage exposure to cardiac incidents across North America.