| 论“聚丙烯酰胺水凝胶事件”与医疗器械上市后的风险管理 |
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| 引用本文： | 沈沁.论“聚丙烯酰胺水凝胶事件”与医疗器械上市后的风险管理[J].抗感染药学,2010,7(4):297-299. |
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| 作者姓名： | 沈沁 |
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| 作者单位： | 苏州大学放射医学与公共卫生学院,江苏苏州215007 |
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| 摘 要： | 通过对＂聚丙烯酰胺水凝胶事件＂（PAHG）的回顾,结合医疗器械上市后风险管理的流程和要素,分析了该事件的风险管理和风险管理启示,探讨了我国医疗器械上市后风险管理的不足与发展方向。
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| 关 键 词： | 聚丙烯酰胺水凝胶事件 医疗器械 风险管理 不良事件 |
Discussion of Polyacrylamide Hydrogel(PAHG) Event and Risk Management for Post-marketing Medical Devices |
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| SHEN Qin.Discussion of Polyacrylamide Hydrogel(PAHG) Event and Risk Management for Post-marketing Medical Devices[J].Anti-infection Pharmacy,2010,7(4):297-299. |
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| Authors: | SHEN Qin |
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| Institution: | SHEN Qin＊ Radiation Medicine and Public Health School of Suzhou University,Suzhou Jiangsu 215007,China |
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| Abstract: | Through the review on the polyacrylamide hydrogel（PAHG） event and referring to the process and elements of risk management for post-marketing medical devices,the event with the guidance of risk management is analysed and the difficiency and improvment of risk management for post-marketing medical devices is discussed. |
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| Keywords: | PAHG medical devices risk management adverse event |
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