Patient safety? Nah I’m good

When a medical device malfunctions, it is up to the doctor to alert the hospital, the hospital to alert the device maker, and the device maker to alert the FDA 30 days later. Not exactly a fast process. Well the US House of Representatives just approved a renegotiated agreement between the FDA and device industry that would push this 30 days back to three months. While device makers are happy because this agreement also includes lowering the proposed annual user fees, it has some watchdog groups and critics up in arms and bringing up all the bad memories the device industry wishes they could forget. Who knows, maybe malfunctioning trends will become more apparent with this extension, but it certainly doesn’t scream “patient safety.”