Article 4, the equipment and consumables in accordance with the "large equipment in and out of the warehouse system", "medical equipment maintenance system", "medical equipment scrapping system" and "general medical equipment management system" requirements, to do a good job in the installation and acceptance, in and out of the warehouse, maintenance and scrapping management.
Article 5, the medical equipment procurement, evaluation, acceptance and other processes such as the formation of reports, contracts, evaluation records and other documents for archiving and proper preservation, preservation period for the end of the life cycle of medical equipment for more than 5 years.
Article VI, engaged in medical devices related to the work of technical personnel, should have the appropriate professional qualifications, technical titles or through the relevant technical training, and access to state-recognized technical qualifications for practice.
Article VII, the clinical use of medical devices and medical equipment to ensure the establishment of medical engineers and technicians training, assessment system. Organizations to carry out new products, new technologies before the application of standardized training, to carry out the clinical use of medical devices in the process of quality control, operating procedures and other related training, the establishment of training files, regular inspection and evaluation.
Article VIII, clinical use of medical devices should be strictly in accordance with the product instructions, technical specifications and procedures, contraindications and precautions for the product should be strictly comply with the need to explain to the patient should be truthfully informed of the matters shall be no false propaganda, misleading patients.
Article IX, the occurrence of medical device failure, the use of the department should immediately stop using, and notify the equipment section in accordance with the provisions of the overhaul; by the overhaul does not meet the safety standards for clinical use of medical devices, shall not be used in the clinic.
Article 10, the occurrence of clinical use of medical devices and adverse reactions to safety events, clinical departments should be promptly dealt with and reported to the quality control section and the Committee, the quality control section reported to the higher health administrative departments and drug and food supervision and management bureau.
Article 11, the strict implementation of the "Hospital Infection Management Measures", "single-use sterile and peacekeeping force equipment management system", "Medical Waste Management Regulations," the relevant provisions of the disinfection of medical equipment and single-use medical devices related to the proof of audit. Single-use medical devices shall not be reused according to relevant laws and regulations, and medical devices that can be reused according to regulations shall be cleaned, disinfected or sterilized in strict accordance with requirements, and the effect shall be monitored. Medical personnel in the use of various types of medical supplies, should carefully check its specifications, models, sterilization or expiration date, etc., and registration and processing.
Article 12, the clinical use of large-scale medical equipment, implantable and interventional medical devices, the name, key technical parameters and unique identification information should be recorded in the medical record
Article 13, the development of medical equipment installation, acceptance (including commercial, technical, clinical) in the use of the management system and technical specifications.
Article 14: To analyze and assess the risk of preventive maintenance, testing and calibration of in-use equipment and medical devices, as well as the effectiveness of clinical use, in order to ensure that the in-use equipment and medical devices are in good condition and ready for use, and to ensure the quality of the clinical information obtained. Preventive maintenance program content and procedures, techniques and methods, time intervals and frequency, should be developed in accordance with the relevant norms and the actual situation of medical institutions
Article 15, in the use of large-scale medical equipment in a conspicuous place, the main information about the medical equipment, including the name of the medical device, registration number, specifications, manufacturers, date of launch and equipment management personnel.
Article 16: In accordance with the technical guidelines for medical devices and relevant national standards and regulations, regular testing, evaluation and maintenance of the environment for the use of medical devices.
Article 17: For life-support equipment and important related equipment, the establishment of appropriate emergency backup program.
Article 18: The whole process of medical device protection technology services and its results should be recorded and stored in the medical device information file.
Specific reference to the "safety management system for the clinical use of medical devices"
.