FDA批准携带一次性帽的十二指肠镜

2017-09-21 常路 环球医学

日前,美国食品和药物管理局(FDA)批准首个携带一次性使用远端帽的十二指肠镜,其能减少设备污染,降低传播致命抗生素耐药感染的威胁

日前,美国食品和药物管理局(FDA)批准首个携带一次性使用远端帽的十二指肠镜,其能减少设备污染,降低传播致命抗生素耐药感染的威胁

该新型十二指肠镜设计用于可视化上消化道,以诊断和治疗胆汁和胰管疾病。

十二指肠镜由于其许多小而难以到达的部件而难以清洁和消毒。医院由脏的十二指肠镜引起的感染疫情可追溯到2012年。FDA已经推动制造商制造更容易清洁的设备。

FDA表示,该新型十二指肠镜上的一次性远端帽将使其更容易去除污染。该设备还具有更简单的用户界面,改进人体工程学,图像质量更好。

FDA医疗器械和放射健康中心医疗器械评估办公室代理主任William Maisel表示,我们相信新的一次性远端帽是降低与这些医疗器械相关的未来感染风险的重要一步。提高十二指肠镜的安全性是FDA的首要任务,我们鼓励企业继续追求有助于降低患者风险的创新。

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    2018-02-20 bugit
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    2017-09-23 zhouqu_8
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    2017-09-22 changjiu

    学习了.谢谢

    0

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    2017-09-22 天涯183

    非常好的文章.学习了

    0

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