National Health And Safety Commission: This kind of medical equipment, the national hospital deactivation

these devices are immediately deactivOn February 4, the National Health and Safety Commission issued the Measures for the Clinical Use of Medical Devices (hereinafter referred to as the Management Measures).In the clinical use management section, if the medical device used is found to be in danger of safety, the medical institution shall immediately stop using it and notify the medical device registrant, filer or other institution responsible for product quality to carry out the maintenance;These Measures shall apply to the supervision and management of medical devices used in clinical practice in various medical institutions at all levels.According to the Measures for The Administration of Medical Measures, medical institutions and their medical personnel shall follow the principles of safety, effectiveness and economy and adopt medical devices adapted to the patient's disease for diagnosis and treatment activities.If it is necessary to explain to the patient the relevant matters related to the clinical use of medical devices, it shall be truthfully informed, and shall not conceal or falsely publicize or mislead the patient.At the same time, medical institutions shall carry out safety management for the clinical use of medical devices and implement a safety monitoring and reporting system for the use of life support, first aid, implants, radiation, sterilization and large-scale medical devices.Develop an emergency replacement process for life-support medical devices and related important medical device failures that match their scale and function, equip them with the necessary replacement equipment facilities, and implement special management for medical devices for first aid to ensure the normal development of clinical first aid work.Medical institutions shall carry out clinical use evaluation of medical devices in accordance with the provisions, with emphasis on strengthening the evaluation of clinical effectiveness, reliability and availability of medical devices.

disposable devices must not be reusedFor disposable medical devices, the above-mentioned Measures require medical institutions to strictly implement the provisions of relevant laws and regulations on hospital infection management and to use disinfection equipment and disposable medical devices in accordance with state regulations.Medical devices that can be reused in accordance with the provisions shall be cleaned, disinfected or sterilized in strict accordance with the provisions, and the effects shall be monitored; medical devices used for one-time use shall not be reused and those used shall be destroyed and recorded in accordance with the relevant provisions of the State.Before using sterile medical devices, the packaging and expiration date of direct contact medical devices shall be routinely checked, and their specifications, models, disinfection or sterilization effective dates shall be carefully checked. If the packaging is damaged, marked unclearly, exceeds its expiration date or may affect the safety of use, it shall not be used.Disposable consumables re-use has always been one of the hot topics in the industry.Doctors who have been on the front line of surgery for years say they are particularly concerned about the huge waste of disposable supplies used in surgery, the People's Daily reported.Through research, the doctor found that a large number of disposable consumables, including ultrasound heads, can be reused after strict disinfection, which not only reduces the financial burden on patients, but also saves a lot of money on health care.But he also found that the disposable use of consumables good supervision, but strict disinfection after reuse risk prevention and control is more complex.   This issue was also mentioned by the National Health Insurance Administration in its Response to Recommendation 6395 of the Second Session of the 13th National People's Congress in August 2019.   The State Administration of Medical Insurance said that the recycling of disposable medical supplies involves the People's Republic of China Infectious Disease Prevention and Control Law, the Regulations on the Supervision and Administration of Medical Devices and other laws and regulations, the safety and effectiveness of reuse products and other technical support, the economic feasibility of reuse, social ethics and doctor-patient relations and other aspects, need to be jointly studied and promoted by various departments.   Next, the State Drug Administration will cooperate with relevant departments to carry out high-value medical supplies re-use work, in the re-use of products function verification, safety and effectiveness assurance and other technical levels to provide support.
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