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.
出处
《中国医疗器械杂志》
CAS
2008年第1期47-49,共3页
Chinese Journal of Medical Instrumentation
关键词
医疗器械不良事件
监测
医务工作者
意向
需求
medical device adverse event（MDAE）, monitoring, medical personnels, intention, need
