CardioReady Supports FDA’s Decision to Reclassify AEDs

In March this year, the U.S. Food and Drug Administration (FDA) proposed that automated external defibrillators (AED) be reclassified, requiring a pre-market approval rather than the less stringent 510(k) clearance. The crackdown came after approximately 45,000 adverse event reports between 2005 and 2012 associated with the devices’ failure. The agency’s move to reclassify the devices is an effort to improve the quality of what it deems to be a life saving device.

Philadelphia, Pa.-based CardioReady LLC, a company that provides turn-key certified cardiac emergency response programs to organizations aimed at preventing fatalities from sudden cardiac arrest (SCA), has responded with support for the FDA’s action. In scrutinizing the FDA’s data more closely, CardioReady found that AEDs found in public spaces were more effective than the agency’s report suggested. CardioReady also backs the agency’s decision to reclassify the devices, as it believes the FDA’s attention to the matter supports the valuable nature of AEDs and their role in saving lives.

In its supplementary data investigation, CardioReady reviewed 46,003 AED adverse incidents reported between 2005 and 2012. Notably, limited correlation was calculated between incidents with adverse lifesaving outcomes and Class 1 recalls (R2 of 0.17 for simple linear regression). CardioReady determined that many incidents involved use of “professional grade” AEDs by medical professionals, not laypersons. For example, in 62 percent of the total incidents, the AED user was coded as “OHP,” or 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 using a public access defibrillator.

Analysis 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 annually over the 8-year period, or 0.02 percent of the estimated 300,000 people who died 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 percent 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 percent) and 2012 (8 percent).

“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. 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.”

“It is vitally important that we continue to champion the proliferation of AEDs in the U.S.,” stressed Kevin Campbell, M.D., CardioReady’s chief medical officer. “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.”

“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,” added Ehinger. “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.”