美国国家公共电台 NPR FDA Tightening Regulatory Requirements For Some Medical Devices

（单词翻译）

STEVE INSKEEP, HOST:

The Food and Drug Administration is being forced to intensify¹ scrutiny² of medical implants³. Now, when you hear the word implants, it's easy to think of cosmetic⁴ surgery, but the word here includes a growing number of potentially life-saving devices that doctors place inside their patients. The problem is many of the devices have been breaking down.

Blake Farmer of member station WPLN in Nashville reports on the effort to address that.

BLAKE FARMER, BYLINE⁵: There's no doubt that surgically⁶ implanted devices improve lives. Drug pumps, nerve stimulators, spinal⁷ rods - but the devices can also do serious damage like they have to Mechel Keel.

MECHEL KEEL: It ruined my life. Yes, it did. I'm sitting here with tears.

FARMER: Keel had problems with a leaky bladder, so a surgeon stitched a flexible mesh⁸ strap⁹ inside her pelvis. But the strap hardened and started cutting her insides. The pain kept her from returning to her job in Michigan as a hairdresser. Removing all the bits and pieces embedded¹⁰ in the scar tissue has required multiple surgeries and resulted in chronic¹¹ infections.

Keel can see why her doctor thought the high-tech¹² mesh would help. But she also now feels like she was a guinea pig.

KEEL: We were the testers. There was no animal testing done. We were the animals.

FARMER: For devices in which a failure could obviously be life-threatening, regulators have required some sort of human testing. But medical author Jeanne Lenzer says the FDA now acknowledges that even some seemingly inert¹³ devices have caused major problems.

JEANNE LENZER: So we have things like metal-on-metal hips¹⁴, which, outside the human body, seem to function just fine. They put them in little machines. They rack them back and forth¹⁵. They don't break. They put them inside people, and something very different happens.

FARMER: Lenzer just wrote a scathing¹⁶ 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 510(k). It allows manufacturers to bypass many requirements by showing their product is very similar to something already in use.

LENZER: You just say your device is like an old device, and the old device was never tested nor was your device.

FARMER: In practice, sometimes the basis for a whole family tree of devices turns out to be defective¹⁷. Pelvic mesh is 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 AdvaMed speaks for industry giants like Stryker, Johnson & Johnson and Medtronic.

SCOTT WHITAKER: Testing should be as complete and as thorough and as ethical¹⁸ and as appropriate as possible. But it doesn't all fit the same and can't all fit the same standard. Not every surgery to treat the same condition goes exactly the same way every time.

FARMER: The FDA declined to be interviewed for this story but plans to make changes to the process over the next few months. The agency is pushing back on manufacturers basing any new device on one that's more than 10 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 Matheny, a professor who tracks medical devices at Vanderbilt University, approves of the FDA's incremental¹⁹ approach and calls it thoughtful. He says he wouldn't want the changes to spark hysteria over device failures.

MICHAEL MATHENY: 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 is nothing without risk is also important.

MATHENY: Matheny 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.

(SOUNDBITE OF ERIC LAU'S "STAR TREKKING")

INSKEEP: This story is part of a reporting partnership²⁰ between NPR, Nashville Public Radio and Kaiser Health News.

(SOUNDBITE OF ERIC LAU'S "STAR TREKKING")