医疗器械不良事件监测的实践与思考  

Practice and Thought on the Monitoring of Medical Device Adverse Events

作　　者：时先锋[1] 汪雅琴[2] 谢舒[3] 董冲[4] 李玲[4] SHI Xianfeng;WANG Yaqin;XIE Shu;DONG Chong;LI Ling(General Office,Guangdong Maternal&Children Health Care Hospital,Guangzhou Guangdong 511442,China;Department of Reproductive Health&Infertility,Guangdong Maternal&Children Health Care Hospital,Guangzhou Guangdong 511442,China;Department of Human Resource,Guangdong Maternal&Children Health Care Hospital,Guangzhou Guangdong 511442,China;Department of Equipment,Guangdong Maternal&Children Health Care Hospital,Guangzhou Guangdong 511442,China)

机构地区：[1]广东省妇幼保健院院办,广东广州511442 [2]广东省妇幼保健院生殖健康与不孕症科,广东广州511442 [3]广东省妇幼保健院人事科,广东广州511442 [4]广东省妇幼保健院设备科,广东广州511442

出　　处：《中国医疗设备》2021年第6期120-123,共4页China Medical Devices

基　　金：广东省医学科研基金(A2011079)。

摘　　要：目的探讨如何有效控制医疗器械潜在使用风险,保障公众用械安全。方法对某医院2014年至2019年主动上报的医疗器械不良事件数量、质量进行统计描述和根本原因分析。结果近6年该院报告数均在50例/年以上,护理人员报告比例占78.89%,共涉及15类产品,前5类占比84.16%;不良事件报表填报质量有待提高。结论从营造安全文化氛围并提高信息上报质量,运用管理工具提升事件原因分析能力,强化监管部门职能三方面做好持续监测及反馈控制工作,提升医院风险管理水平。Objective To discusses how to effectively control the potential usage risks of medical devices and ensure the safety of the public.Methods The number and quality of medical device adverse events actively reported by a hospital from 2014 to 2019 were statistically described and the root causes were analyzed.Results In the recent 6 years,medical adverse events in the hospital were reported more than 50 cases/year,and the proportion of nursing staff reports accounted for 78.89%.A total of 15 categories of products were involved,and the top 5 categories accounted for 84.16%.The quality of the reporting of adverse events needs to be further improved.Conclusion To improve the level of hospital risk management,we should build a safety culture atmosphere and improve the quality of information reporting,use management tools to improve the ability of analyzing the causes of incidents,and strengthen the functions of supervisory departments to carry out continuous monitoring and feedback control.

关 键 词：医疗器械 不良事件监测 质量控制 风险管理 

分 类 号：R197.39[医药卫生—卫生事业管理]