[医疗器械不良事件监测评价及医务人员上报影响因素分析]
[Analysis on evaluation of medical device adverse events monitoring and some factors influencing MDAE's reporting by medical personnels].
作者信息
Liu Ai-Ping, Zhang Li-Ming, Yan Wei, Zhang Jing-Hang, Zhu Yan-Ping
机构信息
School of Public Health, Peking University, Beijing 100083.
出版信息
Zhongguo Yi Liao Qi Xie Za Zhi. 2008 Jan;32(1):47-9.
OBJECTIVE
To investigate the knowledge level related to medical device adverse events (MDAEs) among medical personnels, some factors influencing the reporting behavior and supervision and administrative strategies.
METHODS
Stratified sampling, cluster sampling and random sampling were adopted together and a questionnaire survey was conducted among 1897 subjects from 33 hospitals.
RESULTS
Medical personnels knew a very little about MDAEs and medical devices' post-market monitoring, but their attitudes towards its benefits were positive. Their intentions to report MDAEs were relatively strong, but there were still some barriers about it.
CONCLUSION
A monitoring system and a professional training model about MDAEs reporting should be established and improved in hospitals.
目的
调查医务人员对医疗器械不良事件的认知水平、影响报告行为的相关因素及监管策略。
方法
采用分层抽样、整群抽样和随机抽样相结合的方法，对33家医院的1897名对象进行问卷调查。
结果
医务人员对医疗器械不良事件及医疗器械上市后监测了解较少，但对其益处态度积极。他们报告医疗器械不良事件的意愿较强，但仍存在一些障碍。
结论
应在医院建立并完善医疗器械不良事件报告监测系统及专业培训模式。
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