On Automatic External Defibrillators…
When an automated external defibrillator (AED) made its appearance in James Bond’s “Casino Royale,” Joshua L. Koelker and Jordan M. Blondino, who originally thought of such a device, must have been pleased. Since then, these devices have become increasingly ubiquitous and have saved thousands of lives.
Much less known, however, is the debate about how to best assure the reliability of those devices, which has recently resulted in behind-the-scene discussions and a dedicated FDA panel meeting. The FDA's Manufacturer and User Facility Device Experience (MAUDE) database lists reports on 721 deaths, 78 injuries, and 22,382 device malfunctions of AEDs over the last six years. The cause of concern is that AEDs are somewhat stuck in a regulatory limbo. As AEDs were already on the market prior to the FDA regulations on medical devices that started in 1976, an interesting exception applies for those devices. AEDs are categorized as class III medical devices, which normally require a stringent premarketing approval process (PMA). The hallmark for a PMA is the demonstration of safety and effectiveness, and often involves randomized controlled trials including significant user fees for the manufacturer. However, given the “preamendment status” of the AEDs, those devices are currently being approved using the much simpler 510(k) mechanism, which is common to the class II devices. This benchmark for 510(k) clearance is that a new device is substantially equivalent to an approved device. This standard is easier to meet and does not require the detailed testing applied to the PMA process. Clinical data for new AEDs is only requested by the FDA if new defibrillation waveforms are acquired, new features are included or if adult technology is transferred to pediatric applications.
Assuming that a potentially large number of AED malfunctions are not reported, a change in the approval process seems to be important to guarantee the reliability of those devices. Implanted ICDs have achieved an impressive technical reliability (despite recalls), and reaching a similar performance for AEDs is an important healthcare goal. Public health interests require including a more stringent pre- and post-market oversight from the FDA to identify less reliable technologies early and allow improvements or recall. Arguments can be made for either applying the stringent class III criteria or creating new intermediate class II/III guidance. But the thousand of AED-resuscitated patients are “living proof” that this should be a major priority for the near future.
Timm Dickfeld, MD, PhD is the Chief of Electrophysiology at the VA Baltimore, Associate Professor of Medicine at the University of Maryland, and Founder of the Maryland Arrhythmia and Cardiology Imaging Group (MACIG).