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

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.