Objective To compare product standards of drug and medical device made from sodium alginate and calcium alginate between domestic and abroad, and to emphases on the process parameters monitoring based on different standards. Methods Sodium alginate and calcium alginate standards of both domestic and foreign were analyzed and summarized, and the differences and commonalities of various product standards among each standard were compared. Results Differences exist in product standards of sodium alginate and calcium alginate between domestic and abroad, whether drug or medical device, but the fundamental control points are concordant. Conclusion Companies should focus on product quality control requirements combined with its own unique manufacturing process characteristics to develop reasonable and controllable quality standards, which can ensure safe and effective clinical use.
With nearly four decades of progress in healthcare-associated infection prevention and control in China, the national quality control efforts in this field have been ongoing for the past ten years, advancing rapidly with significant achievements. Over the last decade, the team of infection control professionals involved in quality management and control in China has consistently expanded, accompanied by an enhancement of their skills. Management capabilities have steadily grown, and operational mechanisms have been continuously refined. As public hospitals transition into a new phase of high-quality development, emphasizing refined management models and intrinsic development of medical quality, it becomes crucial to further fortify the foundation and foster innovation in infection control work to ensure quality. This article provides an overview of the establishment and implementation of the National Center for Quality Control of Infection Prevention and Control, examines the current shortcomings and challenges in the field, and collectively explores the positioning and direction of the development of quality control efforts for infection prevention and control in China.
It has been absent from an accepted criteria for normalization and quality control of the thoracic surgery until now. The ideal assessing instrument which will be used to evaluate the technical skills and surgical procedures should present a few vital characterizations below: objectivity, speciality in the content, detailed structure, and quantifiability. Objective structured assessment of technical skills (OSATS) has developed as a reliable method of surgical skills measurement. This article focuses on the history of OSATS and its prospect in the thoracic surgery area by reviewing relevant literatures.
ObjectiveTo summary the standardized management in research and applications of platelet derivatives for tissue regeneration.MethodsThe related literature about bottlenecks and standardized management of platelet derivatives in recent years was reviewed and analyzed.ResultsAlthough the platelet derivatives are increasingly used to accelerate the regenerative processes of injured joint, skin, nerve, ligament/tendon, and alveolar bone, etc., the large variation in preparation methods, diverse nomenclature, incomplete reporting system, and lack of quantitative and standardized management of the preparation process have caused uncertainty and incomparability of research and application results. In recent years, there has been a trend towards standardized research and management of platelet derivatives.ConclusionThe implementation of standardized research and quality management will contribute to promote the research and application of platelet derivatives in the field of tissue regeneration.
摘要:目的:总结汶川大地震中我院新生儿临时病房应急医疗实践,探讨灾难中新生儿医疗质量控制策略。方法:对“5·12”特大地震后1月(包括较大余震及唐家山堰塞湖防洪期间)我院新生儿3次转移后临时病房医疗工作的开展和质量控制过程进行回顾性分析。结果:灾害期间我院儿科新生儿病房的各项工作成效显著,其间的人员协调、院感控制、患者的转移,以及病案的管理,医疗核心制度的执行,均得到了充分的保证。结论:灾难期间,医务人员强烈的责任心和使命感、优良的职业素养和协作精神、完善的组织管理、扎实的抢救技能、妥善的转移安置,是完善医疗服务的必须。高度的质量安全意识,医疗核心制度、诊疗操作规范的严格执行,科学的应急予预案,是医疗质量安全的保障。
ObjectiveTo investigate the current situation of orthopedic quality control and management in county-level regional general hospitals in Guangdong, and to provide a scientific basis for further standardizing the procedures of orthopedic quality control and management in county-level regional general hospitals and continuously improving the work of provincial orthopedic quality control center.MethodsFrom June 2019 to July 2020, online and offline questionnaire survey and field survey were used to investigate the quality control and management of orthopedic departments in 22 county-level regional general hospitals in Guangdong.ResultsAmong the overall scores of the surveyed hospitals, the highest score was 96.5, the lowest score was 72.0. There were 6 hospitals with a total score of “excellent” (accounting for 27.3%). The “facilities and equipment” and “medical quality” of the surveyed hospitals were relatively valued. Taking Guangzhou, the capital of Guangdong as the center, the districts and counties were divided into the east, the south, the west and the north regions, and the difference in overall scores of orthopedics among the four regions was statistically significant (F=6.299, P=0.004). The unqualified rates of department setting, key technology development, average hospitalization days of representative diseases, equipment allocation, personnel allocation, department management and building layout were relatively high, which were 77.3%, 63.6%, 45.5%, 40.9%, 40.9%, 36.4% and 36.4%, respectively. Most hospitals had set up special debridement rooms in orthopedic department (95.5%), and the management and monitoring of the use of antibacterial drugs was mostly reasonable (90.9%). In terms of the level of orthopedic medical treatment, only 3 hospitals with sufficient key technologies reached the standard, accounting for 13.6%, and only 7 hospitals reached the standard of scientific research capacity, accounting for 31.8%. In terms of quality control, the numbers of hospitals with qualified medical record sampling (72.7%), perfect management and supervision mechanism (86.4%) and quality management team in departments (77.3%) were the least. In addition, among the investigated hospitals, beds were in short supply in orthopedic departments, with 12 hospitals accounting for 54.5% being deducted; 16 hospitals (72.7%) were deducted for unqualified doctor-patient ratio and 11 hospitals (50.0%) were deducted for unqualified nurse-patient ratio.ConclusionsThe overall level of orthopedics construction and management in the surveyed hospitals is uneven. The medical professional and technical level is insufficient. It is difficult to meet the practical needs, and there is an imbalance in the ratio of medical personnel. In the future, it is necessary to strengthen the quality control of orthopedic medical care, strengthen the medical technology training of county-level regional general hospitals and increase the medical and health resources and capital investment, so as to improve the quality control of county-level regional general hospitals.
Objective To monitor surgical quality and analyze learning curve of minimally invasive totally thoracoscopic cardiac surgery. Methods We retrospectively analyzed the clinical data of 150 consecutive patients who underwent minimally invasive totally thoracoscopic cardiac surgery in the Guangdong General Hospital between January 2013 and December 2015. There were 60 males and 90 females at age of 43.1 years. There were 60 patients with atrial or ventricular septal defect repair, 12 patients with cardiac tumor resection, 53 patients with mitral valve replacement and 25 patients with mitral valve repair. According to the surgical sequence, all the patients were divided into 3 groups including a group A, group B, and group C with 50 patients in each group (every 10 patients as a sequence, every 5 sequence as a group). Surgical outcomes were compared among the 3 groups, and surgical quality was analyzed with descriptive statistics. Results Surgical failure rate was 6.7% (10/150). There was no in-hospital mortality. Aortic cross-clamp time, cardiopulmonary bypass time and duration of mechanical ventilation, duration of ICU stay, duration of hospital stays of the group C were significantly shorter than those of the group A and group B. Analysis showed a significant learning curve effect in totally thoracoscopic cardiac surgery. When surgical cases reached about 100 cases, cardiopulmonary bypass and aortic cross-clamp time was shorter than the average value stably. Conclusion Totally thoracoscopic cardiac surgery is safe and reliable. For the beginners, it needs about 100 patients of surgery to master the totally thoracoscopic cardiac surgery.
Establishing and improving the quality control system of drug clinical trial institutions is the key to ensure the quality of clinical trial. In recent years, the number of drug clinical trial has been continuously improved, and the quality control requirements have been continuously improved. However, in clinical work, the workload of medical staff is heavy, and the energy devoted to clinical trial is limited. Clinical research coordinator (CRC), as a participant and coordinator of clinical trial, has carried out transactional work related to non-medical judgment under the authorization and guidance of researchers, and has undertaken any specific work in clinical trial. Based on the quality control management experience of nosocomial CRC and hospital drug clinical trial institutions in West China Hospital of Sichuan University, this paper discusses the mode of nosocomial CRC participating in clinical trial quality control. By participating in the quality control of clinical trial, the nosocomial CRC has improved the quality control efficiency, enriched the quality control team and improved the overall level of CRC. This model enriches the quality control system of drug clinical trial.