As any engineer can tell you, product reliability is a huge challenge. How exactly are you supposed to prove a device will last for 5 years, when it will be obsolete in 2? Consumers are a fickle lot; if their shiny new iPad works flawlessly, they will brag to a few friends. If the gadget fails to match their every expectation, they will turn to the internet and tell the world. In the realm of medical devices, the challenge is a bit more acute. Automated external defibrillators (AED’s) are an amazing, life-saving device; even in the hands of the most minimally trained responder, an AED can analyze a troubled heart and deliver a corrective jolt. Surprising as it may seem, they are not always reliable. If considered as Class III medical devices (“…intended to support and sustain life…”), they would require two years and nearly $1 million dollars worth of tests and clinical trials. By claiming they are substantially the same as existing devices, manufacturers can invoke the 501(k) process and skip all that. If you are planning on having a heart attack any time soon, grab a pencil and paper and Google “AED Reliability”.
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