01 Mar '12, 5pm

The Shocking Truth About Defibrillators

The Shocking Truth About Defibrillators

How did the AED industry get into this state? It has to do with a quirk in the law regulating medical devices. If you count AEDs as Class III devices—those intended to support and sustain life—then manufacturers must produce extensive efficacy, safety, and reliability data, usually provided by large-scale clinical trials. This process can cost upward of US $800 000 and take two years. Manufacturers can, however, get around those requirements, thanks to what’s called the 510(k) process, which effectively removes AEDs from Class III. The process requires merely that a new AED be “substantially equivalent” to any AED on the market. The 510(k) system was originally intended as a temporary measure to grandfather in devices already on the market in 1976. More than 30 years later, the process is still being used to clear AEDs, as well as 25 other high-risk products , including im...

Full article: http://spectrum.ieee.org/biomedical/devices/the-shocking-...

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