医疗器械检测中心实验室信息管理系统

发布时间：2018-05-01 12:34

本文选题：医疗器械 + 检测　；参考：《吉林大学》2014年硕士论文

【摘要】：本论文依据《医疗器械监督管理条例》（国务院令第276号）、《国家药品监督管理局关于加强药品监督管理信息化建设的若干意见》国药管办[2000]3号、《国家医疗器械质量监督抽验管理规定（试行）》国食药监市[2006]463号的有关规定，贯彻落实"以监督为中心，监、帮、促相结合"的工作方针，充分应用现代信息科学技术和先进设备，实施科学管理，为医疗器械检测提供有力的保障。信息化的建设和由此而产生的先进监督管理方式，将大大提高办公效率，为廉洁执法、规范管理行为创造良好条件。加强医疗器械检测信息化建设，实现监督管理科学化、规范化，已经成为保证人民用械安全有效、促进医疗器械经济健康发展和逐步完善"依法监督、科学公正、廉洁高效、行为规范"的医疗器械管理体制的迫切需要。医疗器械产品关乎人民的生命健康。保证再用医疗器械的安全、有效性是各级监督部门工作的重中之重。而在日常的医疗器械检测工作中，传统的工作方式已经不适应现代化管理的要求。将信息化技术和传统的医疗器械检测技术有机的结合起来，为医疗器械的检测提供强有力的支持。应用现代化信息技术为医疗器械检测提供有力的帮助，真正的实现使医疗器械检测成为医疗器械监督的“抓手”，为医疗器械监督提供科学的、有力的法律保证。山西省医疗器械检测中心承担着全省再用医疗器械检测工作，医疗器械检测中心实验室检测具有专业性、标准性、唯一性、权威性，为山西省食品药品监督管理局医疗器械监督提供着强有力的法律支持和保证。医疗器械检测中心实验室信息管理系统的研发和使用是现代信息技术在医疗器械检测工作中的实际体现，由此而形成了现代信息化的管理模式。实现了监督管理科学化、规范化。并且在规范检测流程建立起一个紧密、协调、可靠、简单的管理机制，使工作人员责任明确，权限分明，具体事务落实到人，实现样品运行状态的全面追溯。查有所依，杜绝推脱、扯皮现象。消除数据的重复录入，保证正确、及时的反应。减少了由于检测人员的个人失误对检测结果准确性的影响，规范了检测人员的检测操作流程，从而使检测结果的科学性和准确性得到有力的保证。该软件的使用实现中心信息资源有效的流通、共享、提高工作效率、实现有效管理、职责分明、降低成本、管理中各环节可以有机结合，，无缝衔接使管理者全面掌握中心的工作动态。全面、及时、准确为医疗器械检测结果的科学公正提供客观依据和有力保证，为进一步防控在用医疗器械安全，切实加强信息化对行政监管的支撑力度，为信息化建设在医疗器械检测当中的实践提出了一个新的方向。
[Abstract]:This paper is based on the regulations on the Supervision and Administration of Medical Devices (decree No. 276 of the State Council, opinions of the State Drug Administration on strengthening the Informatization Construction of Drug Supervision and Administration), the State Drug Administration Office [2000] No. 3, and the quality of State Medical Devices Provisions on the Administration of Supervision and sampling (trial implementation) > the relevant provisions of the State Food and Drug Administration [2006] 463, We should carry out the working principle of "taking supervision as the center, supervision, help and promotion", make full use of modern information science and technology and advanced equipment, carry out scientific management, and provide a strong guarantee for medical device testing. The construction of information technology and the advanced supervision and management methods will greatly improve the efficiency of office work, and create good conditions for clean law enforcement and standardization of management behavior. Strengthening the construction of medical device testing information, realizing the scientific and standardized supervision and management, has become the guarantee of the safety and effectiveness of the people's armed apparatus, the promotion of the healthy development of the medical device economy and the gradual improvement of the "supervision according to law, scientific, fair, clean and efficient," The urgent need of the medical device management system based on the code of conduct. Medical device products are related to the life and health of the people. To ensure the safety and effectiveness of reusing medical devices is the top priority of supervision departments at all levels. But in the daily medical device inspection, the traditional work way has not been able to meet the modern management request. The combination of information technology and traditional medical device detection technology provides strong support for medical device detection. The application of modern information technology can provide powerful help for medical device testing, make medical device inspection become the "grip" of medical device supervision, and provide scientific and powerful legal guarantee for medical device supervision. Shanxi Medical device testing Center is responsible for the reusing of medical devices in the province. The laboratory testing of medical device testing center is professional, standard, unique and authoritative. It provides strong legal support and guarantee for the supervision of medical devices of Shanxi Food and Drug Administration. The research and development and use of laboratory information management system in medical device testing center is the actual embodiment of modern information technology in medical device testing work, which forms the modern information management mode. Scientific and standardized supervision and management has been realized. And a close, coordinated, reliable and simple management mechanism is established in the standardized testing process, which makes the staff members clear responsibility, clear authority, specific affairs to the people, to achieve a comprehensive traceability of the sample operation status. Check some basis, put an end to shedding, the phenomenon of bulldozing. Eliminate duplicate data entry and ensure correct and timely response. It reduces the influence of personal error on the accuracy of test results, and standardizes the testing operation flow, which ensures the scientific and accuracy of the test results. The use of the software realizes the effective circulation and sharing of the central information resources, improves the working efficiency, realizes the effective management, has clear responsibilities, reduces the cost, and the various links in the management can be combined organically. Seamless connection enables managers to fully grasp the work dynamics of the center. In an all-round, timely and accurate way to provide an objective basis and a strong guarantee for the scientific and impartial results of the testing of medical devices, and to strengthen the support of information technology for administrative supervision in order to further prevent and control the safety of medical devices in use, A new direction is put forward for the practice of information construction in medical device testing.
【学位授予单位】：吉林大学
【学位级别】：硕士
【学位授予年份】：2014
【分类号】：TP315

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