On April 21, the National Health Commission issued the National Restricted Technology Catalogue (2022 Edition) and the National Restricted Technology Clinical Application Management Specification (2022 Edition), adjusting the National Restricted Technology Catalogue from 15 to 12.
The source | the official website of the National Health Commission
On April 21, the National Health Commission issued the National Restricted Technology Catalogue (2022 Edition) and the National Restricted Technology Clinical Application Management Specification (2022 Edition), which adjusted the national restricted technology catalogue from 15 to 12 items, clarified the disease diagnosis and surgical operation code corresponding to the national restricted technology, and further improved the national restricted technology clinical application management specifications and medical quality control indicators.
The Catalogue deletes five technologies of allogeneic skin grafting, deep tumor hyperthermia and systemic hyperthermia, artificial intelligence-assisted diagnosis, craniomaxillofacial deformity craniofacial surgical correction and oral and maxillofacial tumor combined radical treatment from the previous catalogue, and adds two national restricted technologies of extracorporeal membrane oxygenation (ECMO) and autologous organ transplantation. In addition, each technology is corresponding to the "National Clinical Edition 2.0 of Disease Classification and Code" or the "National Clinical Edition of Surgical Operation Classification Code 3.0", which is convenient for health administrative departments at all levels and medical institutions to carry out scientific and accurate management work, and further lays the foundation for the realization of information management of clinical application of restricted technologies. At the same time, it is clearly stipulated that "disease diagnosis and surgery/operation that are not included in the code are not managed as national restricted technologies".
The "Specification" formulates clinical application management specifications and medical quality control indicators for new ECMO technology and autologous organ transplantation technology, and revises the 10 national restricted technology clinical application management specifications and medical quality control indicators retained. In addition, according to the actual situation, the requirements of medical institutions, personnel, technical management and training management have been optimized, and the definition, calculation formula and significance of relevant quality control indicators have been improved, which is convenient for medical institutions to implement and apply.
The National Health Commission requires that all provincial-level health administrative departments should organize forces to conduct research and demonstration on the 5 technologies that have been adjusted out of the national restricted technology catalog this time, and clarify whether they are included in the provincial restricted technology catalog. All types of medical institutions at all levels should carry out the clinical application of national restricted technologies in accordance with the requirements and norms, and timely, accurately and completely submit data and information on the development of restricted technologies to the national and provincial medical technology clinical application information management platforms on a case-by-case basis. Quality control organizations and industry associations at all levels should provide technical support and guidance for medical institutions to carry out the clinical application and management of relevant technologies according to their own work responsibilities.
Related interpretations
1. Background of the revision
The management of clinical application of medical technology is an important part of the modern hospital management system, which is of great significance for standardizing the clinical application of medical technology and ensuring medical quality and safety. In 2015, after the cancellation of the access management of the clinical application of the third type of medical technology, the Commission carried out the filing management of medical technology that "restricted clinical application" and strengthened the supervision during and after the event. In 2017, the Committee issued relevant documents to clarify the management norms and quality control indicators for medical institutions to carry out "restricted clinical application" medical technology. In 2018, we commissioned the issuance of the Administrative Measures for the Clinical Application of Medical Technology to establish a "negative list" management system for the clinical application of medical technology. In recent years, with the continuous deepening of the work, the 2017 edition of the "Restricted Clinical Application" medical technology management specifications and quality control indicators have no longer adapted to the current medical technology clinical application management requirements. To this end, our committee organized the revision and formation of the "National Restricted Technology Catalog and Clinical Application Management Specifications (2022 Edition)".
2. Revised content
(1) Adjust the catalogue of national restricted technologies. The five techniques of allogeneic skin grafting, deep tumor hyperthermia and systemic hyperthermia, artificial intelligence-assisted diagnosis, craniofacial surgical correction of craniomaxillofacial deformity, and combined radical treatment of oral and maxillofacial tumors were removed from the catalog. Two new national restricted technologies have been added: extracorporeal membrane oxygenation (ECMO) and autologous organ transplantation. After the adjustment, the catalogue of restricted technologies in the country has been changed from 15 items to 12 items.
(2) Clarified the disease diagnosis and surgical operation code corresponding to the national restricted technology. Each technology corresponds to the "National Clinical Edition 2.0 of Disease Classification and Code" or the "National Clinical Edition of Surgical Operation Classification Code 3.0", which is convenient for health administrative departments at all levels and medical institutions to carry out scientific and accurate management work, and further lays the foundation for the realization of the information management of the clinical application of restricted technologies. At the same time, it is clearly stipulated that "disease diagnosis and surgery/operation that are not included in the code are not managed as national restricted technologies".
(3) Further improve the management norms for the clinical application of national restricted technologies and the indicators of medical quality control. Clinical application management specifications and medical quality control indicators were formulated for the newly added extracorporeal membrane oxygenation (ECMO) technology and autologous organ transplantation technology, and the 10 national restricted technology clinical application management specifications and medical quality control indicators were revised. According to the actual situation, the requirements of medical institutions, personnel, technical management and training management have been optimized, and the definition, calculation formula and meaning of relevant quality control indicators have been improved to facilitate the implementation and application of medical institutions.
3. Work requirements
Health administrative departments at all levels and all types of medical institutions at all levels should strictly follow the "Administrative Measures for the Clinical Application of Medical Technology", adjust their own management policies and strategies in accordance with the newly revised national restricted technology catalogue and its clinical application management norms and quality control indicators, and strengthen the management of the clinical application of relevant technologies. Each provincial-level health administrative department shall organize forces to conduct research and demonstration on the 5 technologies adjusted out of the national restricted technology catalogue this time, and clarify whether they are included in the provincial restricted technology catalogue. All types of medical institutions at all levels should carry out the clinical application of national restricted technologies in accordance with the requirements and norms, and timely, accurately and completely submit data and information on the development of restricted technologies to the national and provincial medical technology clinical application information management platforms on a case-by-case basis. Quality control organizations and industry associations at all levels should provide technical support and guidance for medical institutions to carry out the clinical application and management of relevant technologies according to their own work responsibilities.
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