某大型综合医院2021—2023年医疗器械不良事件监测及报告分析  

Monitoring and Report Analysis of Adverse Events of Medical Devices in a Comprehensive Hospital from 2021 to 2023

作　　者：张哲[1] 李源[2] 杨栋[1] 霍永胜[1] 胡晓媛[2] ZHANG Zhe;LI Yuan;YANG Dong;HUO Yongsheng;HU Xiaoyuan(Department of Medical Engineering,The First Affiliated Hospital of Xinjiang Medical University,Urumqi Xinjiang 830054,China;Supply Department,The First Affiliated Hospital of Xinjiang Medical University,Urumqi Xinjiang 830054,China)

机构地区：[1]新疆医科大学第一附属医院医学工程科,新疆乌鲁木齐830054 [2]新疆医科大学第一附属医院供应科,新疆乌鲁木齐830054

出　　处：《中国医疗设备》2024年第10期104-110,共7页China Medical Devices

基　　金：新疆维吾尔自治区自然科学基金“杰出青年”项目(2022D01E074);国家卫生健康委医院管理研究所项目;新疆维吾尔自治区医院管理研究所开放课题(1103040409)。

摘　　要：目的通过分析某大型综合医院2021—2023年医疗器械不良事件(Medical Device Adverse Event,MDAE)监测情况,为医疗机构在医疗器械安全使用和不良事件监测工作中提供参考和借鉴。方法采用回顾性分析方法,统计分析该院1082例MDAE报告的报告年份、报告天数、审核结果和涉及的医疗器械名称、产地、管理类别、产品类别、产品分类等情况。结果该院近3年上报的MDAE总数和通过率逐年递增,平均报告天数呈下降趋势(P<0.001)。990例有效报告中,国产、Ⅱ类、无源医疗器械的不良事件例数高于进口、Ⅰ类和Ⅲ类、有源和体外诊断试剂(P<0.001);14-注输、护理和防护器械类的不良事件报告最多(P<0.05),以一次性器械断裂、变形或污染和输液泵、注射泵故障为主要不良表现;03-神经和心血管手术器械造成的严重伤害例数最多(P<0.001),主要为导丝和球囊的断裂、变形导致术中植入失败。结论开展采购、入库到临床使用的全流程追溯,将MDAE监测上报纳入科室目标考核,可加强临床科室和医疗器械管理人员联动,提升医疗机构MDAE监测效能。Objective To provide guidance in the safety use and adverse event monitoring of medical devices by analyzing the medical device adverse event(MDAE)reports of a comprehensive hospital from 2021 to 2023.Methods Retrospective analysis method was used to statistically analyze the reporting year,reporting days,audit results,medical device name,origin,management category,product category,product classification and correlation evaluation of 1082 cases of MDAE reports in the hospital.Results In the past three years,the total number of MDAE reported and the passing rate increased year by year,and the average reporting days showed a downward trend(P<0.001).Among the 990 valid reports,the numbers of MDAE reports in domestic,ClassⅡand passive medical devices were higher than those in imported,ClassⅠandⅢ,active medical devices and in vitro diagnostic reagents(P<0.05).The most MDAE reports were observed in 14-infusion,nursing,and protective equipment(P<0.001),the main MDAE symptoms included the breakage,deformation and contamination of disposable instruments,and the malfunction of infusion pumps and injection pumps.The highest number of serious injuries was 03-neurological and cardiovascular surgical instruments(P<0.001),mainly due to the breakage and deformation of the guide wire and balloon,resulting in intraoperative implantation failure.Conclusion By conducting full traceability from procurement,storage to clinical use,and adding MDAE reports into the departmental target assessment,the linkage between clinical departments and medical device management can be strengthened,thereby enhanced the effectiveness of MDAE monitoring efficiency in medical institutions.

关 键 词：医疗器械 不良事件 严重伤害 监测 全流程追溯 医疗器械故障 

分 类 号：R197.3[医药卫生—卫生事业管理]