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 Class Ⅲ Medical Device Usage in Tertiary Medical Institutions
郑丽纯 1蒋永兆 2操练武 2吴凤祥 2周燕2
作者信息
- 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;南京大学口腔医学研究所,江苏 南京 210008
- 2. 南京市市场监督管理局 医疗器械监管处,江苏 南京 210018
- 折叠
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.
Abstract
Objective To evaluate the quality and safety risks of Class Ⅲ medical device usage in a tertiary medical institution in a city,establish a long-term risk assessment mechanism for Class Ⅲ medical 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 Class Ⅲ medical 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 Class Ⅲ medical 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 Class Ⅲ medical 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Key words
class Ⅲ medical devices/usage/risk assessment/administrative supervision引用本文复制引用
基金项目
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)
出版年
2024
国家科技期刊平台
NSTL
万方数据