PDCA循环在医疗器械不良事件个例报告表质量管理中的应用  

PDCA cycle in quality control of medical device adverse event report forms

作　　者：张博涵 蔡权周 杨燕妮 方雅宁 傅渊锋 ZHANG Bohan;CAI Quanzhou;YANG Yanni;FANG Yaning;FU Yuanfeng(Adverse Drug Reaction Monitoring Centre of Guangdong Province,Guangzhou 510000,China;Foshan Food&Drug Inspection Testing Center,Foshan 528000,China;Guangzhou Medicine Adverse Reaction Monitoring Center,Guangzhou 510000,China;Shenzhen Institute of Pharmacovigilance and Risk Management,Shenzhen 518000,China)

机构地区：[1]广东省药品不良反应监测中心,广东广州510000 [2]佛山市食品药品检验检测中心,广东佛山528000 [3]广州市药品不良反应监测中心,广东广州510000 [4]深圳市药物警戒和风险管理研究院,广东深圳518000

出　　处：《现代医院》2024年第5期707-710,共4页Modern Hospitals

基　　金：广东省药品监督管理局2022年科技创新项目(2022TDB49)。

摘　　要：目的评价PDCA循环在提高医疗器械不良事件报告表填写质量中的应用效果,为制定改善策略提供依据。方法在广东省范围内随机抽取实施PDCA活动前2022年1月1日—2022年3月31日的271份报告表作为实施前组,随机抽取实施PDCA活动后2023年1月1日—2023年3月31日的462份报告表作为实施后组,比较PDCA实施前后两组21个地市报告表质量评估平均得分变化,以评估效果。结果PDCA实施后组质量评估总体平均分高于实施前组,差异有统计学意义(P<0.05);改进主要体现在医疗器械情况、不良事件情况、使用情况的填写,差异有统计学意义(P<0.05)。结论PDCA循环能够有效提高医疗器械不良事件报告表的填写质量,对规范医疗器械不良事件监测工作和后续风险调查处置具有一定的意义。Objective This paper aims to evaluate the effectiveness of the Plan Do Check Act(PDCA)cycle in the quality improvement of medical device adverse event report forms to provide references for developing improvement strategies.Methods This study randomly selected 271 report forms from hospitals in Guangdong Province from January 1,2022,to March 31,2022 as the pre-implementation group.Another 462 report forms from January 1,2023,to March 31,2023 were randomly selected after implementing the PDCA cycle as the post-implementation group.The effect evaluation was concluded by comparing the average score on quality assessment of report forms between the two groups from 21 cities in Guangdong Province.Results The post-implementation group showed significantly higher overall average score on quality assessment as compared to the pre-implementation group(P<0.05).After the implementation,the form completions on medical devices,adverse events,and usage,were significantly improved(P<0.05).Conclusion The PDCA cycle can effectively improve the quality of medical device adverse event report forms,which is significant for standardizing the monitoring of medical device adverse events and subsequent investigation and resolution of risk.

关 键 词：PDCA 医疗器械不良事件 报告质量评估 

分 类 号：R197.323.4[医药卫生—卫生事业管理]