广州市医疗器械经营企业质量管理规范现场检查情况分析

Analysis of on-site inspection of quality managment standard of medical device business enterprises in Guangzhou City

目的了解广州市医疗器械经营企业质量管理情况及影响因素。方法按照《医疗器械经营质量管理规范现场检查指导原则》,收集广州市2017年9月—2021年4月第三类医疗器械经营企业质量管理现场检查数据。结果共开展现场检查工作4979次,不符合规范的发生率为11.3%。市中心城区不符合规范的发生率高于市周边城区;近年来不符合规范的发生率呈降低趋势;申请新办者不符合规范的发生率低于申请变更者。共发现缺陷项目8165次,其中关键缺陷项1446次,一般缺陷项6719次;人员培训为缺陷次数最多的一般项,质量管理机构职责为缺陷次数最多的关键项。因子分析结果显示,企业经营质量与人员水平、运营管理、硬件设施三个因素相关。结论广州市医疗器械经营企业整体质量管理水平有待提高,政府应加大监管力度,企业应提升主体责任意识,保证公众医疗器械使用安全。

Objective To know the quality management situation and influencing factors of medical device business enterprises in Guangzhou City.Methods According to the"Guiding Principles for On-site Inspection of Medical Device Operation Quality Management Specifications",collecting the data of the on-site inspection of good supplying practice of the third class medical device business enterprises in Guangzhou City from September,2017 to April,2021.Results A total of 4979 on-site inspections were carried out,and the non-compliance regulation rate was 11.3%.The non-compliance regulation rate in the downtown area was higher than that in the surrounding area.In recent years,the rate of non conformity decreased.The non-compliance rate of new applicants was lower than that of change applicants.A total of 8165 defects were found,including 1446 critical items and 6719 general items.Training of personnel was the general item with the largest number of defects,while responsibility of quality management organization was the key item with the largest number of defects.Factor analysis results showed that the business quality of enterprises was related with the three factors:business operation and personnel level,operation management and hardware facilities.Conclusion The overall quality management level of medical device business enterprises in Guangzhou City needs to be improved.The government should strengthen supervision,and the enterprises should enhance subject responsibility consciousness to ensure the safety of the public using medical devices.