Taking a more in-depth look at the data behind the March 2013 FDA announcement, CardioReady aims to support FDA commentary on AED safety and effectiveness
|JUNE 6, 2013 (Philadelphia, PA) – CardioReady, a national leader in helping to prevent fatalities from Sudden Cardiac Arrest (SCA) through its turn-key solutions and training, today released its findings from a comprehensive analysis of data underpinning the Food and Drug Administration’s (FDA) recent statements regarding its proposal to require premarket approval for Automated External Defibrillators (AED).
In its supplementary data investigation, CardioReady reviewed 46,003 incidents relating to the period 2005 – 2012. Notably, limited correlation was calculated between incidents with adverse lifesaving outcomes and Class 1 recalls (R2 of 0.17 for simple linear regression). Additionally, CardioReady determined that many incidents involved use of ‘professional grade’ AEDs by medical professionals – not laypersons. For example, in 62% of the total incidents, the AED user was coded as “OHP (Other Healthcare Professional)”. CardioReady therefore focused its analysis on the remaining (“Non-OHP”) incidents where it was more likely that the user was a layperson and utilizing a Public Access Defibrillator.
“While the FDA made a concerted effort to clarify both the public health benefits of AEDs as well as the FDA’s continued confidence in the efficacy and reliability of these devices, we were concerned that these important aspects of the FDA’s statements were not being conveyed and reinforced to the public audience who stands to benefit from the continued proliferation and use of lifesaving Public Access AEDs,” said John Ehinger, CEO of CardioReady. “As a result, we felt compelled to dig deeper into the data.”
CardioReady’s review of non-OHP incidents indicated that only 377 involved a fatality. While a reported fatality does not necessarily indicate that a problem with the AED impaired lifesaving capability, this figure equates to an annual average of 47 fatal incidents over the eight-year period, or 0.02% of the estimated 300,000 people who perish each year from SCA. CardioReady’s analysis also corroborated the FDA’s previous statements indicating low incidence rates in comparison to the estimated number of total Public Access Defibrillators in service. For example, 2012 Non-OHP fatal incidents equated to 0.006% of CardioReady’s estimate of slightly more than 1 million Public Access AEDs in service by the lay public in 2012. Data also confirmed year-over-year decreases in the number of Non-OHP fatalities in 2011 (43%) and 2012 (8%).
Ehinger added, “Importantly, our analysis shows the number of recorded AED incidents that occurred while a non-healthcare professional was using the device is very low. Equally, the ratio of all Non-OHP incidents to CardioReady’s estimate of Public Access Defibrillators in service has shown a steady decrease each year from 2005 through 2012. It’s our hope that this comprehensive analysis provides additional support of the FDA’s previous statements and helps to demonstrate the efficacy and utility of these devices, especially as more AEDs become available in the public space.”
Dr. Kevin Campbell, CardioReady’s Chief Medical Officer, reinforced, “It is vitally important that we continue to champion the proliferation of AEDs in the U.S. The FDA clearly recognizes the significant, positive impact that AEDs have on survival in out of hospital cardiac arrest. Through deployment and proper management of AEDs, we can reduce the incidence of sudden cardiac death in our communities.”
Ehinger concluded, “CardioReady is dedicated to raising awareness of AEDs and their vital role in combating the massive public health issue of SCA. Product evolution and improvement are important in all sectors, and we continue to agree with and support the FDA’s drive to ensure continued reliability of AEDs and promote manufacturing best practices. We hope that our review will aid both the FDA’s own efforts as well as dispel any misconceptions about the effectiveness of using an AED. Understanding the data fully is crucial to both of these objectives.”
For more information about CardioReady, 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.