| 加强植入医疗器械的监管 |
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| 引用本文： | 邵安裕. 加强植入医疗器械的监管[J]. 中国医疗器械杂志, 2003, 27(4): 284-286 |
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| 作者姓名： | 邵安裕 |
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| 作者单位： | 上海市药品监督管理局黄浦分局,上海,200002 |
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| 摘 要： | 植入医疗器械是一种高风险的产品．为保障人民的身体健康和生命安全．本文探讨从植入医疗器械进货源头实施控制．强化对仓储保管、临床使用和手术后各环节的跟踪，加强对植入医疗器械的监督管理．最终保证医疗器械在人体使用的安全有效。
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| 关 键 词： | 植入医疗器械 监督管理 采购 保管 使用 不良事件处理 |
| 文章编号： | 1671-7104(2003)04-0284-02 |
| 修稿时间： | 2002-11-22 |
Strengthen the Supervision of Implantable Medical Devices |
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| SHAO An-yuShanghai Municipal Drug Administration,Huangpu Branch. Strengthen the Supervision of Implantable Medical Devices[J]. Chinese journal of medical instrumentation, 2003, 27(4): 284-286 |
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| Authors: | SHAO An-yuShanghai Municipal Drug Administration Huangpu Branch |
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| Abstract: | Medical implantable devices are a kind of products with a high risk, In order to ensure their clinical safety andeffectiveness, this paper discusses how to strengthen the supervision and regulation including supply-source control, a good warehouse keeping and the post-operation folow-up. |
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| Keywords: | implantable medical device circulate use supervision and administration |
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