三级医疗机构Ⅲ类医疗器械使用质量安全风险评估研究  

Study on Quality and Safety Risk Assessment of ClassⅢMedical Device Usage in Tertiary Medical Institutions

作　　者：郑丽纯[1,2] 蒋永兆 操练武 吴凤祥 周燕 ZHENG Lichun;JIANG Yongzhao;CAO Lianwu;WU Fengxiang;ZHOU Yan(Nanjing Stomatological Hospital,Affiliated Hospital of Medical School,Nanjing University,Nanjing Jiangsu 210008,China;Institute of Stomatology,Nanjing University,Nanjing Jiangsu 210008,China;Department of Medical Device Supervision,Nanjing Market Supervision Administration,Nanjing Jiangsu 210018,China)

机构地区：[1]南京大学医学院附属口腔医院/南京市口腔医院医疗设备科,江苏南京210008 [2]南京大学口腔医学研究所,江苏南京210008 [3]南京市市场监督管理局医疗器械监管处,江苏南京210018

出　　处：《中国医疗设备》2024年第7期101-106,共6页China Medical Devices

基　　金：江苏省重点研发计划社会发展面上项目(BE2022670);江苏省医院协会医院管理创新研究课题(JSYGY-3-2023-344);南京大学医学院附属口腔医院3456骨干人才资助项目(022M502)。

摘　　要：目的评估某市三级医疗机构的Ⅲ类医疗器械使用质量安全风险,建立Ⅲ类医疗器械风险评估长效机制,维护医患用械安全。方法某市市场监督管理局通过德尔菲专家咨询法设计调研问卷,确定评估标准并遴选成立专家库,在2020—2022年以“行政+专家”的方式,对全市三级医疗机构Ⅲ类医疗器械使用环节开展质量安全风险评估与分析。结果37家被评估的医疗机构平均得分为88.4分。扣分项目中,Ⅲ类医疗器械贮存环节涉及的医疗机构占比最高,共扣分84.5分,涉及风险机构33家,占比89.19%。所有子项目风险评估中,涉及风险机构占比最高的前3项为库房场所设施设备、质量管理制度、温湿度监测记录,其中两项属于贮存环节。结论“行政+专家”的医疗器械使用质量评估新模式有利于推动Ⅲ类医疗器械使用质量安全监管由末端控制向风险控制转变、由经验主导向技术主导转变,有效加强行政监督能力。Objective To evaluate the quality and safety risks of ClassⅢmedical device usage in a tertiary medical institution in a city,establish a long-term risk assessment mechanism for ClassⅢmedical device,and maintain the safety of medical equipment for doctors and patients.Methods A survey questionnaire was designed by the municipal market supervision administration through Delphi expert consultation method,the evaluation criteria was determined and an expert database was selected.Then a quality safety risk assessment and analysis on the usage of ClassⅢmedical devices in the city’s tertiary medical institutions was carried out in the way of“administrative+experts”from 2020 to 2022.Results The average score of 37 evaluated medical institutions was 88.4.Among the deduction items,the proportion of medical institutions involved in ClassⅢmedical device storage was the highest,with a total of 84.5 points,and 33 risk institutions were involved,accounting for 89.19%.In the risk assessment of all sub-projects,the top 3 items involving the highest proportion of risk institutions were warehouse facilities and equipment,quality management system,temperature and humidity monitoring records,two of which belonged to the storage link.Conclusion The new model of“administrative+expert”medical device usage quality assessment is conducive to promoting the quality and safety supervision of ClassⅢmedical devices use from end control to risk control,from experience-led to technology-led transformation,and effectively strengthen the ability of administrative supervision.

关 键 词：Ⅲ类医疗器械 使用环节 风险评估 行政监督 

分 类 号：R197.39[医药卫生—卫生事业管理]