[医疗器械不良事件监测主体履行效能及保障机制研究]
[Research on the Efficacy of Fulfillment of Medical Device Adverse Event Monitoring Entities and Safeguard Mechanism].
作者信息
Ren Wenxia, Mao Yangdui, Luo Wenhua, Ding Jing, Wang Wen, Zhu Qing
机构信息
Zhejiang Pharmaceutical College, Ningbo, 315100.
Zhejiang Medical Devices Evaluation Center, Hangzhou, 311100.
出版信息
Zhongguo Yi Liao Qi Xie Za Zhi. 2018 Jan 30;42(1):58-61. doi: 10.3969/j.issn.1671-7104.2018.01.016.
OBJECTIVES
To solve the problem that medical device adverse event monitoring entities perform their duties inadequately, to provide reference for perfecting the post-market surveillance system.
METHODS
Through theoretical and empirical research, the paper explored the ways to improve the performance of monitoring the adverse events of medical devices.
RESULTS
The survey found that the number of adverse event monitoring reports was few and the quality of report was poor. The root causes included lack of motivation of monitoring entities, the imperfect monitoring system, and the monitoring capability failure, etc.
CONCLUSIONS
The methods such as strengthening the main body responsibility consciousness, establishing evaluation system and accountability system, building social work network, are beneficial to the adverse events monitoring.
目的
解决医疗器械不良事件监测主体履职不力的问题，为完善上市后监管体系提供参考。
方法
通过理论和实证研究，探讨提高医疗器械不良事件监测工作效能的途径。
结果
调查发现不良事件监测报告数量少、质量差。其根源包括监测主体动力不足、监测体系不完善、监测能力失效等。
结论
强化主体责任意识、建立评估体系和问责制度、构建社会工作网络等方法，有利于不良事件监测工作。
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