A Food & Drug Administration advisory committee’s support for stiffer controls on automated external defibrillators means the devices could be slated for the agency’s toughest regulatory process.
The FDA asked its Circulatory System Devices Panel to weigh in on whether AEDs, designed to restore a normal heartbeat after cardiac arrest through automated electric shocks, need more scrutiny on their way to reaching the marketplace. The federal watchdog logged thousands of complaints related to the safety of the devices.
Although there was no formal vote, most panel members supported bumping AEDs to Class III than keeping them at their current Class II level. That change would mean the devices would need to pass pre-market approval muster, rather than the less stringent 510(k) clearance process they’re currently subject to. The more arduous PMA pathway mandates stricter manufacturing guidelines and more information reporting.
The debate on AEDs became more complicated after a study published today in the New England Journal of Medicine affirmed the value of the devices in public places, such as airports or casinos.
The research showed that when an ambulance arrived at the scene of a cardiac arrest in a public place, 60 percent of the people who collapsed had heart rhythms that allowed the use of an AED. At home, however, only 35 percent of the people might have been helped by the devices.
The authors of the study "surmise that age and coexisting illnesses are responsible and that the location of sudden cardiac arrest may be a surrogate for underlying disease severity," cardiologist Dr. Gust Bardy wrote in an editorial accompanying the article.
"The authors conclude that perhaps AEDs should be reserved for public locations and cardiopulmonary resuscitation (CPR) should be taught more broadly, as the better path to improving survival from sudden cardiac arrest," Bardy wrote.