医务工作者报告医疗器械不良事件的影响因素  

Analysis on Evaluation of Medical Device Adverse Events Monitoring and Some Factors In uencing MDAE's Reporting by Medical Personnels

作　　者：刘爱萍[1] 张黎明[2] 闫炜[2] 张京航[2] 朱燕萍[1] 

机构地区：[1]北京大学医学部公共卫生学院,北京100083 [2]北京市药品不良反应监测中心,北京100024

出　　处：《中国医疗器械杂志》2008年第1期47-49,共3页Chinese Journal of Medical Instrumentation

摘　　要：目的了解不同医疗机构医务工作者对医疗器械不良事件及相关知识的认知程度,以及对医疗器械不良事件监测的评价,探讨影响报告医疗器械不良事件的因素及监管策略。方法采取分层整群随机抽样相结合的方法,对1897名医务工作者进行问卷调查。结果医务工作者对医疗器械不良事件及监测知识的了解程度较低,对医疗器械不良事件监测益处的评价持正向态度。报告医疗器械不良事件的意向较为强烈,但存在阻碍因素。结论应加强医务工作者的医疗器械不良事件培训,促使医疗机构建立和完善医疗器械不良事件监测体系,以增强医务工作者的认识,提高对不良事件的发现能力和报告能力。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.

关 键 词：医疗器械不良事件 监测 医务工作者 意向 需求 

分 类 号：C931.2[经济管理—管理学]