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

 

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")

1 intensify   

vt.加强；变强；加剧

参考例句：

• We must intensify our educational work among our own troops.我们必须加强自己部队的教育工作。
• They were ordered to intensify their patrols to protect our air space.他们奉命加强巡逻，保卫我国的领空。

2 scrutiny   

n.详细检查，仔细观察

参考例句：

• His work looks all right,but it will not bear scrutiny.他的工作似乎很好，但是经不起仔细检查。
• Few wives in their forties can weather such a scrutiny.很少年过四十的妻子经得起这么仔细的观察。

3 implants   

n.（植入身体中的）移植物( implant的名词复数 )

参考例句：

• Hormone implants are used as growth boosters. 激素植入物被用作生长辅助剂。 来自《简明英汉词典》
• Perhaps the most far-reaching project is an initiative called Living Implants From Engineering (LIFE). 也许最具深远意义的项目，是刚刚启动的建造活体移植工程 (LIFE)。 来自英汉非文学 - 生命科学 - 医学的第四次革命

4 cosmetic   

n.化妆品；adj.化妆用的；装门面的；装饰性的

参考例句：

• These changes are purely cosmetic.这些改变纯粹是装饰门面。
• Laughter is the best cosmetic,so grin and wear it!微笑是最好的化妆品，所以请尽情微笑吧！

5 byline   

n.署名；v.署名

参考例句：

• His byline was absent as well.他的署名也不见了。
• We wish to thank the author of this article which carries no byline.我们要感谢这篇文章的那位没有署名的作者。

6 surgically   

adv. 外科手术上, 外科手术一般地

参考例句：

• Unsightly moles can be removed surgically. 不雅观的痣可以手术去除。
• To bypass this impediment an almost mature egg cell is removed surgically. 为了克服这一障碍，通过手术，取出一个差不多成熟的卵细胞。

7 spinal   

adj.针的，尖刺的，尖刺状突起的；adj.脊骨的，脊髓的

参考例句：

• After three days in Japan,the spinal column becomes extraordinarily flexible.在日本三天，就已经使脊椎骨变得富有弹性了。
• Your spinal column is made up of 24 movable vertebrae.你的脊柱由24个活动的脊椎骨构成。

8 mesh   

n.网孔，网丝，陷阱；vt.以网捕捉，啮合，匹配；vi.适合； [计算机]网络

参考例句：

• Their characters just don't mesh.他们的性格就是合不来。
• This is the net having half inch mesh.这是有半英寸网眼的网。

9 strap   

n.皮带，带子；v.用带扣住，束牢；用绷带包扎

参考例句：

• She held onto a strap to steady herself.她抓住拉手吊带以便站稳。
• The nurse will strap up your wound.护士会绑扎你的伤口。

10 embedded   

a.扎牢的

参考例句：

• an operation to remove glass that was embedded in his leg 取出扎入他腿部玻璃的手术
• He has embedded his name in the minds of millions of people. 他的名字铭刻在数百万人民心中。

11 chronic   

adj.(疾病)长期未愈的，慢性的；极坏的

参考例句：

• Famine differs from chronic malnutrition.饥荒不同于慢性营养不良。
• Chronic poisoning may lead to death from inanition.慢性中毒也可能由虚弱导致死亡。

12 high-tech   

adj.高科技的

参考例句：

• The economy is in the upswing which makes high-tech services in more demand too.经济在蓬勃发展，这就使对高科技服务的需求量也在加大。
• The quest of a cure for disease with high-tech has never ceased. 人们希望运用高科技治疗疾病的追求从未停止过。

13 inert   

adj.无活动能力的，惰性的；迟钝的

参考例句：

• Inert gas studies are providing valuable information about other planets,too.对惰性气体的研究，也提供了有关其它行星的有价值的资料。
• Elemental nitrogen is a very unreactive and inert material.元素氮是一个十分不活跃的惰性物质。

14 hips   

abbr.high impact polystyrene 高冲击强度聚苯乙烯，耐冲性聚苯乙烯n.臀部( hip的名词复数 )；[建筑学]屋脊；臀围（尺寸）；臀部…的

参考例句：

• She stood with her hands on her hips. 她双手叉腰站着。
• They wiggled their hips to the sound of pop music. 他们随着流行音乐的声音摇晃着臀部。 来自《简明英汉词典》

15 forth   

adv.向前；向外，往外

参考例句：

• The wind moved the trees gently back and forth.风吹得树轻轻地来回摇晃。
• He gave forth a series of works in rapid succession.他很快连续发表了一系列的作品。

16 scathing   

adj.（言词、文章）严厉的，尖刻的；不留情的adv.严厉地，尖刻地v.伤害，损害（尤指使之枯萎）( scathe的现在分词)

参考例句：

• a scathing attack on the new management 针对新的管理层的猛烈抨击
• Her speech was a scathing indictment of the government's record on crime. 她的演讲强烈指责了政府在犯罪问题上的表现。 来自《简明英汉词典》

17 defective   

adj.有毛病的，有问题的，有瑕疵的

参考例句：

• The firm had received bad publicity over a defective product. 该公司因为一件次品而受到媒体攻击。
• If the goods prove defective, the customer has the right to compensation. 如果货品证明有缺陷， 顾客有权索赔。

18 ethical   

adj.伦理的，道德的，合乎道德的

参考例句：

• It is necessary to get the youth to have a high ethical concept.必须使青年具有高度的道德观念。
• It was a debate which aroused fervent ethical arguments.那是一场引发强烈的伦理道德争论的辩论。

19 incremental   

adj.增加的

参考例句：

• For logic devices, the incremental current gain is very important. 对于逻辑器件来说，提高电流增益是非常重要的。 来自辞典例句
• By using an incremental approach, the problems involving material or geometric nonlinearity have been solved. 借应用一种增量方法，已经解决了包括材料的或几何的非线性问题。 来自辞典例句

20 partnership   

n.合作关系，伙伴关系

参考例句：

• The company has gone into partnership with Swiss Bank Corporation.这家公司已经和瑞士银行公司建立合作关系。
• Martin has taken him into general partnership in his company.马丁已让他成为公司的普通合伙人。