As a product of modern science and technology, with the rapid development of medical diagnosis and treatment technology, medical devices have been widely used in disease prevention, diagnosis, treatment, health care and rehabilitation. Whether it is high-end or low-end products, its reliability is the core concern. From thermometers, disposable infusion sets to monitors and ventilators, from pacemakers, artificial blood vessels to intravascular stents and artificial joints, most of the medical work in hospitals needs the assistance of medical devices. Not only that, many medical devices will be implanted into the human body temporarily or for a long time. For medical personnel, the reliability of medical devices is impossible to avoid.
The low reliability of medical devices will not only cause economic losses, reduce the reputation of manufacturers, but also directly endanger the life safety of patients. For a long time, the quality of some medical devices in China is unstable, the failure rate is high, and the reliability is low. It is estimated that there are at least 40000 device adverse events in China every year. In view of this, the general provisions of the "Regulations on the supervision and administration of medical devices" promulgated by the State Council in 2000 clearly stated that the safety and effectiveness of medical devices implanted into the human body to support and maintain life, which are potentially dangerous to the human body, must be strictly controlled; Article 32 of Chapter IV of the "Regulations" stipulates that medical devices that cannot be guaranteed to be safe and effective shall be controlled by people at or above the provincial level The drug administration of the people's Republic of China has revoked its product registration certificate.
Contents of medical device reliability engineering
Medical device reliability engineering is a series of work, such as reliability design, test, production and management, in order to meet the reliability requirements of medical devices and their parts. It runs through all links of medical device design, production, inspection, packaging, transportation, storage, use and maintenance, and is a systematic engineering. Among them, design is the most important. On the one hand, to solve the reliability problem in the design process, the cost is the lowest and the loss is the smallest; on the other hand, the injury events in recent years reveal that if the design is unreasonable, it is almost impossible to achieve the expected reliability index only through training, warning and correction after problems.
Therefore, personnel engaged in the design and development of medical devices must fully understand and master the theory and method of reliability research, so that the developed products have clear and effective reliability indicators, the design can be predicted, the test can be detected, the production can guarantee the process and results, and the performance of medical devices in use can be stable and reliable It can be controlled in the whole product life cycle. On the basis of reliability research, the design, test, manufacture and use of medical devices need to be controlled under a reliability based management system. Through the rational use of management technology, the reliability goal can be achieved and the safety and effectiveness of public use of medical devices can be guaranteed.
Reliability design stage of medical devices
According to the needs of medical activities, medical device manufacturers clearly put forward the requirements for the reliability of medical devices. At the same time, when studying the reliability requirements of medical devices, enterprises should fully consider the reliability status, existing technical level, cost, function, use environment and other factors of existing medical devices. The main contents of the reliability design of medical devices include: methods, approaches and organizational measures to achieve the reliability index. Production enterprises need to formulate corresponding implementation plan, quality control plan, reliability verification test plan, personnel training plan and reliability data management plan, and have the means to check the implementation of the plan.
Medical device development stage
On the basis of basic research and exploration of new technology application, various alternative schemes are formed, effective measures are put forward, samples are designed and constructed, and samples are strictly tested and identified. Evaluate the cost of the production and use of medical devices, provide the necessary information for the production and use, and comply with the provisions of the provisions on clinical trials of medical devices.
Batch production of medical devices
In order to ensure the reliability and maintainability of products to meet the design requirements, effective and feasible inspection systems and methods should be established in the process of reliability control. For class II and class III medical devices that have certain risks and need to take control measures, a standardized and effective tracking system should be established.
Use stage of medical devices
The use stage of medical devices includes storage, transportation, regular inspection, preparation before use, use and maintenance according to the specified purpose. The basic task of this stage is to maintain the reliability of medical devices and improve the maintainability and safety of medical devices. It should be pointed out that the reliability of medical devices is designed, produced and managed. In the whole life cycle of medical devices, the activities of reliability engineering have two parallel processes: one is engineering technology process. In the stage of product design and development, the inherent reliability of medical devices can be improved through reliability design and design improvement; the other is reliability management. In the production stage, various quality tools are used to reduce the variation of production parameters, control the product quality and realize the reliability of the product in the design stage; in the use stage, the product is effectively managed and maintained to maintain the inherent reliability of the product.
The ultimate goal of the research on the reliability of medical devices is: within the service life promised by the product registration, the medical devices will give full play to the expected effect, with high reliability, high safety and convenient maintenance, so as to lay a theoretical and technical foundation for the realization of the overall goal of the safety and effectiveness of medical devices.
The improvement of the reliability of medical devices is a systematic project, which involves a lot of work. It requires medical enterprises, manufacturing enterprises and government regulators to continuously improve the understanding and application ability of the reliability of medical devices, so as to realize the growth of the reliability of medical devices and the improvement of the government's supervision and implementation ability. In the future, the research on the reliability of medical devices will become a new research hotspot, and will play an important role in achieving the safety and effectiveness of medical devices.