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.
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.
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
ObjectiveTo explore the application effect of standardized management on video-electroencephalogram (VEEG) monitoring.MethodsIn January 2018, a multidisciplinary standardized management team composed with doctors, technicians, and nurses was established. The standardized management plan for VEEG monitoring from outpatient, pre-hospital appointment, hospitalization and post-discharge follow-up was developed; the special quilt for epilepsy patients was designed and customized, braided for the patient instead of shaving head, standardized the work flow of the staff, standardized the health education of the patients and their families, and standardized the quality control of the implementation process. The standardized managemen effect carried out from January to December 2018 (after standardized managemen) was compared with the management effect from January to December 2017 (before standardized managemen).ResultsAfter standardized management, the average waiting time of patients decreased from (2.08±1.13) hours to (0.53±0.21) hours, and the average hospitalization days decreased from (6.63±2.54) days to (6.14±2.17) days. The pass rate of patient preparation increased from 63.14% to 90.09%. The capture rate of seizure onset increased from 73.37% to 97.08%. The accuracy of the record increased from 33.12% to 94.10%, the doctor’s satisfaction increased from 76.34±29.53 to 97.99±9.27, and the patient’s satisfaction increased from 90.04±18.97 to 99.03±6.51. The difference was statistically significant (P<0.05).ConclusionStandardization management is conducive to ensuring the homogeneity of clinical medical care, reducing the average waiting time and the average hospitalization days, improving the capture rate and accuracy of seizures, ensuring the quality of medical care and improving patient’s satisfaction.
Objective To explore the application of the Handbook for the Training Nurses in the standardized training for nurses in pediatric surgery. Methods Twenty-four training nurses trained under the instruction of the Handbook for the Training Nurses in Department of Pediatric Surgery from July 2014 to December 2015 were included as the observation group. Their training effects were compared historically with those of twenty-four training nurses who were trained without the help of the handbook from January 2013 to June 2014 (the control group). Results After the completion of the half-year training, theoretical score of training nurses in the observation group was better than that in the control group, and the difference was significant (87.16±4.18 vs. 83.71±5.46; t=2.492, P=0.016). Meanwhile, the specialist practical skill examination of training nurses in the observation group, such as femoral vein blood collection, replacement of drainage bag and indwelling needle infusion in children, and emergency practical skill examination such as cardiopulmonary resuscitation and the use of simple respirator were higher than those in the control group; and the working performance scores of training nurses in the observation group, such as the ability to adapt to the environment, patient satisfaction, nursing document writing, work efficiency and morning questions were better than those in the control group; the differences were significant (P< 0.05). Conclusion The Handbook for the Training Nurses can help the training nurses to adjust their working environment, master the practical skills and nursing knowledge in pediatric surgery.
ObjectiveTo summary the standard treatment for early gastric cancer. MethodsThe current early gastric cancer treatment guidelines around the world were analyzed and the standardized treatment patterns for early gastric cancer were concluded. ResultsThe accurate preoperative evaluation for early gastric cancer is the basis of standardized treatment which can be divided into staging evaluation and histological evaluation.The staging evaluation is focused on the gastric wall invasion and lymph node involvement of the tumor while the histologic evaluation emphasize the histological type and grading of the tumor.According to the precise evaluation for early gastric cancer, endoscopic surgery, laparoscopic surgery, open surgery, and multimodal therapy can be applied individually to the patients.Different treatment methods have their indications, but the indications of the therapies in different guidelines are suggested with slight differences. ConclusionIn clinical practice, the choice of treatment should be made with comprehensive consideration of diagnosis and individual characteristics of patients to achieve the most benefit on prognosis.
The Standards for reporting diagnostic accuracy studies (STARD) 2015 is a revision of the STARD 2003 on the checklist and flow chart, on the basis of the new evidences of potential bias and applicability, to better guide the application of diagnostic test in clinical practices. Currently, the interpretation and application in China is still based on STARD 2003. This review will describe the application status of the original version and introduce the updated standards for reporting diagnostic accuracy studies.
ObjectiveTo explore medical waste management method in a large hospital and strengthen the standardized management of medical waste. MethodsBetween July 2012 and December 2014, according to the PDCA cycle working procedures, existing problems were found in medical waste management through survey, the cause of which was analyzed to formulate and implement a new system of medical waste management, to help carry out employee training and cross examination, and give feedback to clinical departments to make improvements. Then, we analyzed the awareness rate of medical waste-related knowledge among medical staff, accuracy rate of medical waste disposal, average daily medical waste amount before and after the application of PDCA cycle to evaluate the effect of the measures taken. ResultsAwareness rate of medical waste-related knowledge among medical staff (2012:55.59%, 2013:62.89%, 2014:94.43%) increased with statistical significance (χ2=410.871, P<0.001). Accuracy rate of medical waste disposal (2012:69.83%, 2013:87.29%, 2014:94.91%) increased with statistical significance (χ2=197.449, P<0.001). Rank correlation analysis showed that average daily medical waste amount declined as average daily inpatients number increased (rs=?0.590, P<0.001). ConclusionUsing PDCA cycle can improve the awareness rate of medical waste-related knowledge and accuracy among medical staff to achieve continuous quality improvement of medical waste management.