Study on Quality and Safety Risk Assessment of Class Ⅲ Medical Device Usage in Tertiary Medical Institutions
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.
class Ⅲ medical devicesusagerisk assessmentadministrative supervision
国家科技期刊平台
NSTL
万方数据
