Objective:To analyzes the current situation and issues faced by medical device manufacturers for epidemic prevention and control in Hunan province and to put forward suggestions for their supervision.Methods:The 2022 special inspection report on epidemic prevention and control was reviewed.Special inspections were conducted on 193 manufacturers of medical devices used for epidemic prevention and control.The main problems found during on-site inspections were analyzed,and regulatory suggestions were proposed.Results:The defects were mainly concentrated in production management(20.24%),plant and facilities(13.14%),quality control(10.65%),organization and personnel(7.80%),document management(6.03%),and equipment(3.19%).Major risks included inadequate enterprise management capacity,insufficient inspection capacities and overproduction.Conclusion:Based on the on-site inspection of medical device manufacturers for epidemic prevention and control in Hunan province,it is recommended to enhance supervision through three main approaches:strengthening the training of full-time inspectors,supporting the skills training of key personnel in enterprises,and improving the quality management and focus of the inspection process to ensure the quality and safety of epidemic prevention medical devices.
关键词
疫情防控/专项检查/医疗器械/生产企业/检查情况
Key words
epidemic prevention and control/special inspection/medical devices/manufacturers/inspection situation
维普
万方数据