泰州市医疗器械安全监管的现状与对策研究
发布时间：2018-11-21 10:33
【摘要】：医疗器械基本特性是安全和有效,事关社会公众身体健康与生命安全,是国家食品药品安全战略的重要组成部分。近年来,随着经济社会的快速发展和科技水平的持续突破,社会公众对身体健康与生命安全的需求伴着医学诊疗手段的丰富不断增强。医疗器械直接服务于医疗卫生体系,是公共健康保障最重要的基础。早期诊断、手术用械、重症监测与日常护理,公众健康对医疗器械质量安全有效的依赖不断加大。但由于我国医疗器械相关产业基础弱、安全监管起步较晚,改革时期监管体制机制尚未理顺,加之医疗器械本身的跨学科复杂性,监管手段比较单一原始,监管基础相对薄弱,导致大部分临床损害多由医疗器械造成,从危害广泛的"奥美定"到全国性的临床致残致死,医疗器械安全事件频发。医疗器械安全监管形势依然严峻。论文通过分析政府加强医疗器械安全监管的必要性,引用公共选择理论和政府监管理论,运用文献调研、调查研究、比较分析的方法,从泰州市医疗器械产业状况及安全监管历史与现状着手,结合体制改革期间泰州市医疗器械安全监管的实际,进行安全监管需求与安全监管供给的量化对比与定性分析,研究得出医疗器械安全监管主要存在上市前监管效率低下、上市后监管能力不足、改革期间体制保障不力等六方面的问题和不足。研究者通过调查研究及自身从事医疗器械的认知,透过问题表象分析出法规效力与系统化程度不够、排斥第三方专业服务的官僚化倾向、监管体制不稳定导致"内耗"等五类深层次问题。通过对比海南等省市的先进经验,借鉴美国、欧盟等发达国家较为成熟的安全监管模式,得出上市前与上市后监管并重、合理分权适度引入第三方服务、保证监管队伍专业性等经验启示。最后,论文从监管手段、监管能力及执法力度三个维度入手,依据问题产生的原因,给合先进地区的经验启示,遵循"改革解决政府失灵"、"决策避免集团利益"、"监管保障最广大公众利益"等理念,有针对性地提出包括"建立统一有力监管体制、上市前引入第三方专业服务、采取信息化监管措施、培育社会共治氛围、激励医疗机构自律与能动、强化专业化配备、推进两法衔接"等在内的十五项解决问题的对策与建议。由于泰州市医疗器械产业与监管现状在全省乃至全国都有一定的代表性,因此,针对泰州市医疗器械安全监管的优化路径设计,对提高国内其它地区医疗器械安全监管水平有一定的普适性和借鉴意义。
[Abstract]:The basic characteristic of medical device is safe and effective, which is related to the public health and life safety. It is an important part of the national food and drug safety strategy. In recent years, with the rapid development of economy and society and the continuous breakthrough of the level of science and technology, the public demand for physical health and life safety is increasing with the enrichment of medical diagnosis and treatment means. Medical devices directly serve the health care system, which is the most important foundation of public health protection. Early diagnosis, surgical instruments, intensive care and daily care, public health is increasingly dependent on the quality and safety of medical devices. However, because of the weak industrial foundation of medical devices in China, the late start of safety supervision, the unstraightened supervision system mechanism in the period of reform, and the interdisciplinary complexity of medical devices themselves, the means of supervision are relatively simple and primitive, and the regulatory basis is relatively weak. Most of the clinical injuries are caused by medical devices, ranging from omidine, which is harmful widely, to clinical disability and death, and frequent medical device safety incidents. Medical device safety supervision situation is still grim. By analyzing the necessity of strengthening the safety supervision of medical devices by the government, citing the theory of public choice and the theory of government supervision, using the methods of literature investigation, investigation and research, and comparative analysis, Starting from the situation of medical device industry and the history and present situation of safety supervision in Taizhou, combined with the actual situation of medical device safety supervision in Taizhou during the reform of the system, the quantitative comparison and qualitative analysis between the demand for safety supervision and the supply of safety supervision are carried out. It is concluded that there are six problems and deficiencies in the supervision of medical device safety, such as low efficiency before listing, insufficient supervision ability after listing, weak system guarantee during the reform period, and so on. Through investigation and research and their own cognition of medical devices, the researchers analyze through problem representation that the degree of effectiveness and systematization of laws and regulations is not enough, and they reject the bureaucratic tendency of professional services of third parties. The instability of supervision system leads to five kinds of deep problems, such as internal friction. By comparing the advanced experiences of Hainan and other provinces and cities, and drawing lessons from the more mature safety supervision models of the developed countries such as the United States and the European Union, the paper draws the conclusion that the supervision before and after listing should pay equal attention to the supervision, with reasonable decentralization and appropriate introduction of third-party services. Ensure supervision team professional and other experience enlightenment. Finally, the paper starts with the three dimensions of supervision means, supervision ability and law enforcement strength, according to the causes of the problems, gives the experience enlightenment of the advanced regions, follows "reform to solve the government failure", "decision-making to avoid group interests". The concept of "supervision to protect the interests of the broadest public" has been put forward in a targeted manner, including "establishing a unified and capable regulatory system, introducing professional services from third parties before going on the market, adopting information supervision measures, and fostering an atmosphere of common governance in society." The 15 countermeasures and suggestions to solve the problems, such as encouraging medical institutions to self-discipline and initiative, strengthening specialized equipment, and promoting the convergence of the two methods, etc. As the current situation of medical device industry and supervision in Taizhou City is representative in the whole province and even in the whole country, the optimized path design for the safety supervision of medical device in Taizhou City, It can improve the level of medical device safety supervision in other regions of China.
【学位授予单位】：南京理工大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：F203
本文编号：2346724
[Abstract]:The basic characteristic of medical device is safe and effective, which is related to the public health and life safety. It is an important part of the national food and drug safety strategy. In recent years, with the rapid development of economy and society and the continuous breakthrough of the level of science and technology, the public demand for physical health and life safety is increasing with the enrichment of medical diagnosis and treatment means. Medical devices directly serve the health care system, which is the most important foundation of public health protection. Early diagnosis, surgical instruments, intensive care and daily care, public health is increasingly dependent on the quality and safety of medical devices. However, because of the weak industrial foundation of medical devices in China, the late start of safety supervision, the unstraightened supervision system mechanism in the period of reform, and the interdisciplinary complexity of medical devices themselves, the means of supervision are relatively simple and primitive, and the regulatory basis is relatively weak. Most of the clinical injuries are caused by medical devices, ranging from omidine, which is harmful widely, to clinical disability and death, and frequent medical device safety incidents. Medical device safety supervision situation is still grim. By analyzing the necessity of strengthening the safety supervision of medical devices by the government, citing the theory of public choice and the theory of government supervision, using the methods of literature investigation, investigation and research, and comparative analysis, Starting from the situation of medical device industry and the history and present situation of safety supervision in Taizhou, combined with the actual situation of medical device safety supervision in Taizhou during the reform of the system, the quantitative comparison and qualitative analysis between the demand for safety supervision and the supply of safety supervision are carried out. It is concluded that there are six problems and deficiencies in the supervision of medical device safety, such as low efficiency before listing, insufficient supervision ability after listing, weak system guarantee during the reform period, and so on. Through investigation and research and their own cognition of medical devices, the researchers analyze through problem representation that the degree of effectiveness and systematization of laws and regulations is not enough, and they reject the bureaucratic tendency of professional services of third parties. The instability of supervision system leads to five kinds of deep problems, such as internal friction. By comparing the advanced experiences of Hainan and other provinces and cities, and drawing lessons from the more mature safety supervision models of the developed countries such as the United States and the European Union, the paper draws the conclusion that the supervision before and after listing should pay equal attention to the supervision, with reasonable decentralization and appropriate introduction of third-party services. Ensure supervision team professional and other experience enlightenment. Finally, the paper starts with the three dimensions of supervision means, supervision ability and law enforcement strength, according to the causes of the problems, gives the experience enlightenment of the advanced regions, follows "reform to solve the government failure", "decision-making to avoid group interests". The concept of "supervision to protect the interests of the broadest public" has been put forward in a targeted manner, including "establishing a unified and capable regulatory system, introducing professional services from third parties before going on the market, adopting information supervision measures, and fostering an atmosphere of common governance in society." The 15 countermeasures and suggestions to solve the problems, such as encouraging medical institutions to self-discipline and initiative, strengthening specialized equipment, and promoting the convergence of the two methods, etc. As the current situation of medical device industry and supervision in Taizhou City is representative in the whole province and even in the whole country, the optimized path design for the safety supervision of medical device in Taizhou City, It can improve the level of medical device safety supervision in other regions of China.
【学位授予单位】：南京理工大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：F203
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