On February 17, the National Health and Family Planning Commission released 15 “Restricted Clinical Applications†medical technology management practices and quality control indicators including the Hepatocyte Stem Cell Transplant Technology Management Regulations (2017 version).
First, the background
Medical technology, as one of the elements of medical services, is directly related to medical quality and medical safety. In 2009, we issued the “Administrative Measures for Clinical Application of Medical Technology†(Wei Zheng Zheng Fa [2009] No. 18) in the form of a normative document. The classification and grading management of medical technology clinical applications were clearly divided into three categories. Implementing access management for the second and third types of medical technology. At the same time, relevant third-class medical technology management norms were issued, and the third-class medical technology clinical application management was strengthened.
In May 2015, the State Council issued the “Decision on Cancellation of Non-Administrative License Approval Items†(Guo Fa [2015] No. 27), and cancelled the third-class medical technology clinical application approval project. In order to implement the requirements for the reform of the administrative examination and approval system of the State Council, the Commission issued the Notice on Cancellation of the Relevant Work on the Approval of the Clinical Application of the Third Class of Medical Technology (National Health Medical Fa [2015] No. 71, hereinafter referred to as the Notice). In accordance with the principle of “simplified administration, decentralization, and optimization of services†and the principle of “open, transparent, and supervisableâ€, the approval of the third-class medical technology clinical application approval will be cancelled, and six “negative list†management systems will be established. The system and an information platform will strengthen the clinical application management of medical technology and strengthen post-event supervision. The "Notice" also clarified that the negative list of medical technology is divided into "prohibited technology" and "restricted technology", and the principle of restricted technology classification and 15 restricted technology projects are proposed. The original third-class medical technology management norms have not adapted to the current medical technology management requirements, and need to be updated.
Second, the revision process
In order to ensure that the clinical application management policy of medical technology falls as soon as possible and achieve a smooth transition after policy adjustment, the Commission initiated the revision and revision of technical management standards. More than 10 professional academicians including orthopedics, extracardiac, extrathoracic, blood, tumor, transplantation, oral cavity, etc., more than 140 authoritative experts such as the chairman and deputy director of the Chinese Medical Association, participated in the meeting and carefully studied and drafted 15 restrictions. Class technical management norms, and drafted 15 restricted-type technical medical quality management indicators. On the basis of the opinions of the 31 provinces (autonomous regions and municipalities) and the Xinjiang Municipal Production and Construction Corps Health and Family Planning Administration, the State Administration of Traditional Chinese Medicine, the Health Bureau of the Military Commission Logistics Department, the Chinese Medical Association and the Chinese Stomatological Association, To improve, the 15 "constrained clinical application" medical technology management norms and quality control indicators such as the Hematopoietic Stem Cell Transplant Technology Management Regulations (2017 edition) were finally formed.
Third, the main content
15 “Restricted Clinical Applications†Medical Technology Management Regulations and Quality Control Indicators, such as the Hepatocyte Stem Cell Transplant Technology Management Regulations (2017 Edition), clarify 15 “Restricted Clinical Application†medical technologies for medical institutions and their physicians to carry out hematopoietic stem cell transplantation technology. Basic conditions that should be met: including basic requirements for medical institutions, basic requirements for personnel, basic requirements for technical management, and training management requirements. At the same time, the medical quality control indicators of 15 “limited clinical applications†medical technologies such as hematopoietic stem cell transplantation technology were clarified. Medical institutions intending to restrict clinical application of medical technology should have the above conditions before they can carry out and participate in the quality control of medical technology as required.
The following is the original text:
Notice of the 15th “Restricted Clinical Application†Medical Technology Management Regulations and Quality Control Indicators issued by the General Office of the National Health and Family Planning Commission on the issuance of the Hepatocyte Stem Cell Transplant Technology Management Regulations (2017 Edition)
National Health Service Medical Journal [2017] No. 7
Health and Family Planning Commission of all provinces, autonomous regions and municipalities directly under the Central Government, Xinjiang Production and Construction Corps Health Bureau:
In order to further strengthen the post-event supervision of medical technology clinical application, do a good job in the clinical application management of "restricted clinical application" medical technology, standardize clinical behavior, and guarantee medical quality and medical safety, I organized the organization to repair the hematopoietic stem cells. 15 technical guidelines for the management of transplant technology (2017 edition) and other “restricted clinical applicationsâ€, and the quality control indicators of the corresponding technologies (downloadable from the website of the National Health and Family Planning Commission). Is issued to you, please follow.
China Pigment Suppliers
Here you can find the related products in Pigment, we are professional manufacturer of Pigment. We focused on international export product development, production and sales. We have improved quality control processes of Pigment to ensure each export qualified product.
If you want to know more about the products in Pigment, please click the Product details to view parameters, models, pictures, prices and Other information about Pigment.
Whatever you are a group or individual, we will do our best to provide you with accurate and comprehensive message about Pigment!
Lycopene, Amaranth, β-Carotene, Beta carotene, Carmine, Food Colorant
Xi'an Gawen Biotechnology Co., Ltd , https://www.ahualyn-bios.com