Objective Tissue engineering advance in supplying the reparative and reconstructive medicine with promising tissue engineered medical products(TEMPs) and the new therapy alternative. The related supervision and administration of TEMPs is being developed and the standard research of TEMPs is also in progress. The Food and Drug Administration(FDA) of the United States has treated TEMPs as combined products and supervised them according to the level of risk to patients. Lately, FDA has determined that the Center for Devices and Radiological Health (CDRH) should take charge of examination and approval of TEMPs, with the cooperation of the Center for Biological Evaluations and Research(CBER). The regulatory controls have been established respectively in European Union and Japan. In China, TEMPs are identified as medical devices combined with cells. The Department of Medical Device of the State Food and Drug Administration (SFDA) is responsible for the examination and approval of TEMPs, and National Institute for the Control of Pharmaceutical amp; Biological Products(NICPBP) is responsible for evaluation tests. The standards of TEMPs are formulated mainly by the American Society of Testing Materials(ASTM) and International Standardization Organization(ISO).
ObjectiveTo analyze and evaluate the effect of the pharmacist-participated standardized drug management measures on improving the quality of drug management in day surgery center.MethodsDay surgery center carried out the pharmacist-participated standardized drug management since January 2019, including establishing a drug management group, strengthening the drug management specification, enhancing the training for standardized drug management, carrying out periodic inspection by pharmacist, etc. The Drug Management Quality Assessment Table was used to evaluate and compare the quality of drug management in day surgery center before standardized management (October 2018) and after standardized management (October 2019).ResultsThrough the standardized management, the quality of drug management in day surgery center was effectively improved, and the total score of drug quality management increased from 88.0 points before standardized management to 95.0 points after standardized management.ConclusionThe participation of pharmacists in the standardized drug management can effectively improve the quality of drug management in day surgery center, and ensure the safety of patients.
Medication adherence will directly affect the validity of primary endpoint indicator. This article discussed how to improve the medication adherence of clomiphene citrate based on PCOSact. We found that 20 (3+15+2) cases were "protocol violation" and there were cases in which researchers made mistakes while distributing medicine and guiding patients how to take medicine. Focusing on these problems we sumed up experience and emphasized the importance of medication compliance through the following aspects:(1) Improvement of insite supervision and remote monitoring; (2) Standardization training for research assistants; (3) Health education for subjects.
Traditional Chinese medicine equipment plays an indispensable role in the prevention, diagnosis, treatment and rehabilitation of traditional Chinese medicine from the needs of people's life and health, and provides technical support for the simple, convenient, cheap and effective clinical practice of traditional Chinese medicine. The traditional Chinese medicine equipment industry has the development advantages of large demand gap, strong policy support and emerging technology empowerment. At the same time, there are also bottlenecks such as lagging standardization construction, weak industrial foundation, insufficient characteristics of traditional Chinese medicine and immature evidence-based evaluation research. The coming of the era of digital intelligence has brought new opportunities for the development and reform of the traditional Chinese medicine equipment industry. This paper provides development ideas for the transformation of traditional Chinese medicine equipment from traditional to modern from the aspects of standardization construction, digital intelligence industry upgrading, improvement of evidence-based evaluation system and in-depth international exchanges and cooperation.
Emergency treatment of ocular trauma is a systematic and complicated work. Rapid and correct diagnosis and treatment are needed to maximize the recovery of ocular structure and function. In recent years, China has made remarkable progress in the emergency treatment of ocular trauma, including the development of Expert consensus on the norms of emergency treatment of ocular trauma in China (2019), the establishment of a national ocular trauma database, and the development of VisionGo Artificial Intelligence prediction system for ocular trauma. These measures improve the treatment level of ocular trauma and provide support for the prediction of postoperative visual acuity in severe traumatic eyes. However, with the development of economy and society, the characteristics of ocular trauma in our country have changed. For example, the majority of hospitalized patients were open ocular injuries, farmers and workers were the main occupational groups, and the proportion of eye injuries caused by traffic injuries increased year by year, and the proportion of women and minors increased. Although the annual loss of life of ocular trauma disability in China has decreased faster than the world average, the emergency treatment of ocular trauma still faces many challenges, such as regional differences, insufficient primary medical resources, lack of standardized training, and insufficient promotion of emergency treatment standards. In order to cope with these challenges, it is necessary to further strengthen the popularization of science and technology for the prevention and treatment of ocular trauma, standardize the emergency treatment process, strengthen the training of grass-roots medical personnel, strengthen the safety of emergency surgery, and pay special attention to the particularity of children's ocular trauma. In addition, relevant research has been actively carried out to establish a complete database of emergency patients with ocular trauma to promote the accurate prevention and treatment of ocular trauma.
In order to promote the implementation of the three standards of central sterile supply department (CSSD), new standards for cleaning and disinfection/sterilization of flexible endoscope, dental instruments, and environmental surface in healthcare, this article elaborates about central management of CSSD; management of loaners and implants; technique of autoclave sterilization, ethylene oxide sterilization, and hydrogen peroxide sterilization; high level disinfection or sterilization of flexible endoscope; disinfection and sterilization of dental instruments; daily and enhanced cleaning and disinfection of environmental surface in healthcare facilities. This could help clinical healthcare workers to implement these new standards, effectively prevent nosocomical infection, and guarantee the personal safety of patients.
Standardized resident training is one of the important contents of reform of the medical and health system. Meanwhile, it is the key part of education for medical graduates, and serves as a bridge for the cultivation of high-level medical talents. This article analyzes the necessity of standardized resident training, current situation and the difficulties faced, puts forward feasible suggestions based on previous practices, and envisions the future of training work.
Objective We aimed to investigate the attitude and suggestion from doctors, pharmacists and civil servants concerning brain death and organ transplantation and the legislation. Methods A questionnaire with 10 sections and 44 questions was designed and distributed. The effective questionnaire data was then recorded and checked for descriptive analysis. Results In 1 400 questionnaires distributed, 1 063 were responded and 969 of them were valid and analyzed. The respondents showed an incomplete understanding of brain death and organ transplantation laws. Seventy-four percent of the respondents recognized and accepted the standard of brain death. They agreed that legislation should be involved in the removal of organs for transplantation, the future use of the organs, and insurance and compensation for the donor for possible health risks induced by organ removal. Of the 969 respondents, 92% considered it necessary to have legislation in brain death and organ transplantation, and 61% thought that it is time to legislate. Conclusion Legislation for brain death and organ transplantation is urgent and timely in China. The laws must include the respective rights and obligations of patients, close relatives, and medical institutions. Educating the public about brain death and organ transplantation should also be encouraged in a variety of ways.
ObjectiveTo develop a standardized dataset for adverse drug reactions (ADR) of Chinese herbal formula granules (CHFG) to regulate the collection content of ADR, promote the standardization and normalization of ADR data collection for CHFG, and facilitate the sharing, integration, and analysis of adverse reaction data. MethodsWe used a combination of literature research, Delphi survey and consensus meeting. ResultsA Delphi survey questionnaire was constructed based on the results of literature research, including 6 domains and 76 items. After the Delphi survey and consensus meeting, a final CHFG adverse reaction dataset was developed, including 6 domains and 75 items. The six domains were patient details, suspected drugs, other treatments/concomitant medications, detailed information on the suspected adverse reaction, possible influencing factors (causes of the suspected adverse reaction), and details of the person reporting the suspected adverse reaction. Compared with the data collected by the National Adverse Drug Reaction Monitoring Center, this dataset introduced a new domain called "Possible influencing factors", which included several items such as irrational use of CHFG, toxic varieties of Chinese herbal medicine, storage and usage conditions, physical characteristics, processing methods, and patient diet. It also contained the information on Chinese medicine syndromes and other herbs in the prescription, and modified multiple items based on the particularities of formula granules. ConclusionThe development and application of this standardized dataset of ADR for CHFG can facilitate data collection, integration, and analysis, furthermore improve doctors' awareness of prescribing safely and enhance patient medication safety.
Consensus reporting items for studies in primary care (CRISP) is a newly developed measurement tool developed abroad to standardize primary health care research, so as to improve the quality of reporting and enhance the applicability, comprehensiveness, transparency and operability of reporting. The report contains 24 Entries that follow the Introduction, Methods, Results, Discussion (IMRaD) format, and is primarily concerned with describing the research team, the patients, the study subjects, the health status, the clinical experience, the health care team, the interventions, the study interventions, and the findings in the PHC study / implementation of results, etc. This article introduces and interprets the reporting guidelines to help researchers better understand and apply this statement to improve the quality of reporting in primary health care research