本文選題：委底市醫(yī)院 + 醫(yī)療器械監(jiān)管　； 參考：《湖南大學》2013年碩士論文

【摘要】：醫(yī)療器械是一種特殊商品，直接關(guān)系著人民群眾的身體健康和生命安全。近些年來因醫(yī)療器械產(chǎn)品質(zhì)量問題引發(fā)的醫(yī)療不良事件逐年增加，給醫(yī)療器械監(jiān)管帶來新的挑戰(zhàn)，醫(yī)療器械的安全和有效也成了全社會關(guān)注的焦點。由于我國醫(yī)療器械產(chǎn)業(yè)根基較淺，發(fā)展不充分，行業(yè)制度不夠健全完善，醫(yī)療器械生產(chǎn)、經(jīng)營等諸多環(huán)節(jié)存在隱患，政府部門要對其進行有力監(jiān)管難度很大。再加上一些醫(yī)療器械生產(chǎn)企業(yè)唯利是圖，制售假冒偽劣產(chǎn)品，且其制假手段不斷翻新，形勢更加隱蔽，更是加劇了市場秩序的紊亂，這些都給政府監(jiān)管部門帶來了困擾。面對醫(yī)療器械監(jiān)管中出現(xiàn)的新問題和挑戰(zhàn)，政府監(jiān)管部門需要迎難而上，不斷更新監(jiān)管理念，創(chuàng)新工作方式，改進監(jiān)管策略，提高監(jiān)管水平。醫(yī)院醫(yī)療器械監(jiān)管工作是醫(yī)療器械監(jiān)管工作的重要組成部分，在保障公眾用械安全方面意義重大。如何正確認識并處理好婁底市醫(yī)院醫(yī)療器械監(jiān)管工作中存在的問題，具有重要的現(xiàn)實意義。 本文從醫(yī)療器械產(chǎn)品的特殊性、醫(yī)療器械的定義、行業(yè)發(fā)展狀況和監(jiān)管狀況入手，運用政府監(jiān)管理論、政府責任理論和公共管理的相關(guān)理論，在闡述醫(yī)療器械監(jiān)管的重要性和必要性的基礎(chǔ)上，，研究和分析婁底市醫(yī)療器械行業(yè)發(fā)展狀況和監(jiān)管體制，對婁底市醫(yī)院醫(yī)療器械監(jiān)管過程中所存在的問題及其成因進行了分析，指出當前婁底市醫(yī)院醫(yī)療器械監(jiān)管過程中存在監(jiān)管主體不明確、監(jiān)管范疇不精準、監(jiān)管內(nèi)容不全面、監(jiān)管制度不完善、監(jiān)管落實不到位等問題，存在進貨管理不規(guī)范、醫(yī)療器械內(nèi)部管理不規(guī)范、不良事件監(jiān)測工作力度不夠、醫(yī)療器械維護工作不到位等現(xiàn)象，并從思想層面、監(jiān)管法律法規(guī)層面、監(jiān)管部門、監(jiān)管隊伍建設(shè)等方面對這些問題的成因進行了分析。同時，本文在對國內(nèi)外醫(yī)院醫(yī)療器械監(jiān)管方面的做法進行分析的基礎(chǔ)上，立足于婁底市醫(yī)院醫(yī)療器械監(jiān)管實際，提出了相關(guān)解決措施。本文主張明確監(jiān)管主體，不斷完善醫(yī)療器械監(jiān)管法律體系；明確監(jiān)管職能，正確處理各部門之間的關(guān)系，加強監(jiān)管組織建設(shè)，提高監(jiān)管人員的素質(zhì)與能力。同時，創(chuàng)新監(jiān)管方式，加強醫(yī)院醫(yī)療器械監(jiān)管信息化建設(shè)，實現(xiàn)醫(yī)療器械產(chǎn)品的全過程監(jiān)管，并主張建設(shè)信用機制，避免涉械事件出現(xiàn)，以構(gòu)建既可以促進醫(yī)療器械行業(yè)持續(xù)健康快速發(fā)展，又能保證產(chǎn)品質(zhì)量安全的監(jiān)管體系。
[Abstract]:Medical device is a special commodity, directly related to the people's health and life safety. In recent years, the adverse medical events caused by the quality of medical devices have increased year by year, which brings new challenges to the supervision of medical devices. The safety and effectiveness of medical devices have also become the focus of attention of the whole society. It is very difficult for government departments to supervise medical device industry because of its shallow foundation, insufficient development, imperfect system, hidden trouble in the production and management of medical device and so on. In addition, some medical device manufacturing enterprises make and sell fake and shoddy products, and their means of making fake products are constantly renovated, the situation is more concealed, and the disorder of market order is aggravated, all of which bring trouble to the government supervision department. In the face of the new problems and challenges in the supervision of medical devices, the government regulatory authorities need to face the difficulties, constantly update the concept of supervision, innovate the way of work, improve the supervision strategy, and improve the level of supervision. The supervision of hospital medical devices is an important part of the supervision of medical devices, which is of great significance in ensuring the safety of public use of medical devices. How to correctly understand and deal with the problems existing in the supervision of medical devices in Loudi City is of great practical significance. This paper starts with the particularity of medical device products, the definition of medical device, the status of industry development and supervision, and applies the theory of government supervision, the theory of government responsibility and the theory of public administration. On the basis of expounding the importance and necessity of medical device supervision, this paper studies and analyzes the development situation and supervision system of medical device industry in Loudi city, and analyzes the existing problems and causes of medical device supervision in Loudi hospital. It is pointed out that in the process of supervision of medical devices in Loudi City, the main body of supervision is not clear, the scope of supervision is not precise, the content of supervision is not comprehensive, the supervision system is not perfect, and the supervision and implementation is not in place. The internal management of medical devices is not standardized, the monitoring of adverse events is not enough, the maintenance of medical devices is not in place and so on. Supervision team construction and other aspects of these problems are analyzed. At the same time, based on the analysis of the practice of medical device supervision in hospitals at home and abroad, based on the practice of medical device supervision in Loudi City, this paper puts forward some relevant measures. In this paper, the main body of supervision should be defined, the legal system of medical device supervision should be perfected, the function of supervision should be clarified, the relationship between various departments should be dealt with correctly, the construction of supervision organization should be strengthened, and the quality and ability of supervisors should be improved. At the same time, we should innovate the mode of supervision, strengthen the information construction of hospital medical device supervision, realize the whole process supervision of medical device products, and advocate the construction of credit mechanism to avoid the occurrence of armed incidents. It can not only promote the medical device industry to develop healthily and rapidly, but also guarantee the quality and safety of products.
【學位授予單位】：湖南大學
【學位級別】：碩士
【學位授予年份】：2013
【分類號】：R197.32

【參考文獻】

相關(guān)期刊論文 前10條

1 李立華;黃在明;周建國;;淺析基層醫(yī)療器械監(jiān)管問題與對策[J];長江大學學報(自然科學版);2011年04期

2 威廉·安德森,任東來;美國政府監(jiān)管程序的憲法基礎(chǔ)[J];南京大學學報(哲學.人文科學.社會科學版);2005年04期

3 張敏;;外來醫(yī)療器械監(jiān)管存在問題及管理對策[J];齊魯護理雜志;2011年33期

4 賀學龍;魯文榮;;醫(yī)療機構(gòu)醫(yī)療器械管理中存在的問題與建議[J];齊魯藥事;2006年03期

5 范斌新;張曉光;;醫(yī)療器械監(jiān)督管理計算機網(wǎng)絡(luò)系統(tǒng)的研究[J];齊魯藥事;2006年08期

6 董作軍;張宗利;鄭文華;;醫(yī)療器械使用環(huán)節(jié)監(jiān)管若干問題的研究[J];齊魯藥事;2007年04期

7 遲元勤;狄泉;;對醫(yī)療機構(gòu)使用醫(yī)療器械監(jiān)管的思考[J];齊魯藥事;2009年12期

8 徐瑞發(fā);;實施醫(yī)療器械監(jiān)管法規(guī)中苦干問題的探討[J];上海食品藥品監(jiān)管情報研究;2006年03期

9 朱清;喻洪流;;論我國醫(yī)療器械法律監(jiān)管現(xiàn)存的問題與機制完善[J];中國醫(yī)療前沿;2007年15期

10 屈寶剛;FDA的醫(yī)療器械管理[J];中國食品藥品監(jiān)管;2005年05期

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