The FDA proposed last month that makers of automated external defibrillators (AEDs) be required to submit premarket approval (PMA) applications for these devices. Why? They have receive 45,000 reports – not a typo – of failures of these devices in the last 8 years. My gosh, I’m surprised they are so ubiquitous that they even have been used 45,000 times.
But these things – these literally life and death machines – have had 8 recalls in the last eight years. Pathetic. The problems usually involve the AEDs powering off during use, error messages caused by software anomalies or just component failure.
I don’t trust these things. Yet I still dutifully carry one on the court when I play tennis with my father. Can you imagine the horror of needing to use one of these things and you are getting an error message?
What does all of this mean? AEDs are now pre-amendment devices that can get on the market through the less-rigorous 510(k) process, meaning they are similar enough to a pre-existing device that they don’t require clinical trials to establish safety and efficacy. Now they need a PMA which is a more lengthy process that costs about a quarter of a million dollars. But this backdoor 501(k) process has caused pain in so many, most notably with metal-on-metal hip replacements.