娄底市医院医疗器械监管问题及对策研究

发布时间：2018-06-30 02:07

本文选题：委底市医院 + 医疗器械监管　；参考：《湖南大学》2013年硕士论文

【摘要】：医疗器械是一种特殊商品，直接关系着人民群众的身体健康和生命安全。近些年来因医疗器械产品质量问题引发的医疗不良事件逐年增加，给医疗器械监管带来新的挑战，医疗器械的安全和有效也成了全社会关注的焦点。由于我国医疗器械产业根基较浅，发展不充分，行业制度不够健全完善，医疗器械生产、经营等诸多环节存在隐患，政府部门要对其进行有力监管难度很大。再加上一些医疗器械生产企业唯利是图，制售假冒伪劣产品，且其制假手段不断翻新，形势更加隐蔽，更是加剧了市场秩序的紊乱，这些都给政府监管部门带来了困扰。面对医疗器械监管中出现的新问题和挑战，政府监管部门需要迎难而上，不断更新监管理念，创新工作方式，改进监管策略，提高监管水平。医院医疗器械监管工作是医疗器械监管工作的重要组成部分，在保障公众用械安全方面意义重大。如何正确认识并处理好娄底市医院医疗器械监管工作中存在的问题，具有重要的现实意义。本文从医疗器械产品的特殊性、医疗器械的定义、行业发展状况和监管状况入手，运用政府监管理论、政府责任理论和公共管理的相关理论，在阐述医疗器械监管的重要性和必要性的基础上，，研究和分析娄底市医疗器械行业发展状况和监管体制，对娄底市医院医疗器械监管过程中所存在的问题及其成因进行了分析，指出当前娄底市医院医疗器械监管过程中存在监管主体不明确、监管范畴不精准、监管内容不全面、监管制度不完善、监管落实不到位等问题，存在进货管理不规范、医疗器械内部管理不规范、不良事件监测工作力度不够、医疗器械维护工作不到位等现象，并从思想层面、监管法律法规层面、监管部门、监管队伍建设等方面对这些问题的成因进行了分析。同时，本文在对国内外医院医疗器械监管方面的做法进行分析的基础上，立足于娄底市医院医疗器械监管实际，提出了相关解决措施。本文主张明确监管主体，不断完善医疗器械监管法律体系；明确监管职能，正确处理各部门之间的关系，加强监管组织建设，提高监管人员的素质与能力。同时，创新监管方式，加强医院医疗器械监管信息化建设，实现医疗器械产品的全过程监管，并主张建设信用机制，避免涉械事件出现，以构建既可以促进医疗器械行业持续健康快速发展，又能保证产品质量安全的监管体系。
[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.
【学位授予单位】：湖南大学
【学位级别】：硕士
【学位授予年份】：2013
【分类号】：R197.32

【参考文献】