Current situation analysis of out-of-range use
Out-of-range use of medical devices means that the use of medical devices exceeds the "product scope" of medical device registration. This "scope" defines the scope of application of the medical device, the applicable population and the applicable place.
1. The use of medical devices beyond the scope of application
According to the requirements of the Regulations on the Supervision and Administration of Medical Devices, medical devices are marked with a clear scope of application at the time of registration, but they are often used beyond the scope of application in practical applications.
2. Medical devices are more suitable for people to use
Medical devices should have a clear applicable population and taboo population. In medical practice, the scope of the hospital to expand the population mainly has the following aspects: (1) the equipment that can only be used for part of the population is used for the whole; (2) The patient was not fully understood before examination, and the contraindications of the patient were ignored.
3. Use of medical devices in places beyond their application
Medical devices have a certain use of environmental standards to meet the established temperature and humidity, ventilation, electromagnetic environment, radiation protection and other requirements. Some hospitals ignore the corresponding regulations during construction, resulting in the use of medical devices beyond the applicable places.