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【单选题】

A prestigious medical group is concerned that most medical devices are cleared for sale without evidence that they are safe and effective. That should give everyone pause. A panel of experts assembled by the Institute of Medicine found the current regulatory approach is so defective that it called for it to be abandoned and replaced with a system better designed to protect the public’s health.
The committee found no reason to believe that any devices on the market are unsafe or ineffective; it said their use in clinical practice provides at least some level of confidence. But it threw up its hands and said it had no way to determine which, if any, devices might be risky because there is virtually no data to rely on.
That’s because only the highest-risk devices, such as implantable defibrillators (心脏除颤器) and replacement heart valves (瓣膜), undergo clinical trials in patients to show that they are safe and effective. Devices deemed only a "moderate risk" are cleared if the manufacturer can show that they are "substantially equivalent" to devices previously cleared. Those devices in turn may have been cleared because they were "substantially equivalent" to earlier devices that may no longer be in use.
Problems can arise when the devices are not all that similar or when none of the devices in a chain of supposed equivalents have ever been shown safe and effective. In recent years there have been reports of device failures and injuries.
The Food and Drug Administration was taken aback when the institute’s panel concluded, in complete agreement, that the current system could not be fixed because "substantial equivalence" is based on comparisons reaching back more than 35 years to devices that were never systematically assessed for safety or effectiveness.
The F. D. A. promptly rejected the notion of junking the system but said it would hold hearings on the report. The hearings will provide an opportunity to identify proposals—such as more rigorous observation of devices after they are on the market—that can be adopted comparatively quickly. The more radical notion of building a wholly new system needs more thorough airing but may be the way to go.
What does the Institute of Medicine suggest do

A.
Give patients more time to pause before operation.
B.
Assemble more experts to provide sound evidence.
C.
Design a better system to regulate medical devices.
D.
Found a medical group to protect the public’s health.
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举一反三

【单选题】在血液循环系统中,没有瓣膜的结构是( )

A.
静脉
B.
心室和动脉之间
C.
心房和心室之间
D.
动脉

【多选题】久心除颤器操作步骤?

A.
1.拉开除颤器外包装,按下电源键,开启除颤器;
B.
2.揭开患者衣物,揭开电极片上薄膜,按照示意图贴牢电极片,不要接触患者;
C.
3.根据语音提示确认是否进行除颤操作,需要按下正在闪烁的除颤键;
D.
4.根据语音提示开始心肺复苏。

【多选题】符合慢性心瓣膜病的描述有

A.
可引起瓣膜关闭不全
B.
可引起瓣膜狭窄
C.
狭窄和关闭不全常同时存在
D.
可累及二尖瓣
E.
可累及两个以上的瓣膜

【单选题】下列不符合慢性心瓣膜病的描述是

A.
病变不会同时累及两个瓣膜
B.
表现为心瓣膜狭窄或关闭不全
C.
二尖瓣最常受累,其次是主动脉瓣
D.
狭窄和关闭不全常同时存在

【多选题】有关瓣膜术后抗凝的问题,下列哪些说法正确()

A.
术后立即开始抗凝
B.
术后第2天开始拔出心包纵隔引流管后开始抗凝
C.
凝血酶原活动度维持在30%-40%
D.
换瓣术后每日口服华法林5mg,以防血栓形成
E.
根据凝血酶原活动度调整华法林的用量

【单选题】最常⻅的联合瓣膜病是

A.
⼆尖瓣狭窄合并⼆尖瓣关闭不全
B.
⼆尖瓣狭窄合并主动脉瓣关闭不全
C.
⼆尖瓣关闭不全合并主动脉瓣关闭不全
D.
⼆尖瓣狭窄合并主动脉瓣狭窄
E.
主动脉瓣狭窄合并三尖瓣关闭不全

【单选题】效率较低的心脏除颤器是()

A.
电容放电式直流除颤器
B.
延迟线式直流除颤器
C.
方波除颤器
D.
心脏复律器