中国医疗设备2024，Vol.39Issue(7)：101-106,6.DOI:10.3969/j.issn.1674-1633.2024.07.017
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
摘要
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分类
医药卫生引用本文复制引用
郑丽纯,蒋永兆,操练武,吴凤祥,周燕..三级医疗机构Ⅲ类医疗器械使用质量安全风险评估研究[J].中国医疗设备,2024,39(7):101-106,6.基金项目
江苏省重点研发计划社会发展面上项目(BE2022670) （BE2022670）
江苏省医院协会医院管理创新研究课题(JSYGY-3-2023-344) （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). （022M502）
