FDA Tightening Regulatory Requirements For Some Medical Devices

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Support for this podcast and the following message come from almond board of California almond farmers rely on healthy honeybees. So they funded more than a hundred research projects supporting be health more than any other crop group grow. What you know at almondsustainability dot org. The food and Drug administration is being forced to intensify. Scrutiny of medical implants. Now when you hear the word implants, it's easy to think of cosmetic surgery, but the word here includes a growing number of potentially lifesaving devices, the doctors place inside the patients, the problem is many of the devices have been breaking down like farm member station. WPN in Nashville reports on the effort to address that. There's no doubt that surgically implanted devices improve lives drug pumps, nerve stimulators, spinal rods. But the devices can also do serious damage like they have to Michel keel. It ruined my. Yes, it did. I'm sending near tears keel had. Problems with the leaky bladder. So a surgeon stitched a flexible mess strap insider pelvis, but the strap hardened and started cutting her insides the pain kept her from turning to her job in Michigan. As a hairdresser removing all the bits and pieces embedded in the scar tissue is required, multiple surgeries and resulted in chronic infections, kill can see why her doctor thought the high tech mesh would help. But she also now feels like she was a Guinea pig. We were the Chester's. There was no animal testing done. We were the animals for devices in which a failure could obviously be life. Threatening regulators have required some sort of human testing. But medical author Jeannie Linzer says the FDA now acknowledges that even some seemingly inert devices have caused major problems. So we have things like metal on metal hip, which outside the human body seemed to function just fine. They put them in little machines. They Rackham back and forth. They don't break. They put them inside people and something very different happens. Linzer just wrote a scathing book about the device industry and says she was dumbfounded to find out. How many devices never went through human testing like drugs? Do that's in part due to an expedited approval process known as five ten k it allows manufacturers to bypass many requirements by showing their product is very similar to something already in use. You just say your devices like an old device, and the device was never tested nor with your device in practice. Sometimes the basis for a whole family tree of devices turns out to be defective pelvic mashes a good example and a product for which the FDA has started requiring some human testing. But manufacturers have pushed back against calls to bring regulation of medical devices in line with medication Scott Whitaker of add them. It speaks for industry. Giants like striker Johnson and Johnson and mid Tron IQ testing should be as complete Hannah's thorough and his ethical and as appropriate as possible. But it doesn't all fit the same. And can't off it the same standard, not every surgery to treat the same condition goes exactly the same way every time the FDA declined to be interviewed for this story, but plans to make changes to the process over the next few months. The is pushing back on manufacturers basing any new device on one that's more than ten years old and regulators say they'll do a better job of watching. How devices do once they're on the market rather than relying on patients to report problems? Michael Metheny, a professor who tracks medical devices at Vanderbilt University approves of the FDA's incremental approach and calls thoughtful, he says he wouldn't want the changes to spark hysteria over device failures. It would really be unfortunate. If patients wouldn't consider any medical devices at all to be used in their bodies. But I do think being aware that there's nothing without risk is also important McCain notes, though that in some ways the risks are more profound than with medication if the FDA recalls pills. A patient can at least stop taking them immediately with a device, they're sort of stuck with it at least for a while. And that's if a surgeon can even safely remove it for NPR news. I'm Blake farmer in Nashville. The story is part of a reporting partnership between NPR Nashville, public radio and Kaiser health news. Support for this podcast and the following message. Come from Comcast business having the nation's largest gig speed network was just the start. Now, they're providing gig fueled apps and solutions that exceed expectations and help businesses perform Comcast business beyond fast.

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