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| 我国医疗器械不良事件报告的影响因素探讨 | |
| 引用本文： | 张素敏. 我国医疗器械不良事件报告的影响因素探讨[J]. 中国药物警戒, 2008, 5(4): 205-207 |
| 作者姓名： | 张素敏 |
| 作者单位： | 国家食品药品监督管理局药品评价中心,北京,100045 |
| 摘 要： | 医疗器械不良事件报告是发现医疗器械安全性隐患和采取风险管理措施的前提。通过对我国医疗器械不良事件报告影响因素的初步探讨,旨在为促进我国医疗器械不良事件报告数量的提高与进一步增强医疗器械风险管理能力提供参考。 |
| 关 键 词： | 医疗器械不良事件 报告 影响因素 探讨 |
Discussing the Influence Factors on Reporting Medical Device Adverse Event in China |
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| ZHANG Su-minCenter for Drug Reevaluation,SFDA. Discussing the Influence Factors on Reporting Medical Device Adverse Event in China[J]. Chinese JOurnal of Pharmacovigilance, 2008, 5(4): 205-207 | |
| Authors: | ZHANG Su-minCenter for Drug Reevaluation SFDA |
| Affiliation: | ZHANG Su-min(Center for Drug Reevaluation,SFDA,Beijing 100045,China) |
| Abstract: | The reporting of medical device adverse event(MDAE) is the first step on the detection of medical device problems and taking risk management actions.The influence factors on reporting MDAE are discussed in this article to provide reference for the developments of MDAE numbers and risk management abilities in China. |
| Keywords: | medical device adverse event reporting influence factors discussion |
| 本文献已被 CNKI 维普 万方数据 等数据库收录！ | |