机构改革背景下江西省基层医疗器械监管现状研究

Research on the Current Situation of Jiangxi Province’s Grassroots Medical Device Supervision Under the Background of Institutional Reform

目的:了解江西省机构改革后基层医疗器械监管体系现状,为改善新形势下医疗器械监管模式提供建议。方法:采用问卷调查及现场调研的方法,对2018年、2020年江西省117家市、区(县)级监管部门和11家市级检验机构的基本情况进行调查,调查内容包括机构改革前后科室变动情况、现有人员情况、医疗器械监管及执法情况等,并结合省药品监督管理局年度报告数据,进行补充比较。结果:不同地区机构改革的科室设置差别较大,科室平均人员数由(2.92±1.59)人变为(3.08±1.55)人。检验机构的比例分别为16.1%和59.7%。机构改革后监管体系人手不足的情况明显,有82.9%的监管部门和90.0%的检验机构认为现有人员数量不足,61.5%的部门认为专业性有弱化倾向。但机构改革后执法力度增加,表现在违法医疗器械查处案件数增加248%,没收违法所得和罚款金额分别增加598.93%和435.10%。结论:机构改革后,基层医疗器械监管更为规范,监管力度大幅提高。但监管体系仍需从人才队伍建设、基层医疗器械监管规范化建设等方面加以突破。

Objective:To investigate the status quo of the grassroots medical device regulatory system after the institutional reform of Jiangxi Province and to provide suggestions for improving the regulatory and inspection capabilities.Methods:Questionnaire survey and field investigation was used to investigate the basic situation of 117 regulatory departments and 11 municipal level inspection institutions in Jiangxi Province in 2018 and 2020.The survey content includes changes in departments,existing personnel,medical device supervision and law enforcement,etc.before and after institutional reform,and supplementary comparisons were made based on the annual report data of the Provincial Drug Administration.Results:The department adjustments of different institutions are significantly different.The average number of staff in the department changed from(2.92±1.59)to(3.08±1.55),and that in inspection institutions is 16.1%and 59.7%respectively.After the institutional reform,the supervision system is obviously understaffed,with 82.9%of the supervision departments and 90.0%of the inspection institutions believing that the existing personnel are insufficient,and 61.5%of the inspection institutions believing that the personnel are not professional enough.However,after the institutional reform,the law enforcement has increased,showing that the number of illegal equipment cases increased by 248%,the confiscation of illegal income and fines increased by 598.93%and 435.10%respectively.Conclusion:After the institutional reform,the supervision of grassroots medical devices has been more standardized,and the supervision has been greatly improved.However,the supervision system still needs to make breakthroughs in the construction of talent team and the standardization of grassroots medical device supervision.