365例电子输注泵不良事件报告分析  

Analysis of 365 Cases of Adverse Events Reported by Electronic Infusion Pump

作　　者：马丹华 聂生东[1] 卞蓉蓉[2] 李尧[2] MA Danhua;NIE Shengdong;BIAN Rongrong;LI Yao(School of Medical Equipment and Food,Shanghai University of Science and Technology,Shanghai 200093,China;Jiangsu Provincial Monitoring Center for Adverse Drug Reactions,Nanjing Jiangsu 210002,China)

机构地区：[1]上海理工大学医疗器械与食品学院,上海200093 [2]江苏省药品不良反应监测中心,江苏南京210002

出　　处：《中国医疗设备》2020年第4期109-112,共4页China Medical Devices

摘　　要：目的探讨电子输注泵不良事件发生特点及其可能原因,为临床合理用械提供参考。方法采用回顾性分析方法,对江苏省数据库中2016年1月1日至2018年8月31日收集到的365例电子输注泵不良事件进行统计分析。结果365例报告中以医疗机构上报为主(94.79%),以女性居多,年龄在21~30岁的占比最高,为28.49%。预期治疗与疾病作用以术后镇痛为主(79.18%),不良事件表现以部件故障(64.38%)为多见。结论发生不良事件后,临床医护人员应及时排除故障,保证患者安全用械。上市许可持有人应充分落实企业主体责任,重视不良反应监测工作,对产品全生命周期负责。Objective To provide reference for rational use in the clinic via investigating characteristics and possible causes of adverse events in electronic infusion pump.Methods Retrospective analysis method was used to statistically analyze 365 cases of adverse events of electronic infusion pump collected from Jiangsu database from January 1,2016 to August 31,2018.Results Among the 365 cases reported,the majority were reported by medical institutions(94.79%),and the majority were women,with the highest proportion of those aged between 21 and 30 years old(28.49%).The expected therapeutic and disease effects were mainly postoperative analgesia(79.18%),and the adverse events were mostly component faults(64.38%).Conclusion After the occurrence of adverse events,clinical medical staff should promptly remove the failure to ensure the safety of patients.The holder of the listing license shall fully implement the main responsibility of the enterprise,attach importance to the monitoring of adverse reactions and be responsible for the whole life cycle of the product.

关 键 词：电子输注泵 医疗器械不良事件 不良事件监测 

分 类 号：R47[医药卫生—护理学] R197.39[医药卫生—临床医学]