1. In the design and production process of medical devices, due to technical conditions, cognitive level and technical limitations, there is a lack of research and verification before listing, which will inevitably lead to defects; At the same time, due to the performance degradation, fault damage, improper operation or misuse of the instrument in the application process, the clinical risk of instrument application is further increased, and medical accidents related to the instrument may occur. In order to reduce this risk, the state should strengthen the access management and post-marketing supervision of medical devices, and hospitals should strengthen the access management of devices, operators and medical engineering support personnel, and incorporate the application of medical devices into medical quality management, and build a quality management system covering medical device procurement, clinical use and medical engineering support, so as to ensure the safety of doctors and patients and promote the improvement of comprehensive benefits of hospitals.

-Cao Desen, Wu Hao: Quality Management of Clinical Application of Medical Devices, China Journal of Hospital Management, 2007 (8)

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2. The development of modern science and technology has pushed clinical medicine into a brand-new high-tech era. High-tech has penetrated into pathological research, clinical diagnosis, interventional therapy, plant materials and functions, organ transplantation and the latest technology, DNA gene therapy and other fields. The development of hospitals needs first-class talents, first-class technology, first-class modern equipment and instruments. Therefore, the clinical development and improvement of the hospital is closely related to the equipment management department. The equipment management department must know the running status of the existing equipment in the hospital, as well as the analysis of economic and social benefits, such as the purchase cycle, depreciation, running status, maintenance, maintenance progress and maintenance costs of the equipment, so as to be aware of it. The equipment management department must go deep into the clinical department and carefully investigate the clinical development trend and demand. It is necessary to collect information on new technologies, new equipment, new instruments and new consumables through various channels, and collect the functions and performance of main equipment, including the technical content, advanced degree and main technical indicators of diagnostic equipment, therapeutic equipment, inspection equipment and medical auxiliary equipment.

-Cao Anzhi, Jiang, Shu, Liu Feng, Shen: The Relationship between Medical Device Quality Management System and the Development of Suppliers and Modern Hospitals, Medical Devices, 2004(06)

3. High-risk medical devices are medical device products implanted in human body or used to support and maintain life or potentially dangerous to human body, and their quality is directly related to the life safety of patients.

-Zheng,: Status and Countermeasures of Quality Management of High-risk Medical Devices, chinese pharmaceutical affairs, 2006( 1)

4. Quality management of medical devices and related general aspects (ISO/TC2 10 for short). The secretariat of this technical committee is located in AAMI (American Association for the Advancement of Medical Devices).

—— Chen Yuhong: Introduction and General Requirements of Medical Device Quality Management Standardization Organization, China Medical Device Information 1997(6).

After more than 30 years of efforts, China's medical device industry has established a relatively complete system of scientific research and development, industrial production and quality management, and the medical device industry has become a new force with great development potential in China's high-tech and high-tech fields.

—— Pan Guangcheng: Market Prospect of Medical Devices, Information of Medical Devices in China, 1997(2)

6. After more than 20 years of development, the function of medical engineering has developed from the initial equipment procurement and maintenance to the information management, technical management, quality management, economic management and standardized management of modern medical equipment; Preventive testing and maintenance of medical instruments and equipment; The planning and management of modern hospital medical facilities system and the development of novel and practical intelligent medical instruments and equipment by combining science, engineering and medicine have deepened and expanded the connotation of discipline development. The guiding ideology of the discipline construction of clinical medical engineering has been formed, that is, "based on medical device support, centered on equipment safety and quality management, and guided by academic research." Promote the all-round development of the discipline. "

—— Tang Chao bancassurance: several problems to be solved urgently in the management of modern medical devices, China Medical Devices, 2005( 1 1).

7. The survey shows that there are many problems in the procurement, storage and use of medical devices in medical institutions. For example, the quality management system of medical devices is not perfect; Some medical institutions do not have corresponding medical device quality management institutions or are not equipped with quality management personnel, and there is not enough training for technicians who use medical devices; The legal qualification examination of suppliers is not strict; In terms of storage and maintenance, the corresponding specifications are not clear or operability is not strong; The monitoring and reporting system of medical device adverse events and the reporting and emergency handling mechanism of major safety accidents are not perfect.

—— Guo Cangtian, Improving the Supervision of the Use of Medical Devices and Applying New Medicine 2007( 12)

8. Based on the characteristics of medical device enterprises, an effective quality management system is established from the aspects of paying attention to decision-making level, zero defect management, implementing "5S" activities and GMP norms, etc., with the guidance of following laws and regulations and improving enterprise performance.

-Gao Linlin: How to Establish an Effective Quality Management System for Medical Device Enterprises, Science and Technology Information: Academic Edition, 2006(2)

9. Biological evaluation is a part of medical device quality/risk management system, and it is a process of analyzing and evaluating biological risks. First, its conclusion is the result of weighing the benefits and risks on the basis of analyzing and evaluating the data of early clinical application, clinical evaluation of instruments and biological experiment detection.

-Zhuang Fei, Ding Biao: Application of Biological Assessment in Medical Device Risk Management System, China Medical Device Journal, 2007(4)

10, medical device cleaning is an important part of the work of hospital disinfection supply center, and it is also an important link in the process management of medical devices before sterilization. Whether cleanliness is completely related to the safety of medical care management. Whether the cleaning of medical devices meets the cleanliness requirements, what is the basis for achieving cleanliness, and how to judge medical devices. ...

—— Wang Suzhen, Miao, Shen Liping: Cleanliness Monitoring and Cleaning Quality Management of Medical Devices, China Disinfection Journal, 2008(3)