The dark side of medical devices

There is quite a bit of buzz around the new Netflix film: The Bleeding Edge. It blames a lot the medical device industry (and robotics surgery within) being negligent and unsafe. Despite all the hard work of FDA, the stringent certification procedure, given the complexity of modern medical devices, it is no wonder accidents, design flaws still happen. Are we doing better or worth than the biopharma? Hard to tell... IEEE is now putting together an ethical standard for robots, and medical robots within, to provide some guidelines for the manufacturers. 

"A terrifying new documentary carries a stark warning that a nightmare has been lurking in the medical industry for decades and it might be in your body.  The Bleeding Edge, which premieres on Netflix, examines the $400bn medical device industry responsible for products such as hip implants and robotic surgeons, through the lens of five products that have wreaked havoc on the lives of thousands.  “A wide range of people know about the problems with pharmaceuticals, but very few people know about the medical device industry and the fact that it is even less regulated than pharmaceuticals,” director Kirby Dick told the Guardian. “We felt it was very important that the public, doctors and policymakers know about this because right now medical device companies can get away with just about anything.”

A number of factors are responsible for the catastrophes captured in the film, but the documentary lasers in on the FDA’s 510(k) pathway for approving medical devices.  To approve a prescription drug, medicine must be tested in humans, the manufacturer must compile data on its effects and a panel of FDA scientists must give it final approval.  The same process is not required for medical devices. Those can be approved if the manufacturer demonstrates that it is equivalent to a device on the market – even if the device it is being compared to has been recalled.  “Even if we take these five devices that we focus on the film off, the problem isn’t solved,” warned Ziering. “It’s a system that needs to be much more vigilantly regulated.”  Despite the frightening situations depicted in The Bleeding Edge, portraits of hope come from people fighting back."

Source: The Guardian