--Cao Desen, Wu Hao: Quality management of clinical application of medical devices, Chinese Journal of Hospital Management, 2007 (8)
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2, the development of modern science and technology will be the development of clinical medicine has pushed to a new era of high technology, high-tech penetration into the study of pathology, clinical diagnosis, Interventional therapy, endophyte materials and functions, organ transplantation until the latest technology DNA gene therapy in various fields, the development of hospitals need first-class personnel, first-class technology and first-class modern equipment and instruments, so the development and improvement of the hospital's clinical and equipment management department are closely related. Equipment management department must understand the operation condition of the existing equipment in the hospital, as well as the analysis of economic and social benefits, such as the purchase period of equipment, depreciation, operation status, maintenance, maintenance schedule and maintenance costs, etc., to do a good job. Equipment management department must be in-depth clinical departments, departments, carefully research clinical development dynamics and demand. Through various channels to collect new technologies, new equipment, new devices, new supplies of information, receive and major equipment functions and performance, including diagnostic equipment, treatment equipment, inspection equipment and medical equipment and other equipment, such as the technical content and advanced degree and the main technical indicators.
--Cao Anzhi, Jiang Hongbing, Shu Huiyu, Liu Feng, Shen Shuqiu: medical device quality management system and suppliers and the development of modern hospitals in relation to the medical equipment, medical equipment, 2004 (06)
3, high-risk medical devices are implanted in the human body or used to support, maintain life or have a potentially dangerous medical device products, its The quality of medical devices is directly related to the patient's life.
--Zheng Fuyou, Jin Min: Quality Management of High-Risk Medical Devices and Countermeasures, China Pharmaceutical Affairs, 2006(1)
4, Quality Management and Corresponding General Aspects for Medical Devices (QM&C), 2006(1)
4, Quality Management and Corresponding General Aspects for Medical Devices, 2006(1)
5. Quality Management and Corresponding General Aspects for Medical Devices), referred to as ISO/TC210. The secretariat of this technical committee is located in AAMI (American Association for the Advancement of Medical Instrumentation).
--Chen Yuhong: Quality Management and General Aspects for Medical Devices, China Medical Devices Information, 1997 (6)
5, China's medical device industry in the near-zero basis, after more than 30 years of hard work, has now established a more complete scientific research and development, Industrial production and quality management system, the medical device industry has become China's high-tech, high-tech field of promising force.
--Pan Guangcheng: Medical Device Market Outlook, China Medical Device Information, 1997 (2)
6, medical engineering section after 20 years of development, its function from the initial equipment and equipment procurement, maintenance, development of modern medical equipment information management, technical management, quality management, Economic management and standardization of standards management; preventive testing and maintenance of medical instruments and equipment; planning and management of the construction of modern hospital medical facilities system, the combination of science and technology and medical development of novel and practical intelligent medical instruments and equipment, deepening and expanding the connotation of the development of the discipline. Clinical medical engineering discipline construction guiding ideology has been formed: that is, "based on medical equipment protection, equipment safety and quality management as the center, academic research-oriented. Promote the overall development of the discipline."
--Species Yinbao, Tang Chao: modern medical device management urgently need to solve several problems, "China Medical Equipment" 2005 (11)
7, according to the survey, medical institutions in the procurement of medical equipment, storage, use and so on, there are more problems. For example: the quality management system of medical devices is not perfect; some medical institutions do not have corresponding quality management organization of medical devices or do not have quality management personnel, and there is not enough training for the technicians who use medical devices; the legal qualification of the supplier enterprises is not strict; the storage and maintenance of the corresponding norms are not clear or operational; the monitoring and reporting system of adverse events of medical devices, and the reporting and emergency disposal mechanism of the major safety accidents are not sound. Reporting and emergency response mechanism is not sound, etc.
--Guo Cangtian, Improvement of the supervision of the use of medical devices, Practical New Medicine 2007 (12)
8, from the characteristics of the medical device enterprises, to follow the content of laws and regulations to improve the business performance of the enterprise as a guide, from prioritizing the education of decision-making level, zero-defect management, the implementation of the "5S" activities, GMP standardization, etc., to establish an effective quality management system.
--Gao Linlin: medical device companies how to establish an effective quality management system, "Science and Technology Information: Academic Edition" 2006 (2)
9, biological evaluation is part of the quality/risk management system of medical devices, is the process of analyzing and evaluating biological risks. First of all, its conclusion is based on the analysis and assessment of data from previous clinical applications, clinical evaluation of the device, biological experimental testing, etc., and the results of the trade-off between benefits and risks.
--Zhuang Fei, Ding Biao: Biological Evaluation in Medical Device Risk Management System, Chinese Journal of Medical Devices, 2007(4)
10, medical device cleaning is an important part of the work of hospital disinfection and supply centers, and an important part of the management of the process of medical devices before sterilization. Whether the cleaning of medical equipment to meet the clean requirements, to achieve the clean degree of the basis for what, how to judge the medical equipment...
--WANG Suzhen, WANG Xin, CHEN Wen, MIAO Xinxia, SHEN Liping: Cleanliness monitoring and quality management of medical device cleaning.