The speed of medical device technology update, the variety of products, the timeliness of demand, and the high security. The scientific management of medical devices is a complex, systematic project that manages the entire process of medical devices . Mainly involved in three aspects: First, technical management, mainly refers to the planning, purchase, installation, acceptance, use of medical equipment, as well as quality control, maintenance technology support, elimination and scrapping; second, economic management, mainly refers to Funding sources, budget analysis, cost calculation, benefit evaluation, etc. Third, the standardized management of information, quality and standards to achieve the overall goal of safe and effective medical devices. The scientific management of medical devices is an important carrier of advanced medical technology, and it is also a key way to establish a good hospital brand image, and it has increasingly become an important part of the hospital's core competitiveness.
The conflict between the widespread promotion of modern medical devices with new technologies and new materials in China and the relatively backward medical device management level and relatively lack of technical support has become increasingly acute, seriously hampering the hospital's level of diagnosis and treatment and modernization. . The conflict is mainly reflected in two aspects: first, the contradiction between the advancement of medical equipment and medical hygienic materials and the lag of medical device management mode; second, insufficient introduction of new medical devices, new technologies and new business development The contradiction between the slow progress and the unreasonable purchase and loss of medical equipment. The main issues are reflected in the following aspects.
1. The medical device management system is not perfect
Perfecting the system of medical device management is the primary prerequisite for the scientific management of medical devices.
From the national level, the current medical device management regulations are not perfect: the comprehensive content, system coordination, and scientific level of the system need to be improved. The independent legislation on the management of medical devices has caused overlapping duties and unclear authority. At the same time, the relevant supporting rules and regulations are lacking, the introduction is slow, and the standard construction is relatively lagging. As a result, the regulatory basis of medical device management in China is weak and the supervision is insufficient.
From the hospital level, the non-standardization of the medical device management system is mainly reflected in the lack of uniform and precise management norms and evaluation systems in the whole process and all aspects of medical device management. At present, hospitals at all levels pay more attention to the quality management of hospital clinical, medical, pharmaceutical and other disciplines, and have reasonably established complete management regulations, standard rules and control systems. However, the scientific management of medical devices is not well-recognized, the management level is uneven, and the implementation of supervision is not strong. Some hospitals have insufficient experience in the establishment of institutional systems and unified implementation of standard rules in the scientific management of medical devices. The scientific management system of medical devices is imperfect, the implementation of the system is not strict, and the quality control function is not obvious. It has lost its due guarantee, restraint and standardization in important aspects such as the procurement, use and tracking of medical devices.
2, extensive management of medical devices
The scientific management of medical devices is an important factor in ensuring the integrity of medical devices. With the rapid development of industrial manufacturing technology, biomaterial technology, and clinical diagnosis and treatment technology, medical devices are fast-changing and high-frequency, with development characteristics such as precision, safety, high efficiency and minimally invasive. However, the traditional extensive management mode is relatively lagging and scattered, lacking systematic and comprehensive management, and is not suitable for the development of modern medical devices, which is reflected in lag and dispersion. First, some hospitals lack the neglect of long-term development goals for medical device management, and long-term standards are blurred, making it difficult to form an efficient management model. Secondly, some hospitals are not accurate in the development trend of medical device equipment, and it is difficult to quickly follow up the management model. Medical device management personnel lag behind the management level of modern medical devices; the dynamic analysis and judgment ability of medical device life cycle status is not clear; the ability to achieve safety, quality and efficiency in control, management and technical support is not strong.
3. The quality of medical device management personnel is uneven
High-quality medical device management personnel are an important support for the scientific management of medical devices. The complexity and particularity of medical devices determine that medical device management is also a high-tech professional work with administrative supervision. The number of medical device management talents and the overall quality of the team cannot be well adapted to the rapid development of medical devices and hinder the scientific management of medical devices.
First of all, from the manager to the grassroots operators, the hospital pays insufficient attention to the Regulations on Medical Devices, has limited study time, and has a large difference in awareness and awareness of laws and regulations. Secondly, medical device management personnel mostly use drugs, medical and other professional backgrounds, lack of professional training, and low professional quality. Thirdly, the number of professional training institutions is small, the teachers are weak, and the medical device management personnel lack systematic and timely training. It is impossible to form a scientific understanding of medical device management and hinder the scientific management of medical devices.
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