THE FDA WILL NOW REGULATE AUTOMATED DEFIBRILLATORS, ELIZABETH TRACEY REPORTS
Automated external defibrillators, or AEDs, can be found in malls, airports and other public spaces, for use by passersby who witness someone have an apparent heart attack, and are credited with saving lives. But until now, the FDA hasn’t regulated these devices. Rick Lange, one member of the FDA committee convened to discuss AEDs and professor of medicine at Johns Hopkins, says that’s about to change.
LANGE: Oftentimes the AED doesn’t discharge is because the rhythm doesn’t warrant it, so that’s not really a failure, but there are clearly times where the AED would clearly fire itself up and get ready and then shut itself off, so these are problems either with the software or some of the electrical components. So the FDA is going to take a more active role in their design and in assessment of their components, their manufacture and the ongoing quality control of these devices. :28
So hopefully more people who suffer sudden cardiac arrest will be saved. At Johns Hopkins, I’m Elizabeth Tracey.