泰州市醫(yī)療器械安全監(jiān)管的現(xiàn)狀與對策研究
發(fā)布時間：2018-11-21 10:33
【摘要】：醫(yī)療器械基本特性是安全和有效,事關(guān)社會公眾身體健康與生命安全,是國家食品藥品安全戰(zhàn)略的重要組成部分。近年來,隨著經(jīng)濟社會的快速發(fā)展和科技水平的持續(xù)突破,社會公眾對身體健康與生命安全的需求伴著醫(yī)學(xué)診療手段的豐富不斷增強。醫(yī)療器械直接服務(wù)于醫(yī)療衛(wèi)生體系,是公共健康保障最重要的基礎(chǔ)。早期診斷、手術(shù)用械、重癥監(jiān)測與日常護理,公眾健康對醫(yī)療器械質(zhì)量安全有效的依賴不斷加大。但由于我國醫(yī)療器械相關(guān)產(chǎn)業(yè)基礎(chǔ)弱、安全監(jiān)管起步較晚,改革時期監(jiān)管體制機制尚未理順,加之醫(yī)療器械本身的跨學(xué)科復(fù)雜性,監(jiān)管手段比較單一原始,監(jiān)管基礎(chǔ)相對薄弱,導(dǎo)致大部分臨床損害多由醫(yī)療器械造成,從危害廣泛的"奧美定"到全國性的臨床致殘致死,醫(yī)療器械安全事件頻發(fā)。醫(yī)療器械安全監(jiān)管形勢依然嚴(yán)峻。論文通過分析政府加強醫(yī)療器械安全監(jiān)管的必要性,引用公共選擇理論和政府監(jiān)管理論,運用文獻(xiàn)調(diào)研、調(diào)查研究、比較分析的方法,從泰州市醫(yī)療器械產(chǎn)業(yè)狀況及安全監(jiān)管歷史與現(xiàn)狀著手,結(jié)合體制改革期間泰州市醫(yī)療器械安全監(jiān)管的實際,進(jìn)行安全監(jiān)管需求與安全監(jiān)管供給的量化對比與定性分析,研究得出醫(yī)療器械安全監(jiān)管主要存在上市前監(jiān)管效率低下、上市后監(jiān)管能力不足、改革期間體制保障不力等六方面的問題和不足。研究者通過調(diào)查研究及自身從事醫(yī)療器械的認(rèn)知,透過問題表象分析出法規(guī)效力與系統(tǒng)化程度不夠、排斥第三方專業(yè)服務(wù)的官僚化傾向、監(jiān)管體制不穩(wěn)定導(dǎo)致"內(nèi)耗"等五類深層次問題。通過對比海南等省市的先進(jìn)經(jīng)驗,借鑒美國、歐盟等發(fā)達(dá)國家較為成熟的安全監(jiān)管模式,得出上市前與上市后監(jiān)管并重、合理分權(quán)適度引入第三方服務(wù)、保證監(jiān)管隊伍專業(yè)性等經(jīng)驗啟示。最后,論文從監(jiān)管手段、監(jiān)管能力及執(zhí)法力度三個維度入手,依據(jù)問題產(chǎn)生的原因,給合先進(jìn)地區(qū)的經(jīng)驗啟示,遵循"改革解決政府失靈"、"決策避免集團利益"、"監(jiān)管保障最廣大公眾利益"等理念,有針對性地提出包括"建立統(tǒng)一有力監(jiān)管體制、上市前引入第三方專業(yè)服務(wù)、采取信息化監(jiān)管措施、培育社會共治氛圍、激勵醫(yī)療機構(gòu)自律與能動、強化專業(yè)化配備、推進(jìn)兩法銜接"等在內(nèi)的十五項解決問題的對策與建議。由于泰州市醫(yī)療器械產(chǎn)業(yè)與監(jiān)管現(xiàn)狀在全省乃至全國都有一定的代表性,因此,針對泰州市醫(yī)療器械安全監(jiān)管的優(yōu)化路徑設(shè)計,對提高國內(nèi)其它地區(qū)醫(yī)療器械安全監(jiān)管水平有一定的普適性和借鑒意義。
[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.
【學(xué)位授予單位】：南京理工大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2017
【分類號】：F203
本文編號：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.
【學(xué)位授予單位】：南京理工大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2017
【分類號】：F203
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