Human ; Research ; Information Dissemination ; Reference Standards

Fermented Chinese medicine has long been used. Amid the advance for preservation of experience, the connotation of fermented Chinese medicine has been enriched and improved. However, fermented Chinese medicine prescriptions generally contain a lot of medicinals. The fermentation process is complicated and the conventional fermentation conditions fail to be strictly controlled. In addition, the judgment of the fermentation end point is highly subjective. As a result, quality of fermented Chinese medicine is of great difference among regions and unstable. At the moment, the quality standards of fermented Chinese medicine are generally outdated and different among regions, with simple quality control methods and lacking objective safe fermentation-specific evaluation indictors. It is difficult to comprehensively evaluate and control the quality of fermented medicine. These problems have aroused concern in the industry and also affected the clinical application of fermented Chinese medicine. This article summarized and analyzed the application, quality standards, and the modernization of fermentation technology and quality control methods of fermented Chinese medicine and proposed suggestions for improving the quality standards of the medicine, with a view to improving the overall quality of it.
Medicine, Chinese Traditional ; Reference Standards ; Quality Control ; Fermentation

Objectives To learn the echocardiography skills of intensivists after receiving a basic critical care echocardiography training course, and investigate factors that may influence their performance. Methods We completed a web-based questionnaire that assessed the skills in ultrasound scanning techniques of intensivists who took a training course on basic critical care echocardiography held in 2019 and 2020. Mann-Whitney test was used to analyze the factors which might affect their performance on image acquisition, recognizing clinical syndrome, and measuring the diameter of inferior vena cava, left ventricular ejection fraction and left ventricular outflow tract velocity-time integral.Results We enrolled 554 physicians from 412 intensive care units across China. Among them, 185 (33.4%) reported that they had 10%-30% chance of being misled by critical care echocardiography when making therapeutic decision, and 34 (6.1%) reported that the chance was greater than 30%. Intensivists who performed echocardiography under the guidance of a mentor and finished ultrasound scanning more than 10 times per week reported significant higher scores in image acquisition, clinical syndrome recognition, and quantitative measurement of inferior vena cava diameter, left ventricular ejection fraction and left ventricular outflow tract velocity-time integral than those without mentor and performing echocardiography 10 times or less per week respectively (all P < 0.05).Conclusion The skills in diagnostic medical echocardiography of Chinese intensivists after a basic echocardiographic training course remain low, and further quality assurance training program is clearly warranted.
Humans ; Clinical Competence ; East Asian People ; Echocardiography/standards* ; Stroke Volume ; Ventricular Function, Left ; Self-Assessment ; Physicians/standards* ; Internal Medicine/standards*

China ; History of Medicine ; Medicine/standards*

On October 21, 2021, the National Medical Products Administration issued and implemented the Self-examination Management Regulations for Medical Device Registration. The regulations clarify the specific requirements of the registration applicants in the process of self-examination, and put forward detailed requirements from the aspects of self-examination ability, self-examination report, declaration materials and responsibility requirements, so as to ensure the orderly development of the self-examination of medical device registration. Based on the actual verification work of in vitro diagnostic reagent, this study briefly discussed the understanding of the relevant contents of the regulations, aiming to provide some reference for enterprises and related supervision departments that have the requirement of registered self-examination.
Medical Device Legislation ; Reagent Kits, Diagnostic/standards*

Standard drafting is an important part in the process of standard formulation and revision. By analyzing the status of the medical device industry standards drafting, thoughts and suggestions were proposed to further promote all relevant parties to actively participate in the standard drafting, effectively improve the quality of the standards, strengthen the technical support and promote the high-quality development of the industry. The statistical data of the participation of social organizations in the drafting and as the first unit drafting medical devices standards from 2017 to 2021 was researched, and the problems in the drafting of standards at this stage were analyzed. Based on the research and analyses, some thoughts and suggestions were proposed to strengthen the management of standard drafting units and promote the participation of all relevant parties in standard drafting. It is necessary to expand and enhance social participation in standard drafting further by innovating incentives, refining and strengthening normative requirements, and creating a positive social atmosphere.
Reference Standards ; China ; Industry

Medicinal plants or Chinese materia medica (CMM) are now attracting worldwide attention as they have increasingly prominent advantages over chemical drugs in disease treatment and healthcare. Since the 1990s, World Health Organization (WHO) and International Organization for Standardization established the Technical Committee of Traditional Chinese Medicine (ISO/TC 249) have carried out the development of quality standards on medicinal plants or CMMs respectively, and a considerable number of monographs and international standards have been published. Since the two international organizations adhere to different principles, the standards they develop naturally have different emphasis. Driven by market demand and international trade, ISO mainly takes quality, efficacy and safety into consideration when developing standards, while WHO pays more attention to clinical practice, quality control and medication guidance. Up to now, there is a lack of comparative analysis on the records, background, principles, basic content, and main requirements of quality standards on medicinal plants or CMMs respectively published by WHO and ISO. Therefore, based on international standards of CMM developed by ISO/TC 249 platform and WHO Monographs on Selected Medicinal Plants, this paper systematically compares the purposes, selected principles, standard-developing process, basic content, and main quality requirements to summarize their similarities and differences, and find their merits, aiming to serve as a reference to the development of international standards for CMMs that helps them go global.
Materia Medica/therapeutic use* ; Plants, Medicinal ; Commerce ; Internationality ; Medicine, Chinese Traditional ; Reference Standards ; Drugs, Chinese Herbal/therapeutic use* ; China

Humans ; Transcatheter Aortic Valve Replacement ; Consensus ; Aortic Valve Stenosis/surgery* ; Aortic Valve/surgery* ; Reference Standards ; Treatment Outcome ; Heart Valve Prosthesis

The revision of the national standards for drinking water quality is an important, rigorous and delicate endeavor. The paper introduced the revision of this standard, emphasizing the revision principle, overall technical considerations, and revision contents. Recommendations were also proposed for the implementation of this standard.
Humans ; Drinking Water ; Water Quality ; Reference Standards ; China ; Water Pollutants, Chemical/analysis* ; Water Supply

The establishment of limit values for standards of drinking water quality is an important and complex process. This study systematically introduced the methodology of the establishment of standard limit values for drinking water quality and elaborated on the workflow of setting limit values of water quality indicators, principles and methods of selecting water quality indicators, derivation of safety reference values, and establishment of limit values. It also aimed to provide reference and support for the future revision of relevant standards.
Humans ; Water Supply ; Drinking Water ; Reference Standards ; Water Quality ; Water Pollutants, Chemical/analysis*