Chinanews.com, August 26. According to the website of the National Health Commission, the General Office of the National Health Commission recently issued a notice stating that in order to further standardize and strengthen the clinical application and management of human organ transplantation technology, the National Health Commission organized experts to review the "Liver, The Technical Management Standards for Kidney, Heart, and Lung Transplantation (Weiyifa [2006] No. 243) were revised to form the "Management Standards for the Clinical Application of Human Organ Transplantation Technology (2020 Edition)" (hereinafter referred to as the "Management Standards"). The "Management Regulations" abolished the level restrictions on medical institutions that carry out human organ transplantation technology.
The General Office of the National Health Commission stated that in June 2006, the former Ministry of Health issued the "Regulations for the Technical Management of Liver, Kidney, Heart, and Lung Transplantation" (Weiyifa [2006] No. 243) to standardize the clinical application of human organ transplantation in China It played an important role. With the continuous deepening of the cause of organ donation and transplantation in China, the "Technical Management Regulations for Liver, Kidney, Heart, and Lung Transplantation" issued in 2006 can no longer meet the current needs for the high-quality development of human organ donation and transplantation. Pancreas and small intestine transplantation operations Also mature gradually. Therefore, the National Health Commission initiated the revision of the "Technical Management Specifications for Liver, Kidney, Heart, and Lung Transplantation" in 2019, and added the technical management specifications for pancreas and small bowel transplantation.
In accordance with the reform spirit of the State Council’s “delegation of control and service”, the “Management Regulations” abolished the level restrictions on medical institutions that carry out human organ transplantation technology. At the same time, the requirements for the management of the clinical application of human organ transplantation in medical institutions have been strengthened. First, it is clear that medical institutions need to have a clinical application and ethics committee for human organ transplantation that meets the requirements; the second is the establishment and standardization of the management of human organ transplantation technology in medical institutions. Carry out the requirements; the third is to refine the site, equipment and facility requirements for the development of human organ transplantation technology, and further clarify the conditions for the development of liver, kidney, heart, lung, pancreas, small intestine and other human organ transplantation technologies. .
The "Management Regulations" canceled the requirements for the number of surgical cases related to human organ transplant doctors; it is clear that the clinical application of human organ transplantation technology should be carried out by human organ transplant doctors recognized by the provincial health administrative department or the military health department, and the medical institution The number of human organ transplant doctors in related transplant projects has put forward specific requirements; related requirements have been added for brain death determination technicians and transplant data network direct reporting personnel.
The "Management Regulations" canceled the non-technical management requirements such as cold ischemia time during the preservation of human donated organs that should be stipulated in the relevant professional diagnosis and treatment specifications, and the number of human organ transplant operations carried out by medical institutions. Adjusted the preoperative inspection items for some human organ transplants; further strengthened the main responsibility of medical institutions, and put forward specific requirements for the admission of human organ transplant physicians, the implementation of transplant operations, ethical review procedures, and transplant quality management in medical institutions. Clearly regulate the use of China Human Organ Distribution and Sharing Computer System (COTRS), and complete relevant data reporting within 72 hours after surgery.