本文選題：醫(yī)療器械 + 不良事件　； 參考：《蘇州大學》2012年碩士論文

【摘要】：目的：通過闡述分析醫(yī)療器械法規(guī)、監(jiān)管現(xiàn)狀和不良事件監(jiān)測工作狀況,揭示出我國在醫(yī)療器械不良事件監(jiān)測方面的法規(guī)和監(jiān)管的不足,并探究典型產(chǎn)品發(fā)生不良事件的原因,闡明當前我省開展醫(yī)療器械不良監(jiān)測工作的必要性和迫切性,并提出我國公共衛(wèi)生政策中對醫(yī)療器械上市后監(jiān)管的發(fā)展建議,加強政府對醫(yī)療器械的監(jiān)管管理,維護和保障公眾生命健康權益。 方法：通過查閱醫(yī)療器械不良事件監(jiān)測的相關文獻資料,收集國家、江蘇省、蘇州市各級藥監(jiān)部門及不良反應監(jiān)測中心的內(nèi)部工作文件、數(shù)據(jù),企業(yè)上報數(shù)據(jù)等,從醫(yī)療器械不良事件監(jiān)測的角度對我國醫(yī)療器械法規(guī)、監(jiān)管情況和監(jiān)測工作狀況現(xiàn)狀出發(fā)進行全面闡述分析,找出存在的不足和需要改進的方面,并探討如何在今后的工作進一步加強醫(yī)療器械不良事件監(jiān)測工作及產(chǎn)品上市后的監(jiān)管。 結(jié)果：近年來,國際上對醫(yī)療器械監(jiān)管的重點已經(jīng)呈現(xiàn)出從上市前審批向上市后監(jiān)管轉(zhuǎn)移的趨勢,而我國的不良事件工作開展起步較晚,且此項工作開展的實際效果比預期的要差,不良事件的報告數(shù)量與市場上的產(chǎn)品數(shù)量不匹配,質(zhì)量不高。在現(xiàn)階段,不管是由于產(chǎn)品本身質(zhì)量問題還是由產(chǎn)品設計、材料、生產(chǎn)、存儲、使用等因素引起的不良事件,均沒有被引起足夠的重視,不能為開展上市后醫(yī)療器械的再評價工作提供很好的基礎。我國醫(yī)療器械上市后法規(guī)體系不完善,監(jiān)管較薄弱,仍然存在許多問題,針對這樣的情況,具體提出六個方面的問題及發(fā)展建議,通過公共衛(wèi)生政策和法規(guī)手段進一步加強醫(yī)療器械不良事件監(jiān)測工作,對產(chǎn)品進行再評價,控制其風險,將監(jiān)管工作貫穿于醫(yī)療器械的研制、生產(chǎn)、銷售以及投入使用后的全過程,保障人民群眾用械安全有效。 結(jié)論：我國目前已初步建立了醫(yī)療器械不良事件的法規(guī)體系及監(jiān)測網(wǎng)絡,但我省的醫(yī)療器械監(jiān)測工作總體比較薄弱。目前,報告數(shù)量不多,報告質(zhì)量不高,是現(xiàn)實存在的兩大問題,這在很大程度上影響了對醫(yī)療器械風險的預防和控制。在已發(fā)生的不良事件中,既有產(chǎn)品質(zhì)量問題引起的,也有產(chǎn)品設計、材料、使用等因素造成的,監(jiān)管部門應引起重視,通過收集到的不良事件信息,運用公共衛(wèi)生政策和法規(guī)手段,認真開展上市后醫(yī)療器械產(chǎn)品風險的再評價,加強醫(yī)療器械上市后的監(jiān)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.
【學位授予單位】：蘇州大學
【學位級別】：碩士
【學位授予年份】：2012
【分類號】：R197.39

【參考文獻】

相關期刊論文 前10條

1 阮吉敏;中美醫(yī)療器械監(jiān)管的比較與分析[J];國際醫(yī)藥衛(wèi)生導報;2005年07期

2 劉衛(wèi)紅;周萬丹;;手術室外來器械的使用與管理現(xiàn)狀調(diào)查[J];中國感染控制雜志;2008年04期

3 趙秀玲;;高風險醫(yī)療器械的使用現(xiàn)狀及監(jiān)管對策[J];齊魯藥事;2008年05期

4 董謝平;王小華;沈錄峰;李振肅;;淺議骨科植入性醫(yī)療器械不良事件及其報告工作[J];臨床醫(yī)學工程;2008年09期

5 佟歡歡;;淺談醫(yī)療衛(wèi)生機構醫(yī)療器械不良事件監(jiān)測與管理[J];中國醫(yī)療設備;2009年01期

6 吳秀杰;;淺談醫(yī)療器械不良事件[J];中國醫(yī)療設備;2010年05期

7 徐海琴;曹鐵軍;殷朝慶;;如何避免醫(yī)療器械的不良事件[J];醫(yī)療衛(wèi)生裝備;2008年05期

8 吉利俠;;我院226例可疑醫(yī)療器械不良事件報告分析[J];醫(yī)療衛(wèi)生裝備;2012年06期

9 楊華;耿鳳英;金丹;;286例可疑醫(yī)療器械不良事件報告分析[J];中國藥物警戒;2007年03期

10 余永強;鄭玉建;;我國醫(yī)療器械不良事件監(jiān)測現(xiàn)狀研究[J];中國藥物警戒;2008年01期

，

本文編號：1758461