江苏省医疗器械不良事件监测现状分析

发布时间：2018-04-16 10:18

本文选题：医疗器械 + 不良事件　；参考：《苏州大学》2012年硕士论文

【摘要】：目的：通过阐述分析医疗器械法规、监管现状和不良事件监测工作状况,揭示出我国在医疗器械不良事件监测方面的法规和监管的不足,并探究典型产品发生不良事件的原因,阐明当前我省开展医疗器械不良监测工作的必要性和迫切性,并提出我国公共卫生政策中对医疗器械上市后监管的发展建议,加强政府对医疗器械的监管管理,维护和保障公众生命健康权益。方法：通过查阅医疗器械不良事件监测的相关文献资料,收集国家、江苏省、苏州市各级药监部门及不良反应监测中心的内部工作文件、数据,企业上报数据等,从医疗器械不良事件监测的角度对我国医疗器械法规、监管情况和监测工作状况现状出发进行全面阐述分析,找出存在的不足和需要改进的方面,并探讨如何在今后的工作进一步加强医疗器械不良事件监测工作及产品上市后的监管。结果：近年来,国际上对医疗器械监管的重点已经呈现出从上市前审批向上市后监管转移的趋势,而我国的不良事件工作开展起步较晚,且此项工作开展的实际效果比预期的要差,不良事件的报告数量与市场上的产品数量不匹配,质量不高。在现阶段,不管是由于产品本身质量问题还是由产品设计、材料、生产、存储、使用等因素引起的不良事件,均没有被引起足够的重视,不能为开展上市后医疗器械的再评价工作提供很好的基础。我国医疗器械上市后法规体系不完善,监管较薄弱,仍然存在许多问题,针对这样的情况,具体提出六个方面的问题及发展建议,通过公共卫生政策和法规手段进一步加强医疗器械不良事件监测工作,对产品进行再评价,控制其风险,将监管工作贯穿于医疗器械的研制、生产、销售以及投入使用后的全过程,保障人民群众用械安全有效。结论：我国目前已初步建立了医疗器械不良事件的法规体系及监测网络,但我省的医疗器械监测工作总体比较薄弱。目前,报告数量不多,报告质量不高,是现实存在的两大问题,这在很大程度上影响了对医疗器械风险的预防和控制。在已发生的不良事件中,既有产品质量问题引起的,也有产品设计、材料、使用等因素造成的,监管部门应引起重视,通过收集到的不良事件信息,运用公共卫生政策和法规手段,认真开展上市后医疗器械产品风险的再评价,加强医疗器械上市后的监管。
[Abstract]:Objective: to analyze the regulation of medical devices, the current situation of supervision and the monitoring of adverse events, to reveal the deficiencies of the laws and regulations on the monitoring of adverse events of medical devices in China, and to explore the causes of adverse events in typical products.This paper expounds the necessity and urgency of carrying out medical device monitoring in our province at present, and puts forward some suggestions for the development of the supervision of medical devices after marketing in the public health policy of our country, so as to strengthen the supervision and management of medical devices by the government.Safeguarding and safeguarding the interests of the public's right to life and health.Methods: the internal working documents, data and data reported by enterprises were collected by consulting the relevant literature of adverse events monitoring of medical devices, and collecting the internal working documents, data, and other data reported by the national, Jiangsu and Suzhou drug surveillance departments and the adverse reaction monitoring centers at all levels.From the point of view of monitoring adverse events of medical devices, this paper makes a comprehensive analysis of the regulations, supervision and monitoring status of medical devices in China, and finds out the shortcomings and aspects that need to be improved.It also discusses how to further strengthen the monitoring of adverse events of medical devices and the supervision after the products go on the market in the future.Results: in recent years, the focus of international supervision on medical devices has shown a trend from pre-market approval to post-market supervision, while the work of adverse events in China started relatively late.The actual effect of this work is worse than expected, and the number of adverse events reports does not match with the number of products on the market, and the quality is not high.At this stage, neither the quality of the product itself nor the adverse events caused by such factors as product design, material, production, storage and use have not been given sufficient attention.It can not provide a good basis for the reevaluation of medical devices after marketing.There are still many problems with the imperfect legal system and weak supervision of medical devices after listing in our country. In view of this situation, this paper puts forward six specific problems and suggestions for development.By means of public health policies and laws and regulations, we should further strengthen the monitoring of adverse events of medical devices, re-evaluate the products, control their risks, and conduct supervision throughout the development and production of medical devices.Sales and put into use after the whole process, to ensure the safety and effectiveness of the people with equipment.Conclusion: the regulatory system and monitoring network for adverse events of medical devices have been preliminarily established in China, but the monitoring work of medical devices in our province is generally weak.At present, the quantity and quality of reports are not high, which are two problems in reality, which to a great extent affect the prevention and control of medical device risk.Among the adverse events that have occurred, there are not only product quality problems, but also factors such as product design, materials and use. The regulatory authorities should pay attention to the adverse events information collected.By means of public health policy and laws and regulations, the re-evaluation of the risk of medical device products after marketing should be carried out seriously, and the supervision of medical device after marketing should be strengthened.
【学位授予单位】：苏州大学
【学位级别】：硕士
【学位授予年份】：2012
【分类号】：R197.39

【参考文献】