How to strengthen the safe use of medical equipment management

Article 3, in order to ensure that the clinical use of medical equipment Legitimate, safe and effective, for the first time into the hospital to use medical equipment in strict accordance with the "health consumables for the first time into the hospital's requisition procedures" and "the acquisition and introduction of medical equipment system" in the requirements of the access; on the procurement of equipment in strict accordance with relevant laws and regulations procurement norms, unified entrance, legal channels, complete procedures; the procurement of medical equipment to do a timely internal disclosure; in the use of equipment and supplies to be evaluated annually and updated. The procurement of medical equipment shall be made public in a timely manner; the equipment and consumables in use shall be evaluated and demonstrated annually, and opinions shall be updated in a timely manner. Article 4, the equipment and consumables in accordance with the "large equipment in and out of storage system", "medical equipment maintenance system", "medical equipment scrapping system" and "general medical equipment management system" requirements, to do a good job of installation and acceptance, in and out of storage, 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 the medical equipment for more than 5 years. Article 6, engaged in medical equipment related work of technical personnel, should have the appropriate professional qualifications, technical titles or through relevant technical training, and obtain the state-recognized technical level of practice qualifications. Article 7, the clinical use of medical devices and medical equipment to ensure the establishment of medical engineers and technicians training, assessment system. Organize and carry out the standardized training before the application of new products and technologies, carry out the quality control in the process of clinical use of medical devices, operating procedures and other related training, establish training files, regular inspection and evaluation. Article 8, the clinical use of medical devices should be strictly in accordance with the product instructions, technical specifications and procedures, product contraindications and precautions should be strictly observed, need to explain to the patient should be truthfully informed of the matters, shall not carry out false propaganda, mislead the patients. Article 9, in the event of medical device failure, the use of the department shall immediately stop using, and notify the equipment section in accordance with the provisions of the overhaul; after the overhaul does not meet the safety standards for clinical use of medical devices, shall not be used in the clinic again. Article 10: In the event of adverse reactions and safety incidents of clinical use of medical devices, the clinical department shall promptly deal with and report to the quality control department and the committee, and the quality control department shall report to the higher health administrative department and the Drug and Food Supervision and Administration Bureau. Article 11: Strictly implement the "Hospital Infection Management Measures", "Single-use Sterile and Peacekeeping Force Instrument Management System", "Medical Waste Management Regulations", and review and approve the relevant certificates of sterilized instruments and single-use medical devices. 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 medical equipment, implantable and interventional medical device 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 business, technology, clinical) in the use of management systems and technical specifications. Article 14: To analyze and assess the risk of preventive maintenance, testing and calibration of in-use equipment and medical devices, and the effect of clinical application, 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 clinical information obtained. Preventive maintenance program content and procedures, technology and methods, time interval and frequency, should be formulated in accordance with relevant norms and the actual situation of the medical institutions Article 15, in the use of large-scale medical equipment in a conspicuous position in the Department of medical equipment, the main information about the medical equipment, including the name of the medical device, the registration number, specifications, manufacturers, date of commissioning and equipment management personnel and other content. Article 16: In accordance with the technical guidelines for medical devices and relevant national standards and regulations, the use environment of medical devices shall be tested, evaluated and maintained on a regular basis. Article 17: For the life-supporting equipment and important related equipment, the company shall formulate the corresponding emergency backup plan. Article 18: The whole process of medical device protection technology service and its results shall be truly recorded and stored in the medical device information file. Specific reference to the "clinical use of medical devices safety management system"