Objective To study the USA government’s administrative system about medical device standards as well as the standard making. Methods The relevant documents, regulations, website that USA Food and Drug Administration announced were extensively reviewed, knowing the USA medical device standards synthetically. Results The USA standards system of medical device included regulatory requirements and voluntary consensus standards. This article simply introduced the laws, regulations, performance standards and consensus standards. Conclusion The USA’s administrative system about medical device standards as well as many standards can be referenced.
In November 2018, the American Heart Association (AHA) updated Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Rather than a comprehensive revision of the 2015 edition guidelines, the 2018 AHA guidelines update was updated again according to the rule " the update of the guideline is whenever new evidence is available”, providing the evidence review and treatment recommendation for antiarrhythmic drug therapy in pediatric shock-refractory ventricular fibrillation/pulseless ventricular tachycardia cardiac arrest. The Pediatric Task Force of the International Liaison Committee on Resuscitation updated the guideline, reaffirming the 2015 pediatric advanced life support guideline recommendation that either lidocaine or amiodarone may be used to treat pediatric patients with shock-refractory ventricular fibrillation or pulseless ventricular tachycardia.
ObjectiveTo establish a sound management system for day surgery under the Joint Commission International (JCI) standard.MethodsFrom 2013, according to the provisions of JCI standard, a sound management system was established in the Second Affiliated Hospital of Zhejiang University School of Medicine by establishing the organizational structure of day surgery management, standardizing the operation process of day surgery, formulating standard operating rules and regulations, clarifying work responsibilities, strengthening the supervision of medical quality indicators at both hospital and department levels, and providing guidance for continuous performance.ResultsThe number of day operations in the hospital increased gradually, accounting for 25% of elective operations. During this period, there was no death of the patient, and these indexes remained low: the reservation cancellation rate of the patient was 0.9%, the transfer hospitalization rate was 0.23%, the unplanned reoperation rate was 0.012%, and the postoperative serious complications (bleeding, wound opening, etc.) was 0.03%.ConclusionThe establishment of day surgery management system under the JCI standard can standardize the development of day surgery and ensure the safety of patients.
【摘要】 目的 对脑梗死患者施行静脉溶栓治疗前后的相关状况和指标进行评价分析。 方法 2003年1月-2010年11月对神经内科收治的29例脑梗死患者予以静脉溶栓治疗及护理，并就治疗前后各相关时间点血压监测及美国国立卫生研究院卒中量表（National Institute of Health stroke scale，NIHSS）评分情况进行分析。 结果 溶栓前后血压对比显示:溶栓后2 h收缩压相对于溶栓前和溶栓后24 h升高（Plt;0.05）；溶栓前后NIHSS评分差异有统计学意义（Plt;0.05）。 结论 溶栓后患者收缩压出现升高，护理上应该加强血压监控，为临床治疗提供支持。【Abstract】 Objective To investigate the correlated condition and clinical index changes before and after the intravenous thrombolysis of the cerebral infarction patients. Methods The blood pressure and the National Institutes of Health stroke scale (NIHSS) score of 29 cerebral infarction patients with the intravenous thrombolysis treatment between January 2003 and November 2010 were measured and analyzed. Results Two hours after the thrombolysis, the systolic blood pressure significantly increased compared with those before the intravenous thrombolysis and 24 hours after intravenous thrombolysis （P＜0.05）. NIHSS score was significantly decreased after the thrombolysis （P＜0.05）. Conclusions Systolic blood pressure significantly increases after the intravenous thrombolysis. Intensive blood pressure monitoring and controlling may be beneficial to the treatment and prognosis.
American Heart Association (AHA) updated the advanced cardiovascular life support use of antiarrhythmic drugs during and immediately after cardiac arrest in the AHA guidelines for cardiopulmonary resuscitation and emergency cardiovascular care in November 2018. Based on the latest progress of relative evidence-based clinical evidence and 2015 AHA guidelines for cardiopulmonary resuscitation and cardiovascular emergency cardiovascular care. This update gave recommends on the use of antiarrhythmic drugs during resuscitation from adult shock-refractory ventricular fibrillation (VF) and pulseless ventricular tachycardia (pVT) cardiac arrest and immediately after restoration of spontaneous circulation following shock-refractory VF/pVT cardiac arrest, respectively. This review aims to interpret this update by reviewing the literature and comparing the recommends in this update with other guidelines.
ObjectiveTo explore the pathogenesis of tuberculosis and provide new ideas for its early diagnosis and treatment.MethodsGSE54992 gene expression profile was obtained from the gene expression database. Differentially expressed genes (DEGs) were screened using National Center forBiotechnology Information platform, and GO enrichment analysis, pathway analysis, pathway network analysis, gene network analysis, and co-expression analysis were performed to analyze the DEGs.ResultsCompared with the control group, a total of 3 492 genes were differentially expressed in tuberculosis. Among them, 1 686 genes were up-regulated and 1 806 genes were down-regulated. DEGs mainly involved small molecule metabolic processes, signal transduction, immune response, inflammatory response, and innate immune response. Pathway analysis revealed chemokine signaling pathway, tuberculosis, NF-Kappa B signaling pathway, cytokine-cytokine receptor interaction, and so on; gene signal network analysis found that the core genes were AKT3, PLCB1, MAPK8, and NFKB1; co-expression network analysis speculated that the core genes were PYCARD, TNFSF13, PHPT1, COMT, and GSTK1.ConclusionsAKT3, PYCARD, IRG1, CD36 and other genes and their related biological processes may be important participants in the occurrence and development of tuberculosis. Bioinformatics can help us to comprehensively study the mechanism of disease occurrence, which can provide potential targets for the diagnosis and treatment of tuberculosis.
Objective To develop and validate a prediction model to assess the risk of depression in patients with chronic kidney disease (CKD) based on National Health and Nutrition Examination Survey (NHANES) database. Methods Data on patients with CKD were selected from the NHANES between 2005 and 2018. Participants were randomly divided into a training set and a validation set in a 7∶3 ratio for model development and validation, respectively. Multivariable logistic regression was used in the training set to identify independent risk factors associated with depression in CKD patients, with stepwise selection applied to determine the final predictors. Model performance was assessed using receiver operating characteristic curve (ROC), calibration plots, and decision curve analysis (DCA). Internal validation was performed through bootstrap resampling, and a predictive model was ultimately established. Results A total of 4413 CKD patients were included, including 2112 males (47.86%) and 2301 females (52.14%). Among them, 3089 patients were assigned to the training set and 1324 to the validation set. In the training set, 332 patients (10.75%) presented with depressive symptoms, while 143 patients (10.80%) in the validation set had depressive symptoms. Multivariate logistic regression analysis showed that other hispanic, current smoking, and sleep disorders were risk factors (P＜0.05). Male, middle or high-income, high school grad/ged or above, married or widowed were protective factors (P＜0.05). Finally, 7 variables were included to construct a prediction model, including gender, poverty income ratio, education level, marital status, smoking status, body mass index, and sleep disorders. The ROC curve showed that the AUC=0.773 [95% confidence interval (0.747, 0.799)] in the training set, the internal validation was evaluated by 1000 Bootstrap resampling methods, and the corrected C-index=0.763. The validation set AUC=0.778 [95% confidence interval (0.740, 0.815)], showed good discrimination ability. The calibration curve showed that the model’s predicted probability was highly consistent with the actual occurrence. Decision curve analysis showed that the model provided a significant net benefit for clinical decision-making at a threshold probability of 20%～50%. Conclusions The prediction model constructed in this study can effectively predict the risk of depression in patients with CKD and can provide guidance for early screening and personalized intervention for high-risk groups. However, the external validation and localization of the model still needed further research.
Surgical management of osteoarthritis of the knee: evidence based guideline contains 38 recommendations pertaining to the preoperative, perioperative, and postoperative care of patients with knee osteoarthritis (KOA) who are considering surgical treatment. Compared with the domestic consensus on diagnosis and treatment for KOA, this clinical practice guideline (CPG) prepared by the American Academy of Orthopedic Surgeons (AAOS) has some advantages in terms of methodology selection and recommendation. Therefore, it is necessary for us to interpret this CPG to speed up the understanding and dissemination of the CPG. The ultimate aims are to: ① strengthen the standardization and understanding of surgical treatment of KOA; ② enhance the understanding of clinicians for this CPG in treating KOA; ③ speed up the development of guideline development methodologies in China; ④ provide methodological guidance for the development of CPG based on the current situation in China.
Objective To evaluate evidence from American medical risk monitoring and precaution system (AMRMPS) which may affect the construction of Chinese medical risk monitoring and precaution system (CMRMPS). Methods We searched relevant databases and Internet resources to identify literature on AMRMPS, medical errors, and patient safety. We used the quality evaluation system for medical risk management literature to extract and evaluate data. Results In 1999, a report from the Institute of Medicine (IOM) not only showed the severity and cause of medical errors in America but also gave the solution of it. In 2000, the Quality Interagency Coordination Task Force (QuIC) was appointed to assess the IOM report and take specific steps to improve AMRMPS. After 5 years, a well-developed medical risk management system was established with the improvement in the public awareness of medical errors, patient safety, performance criteria of medical safety, information technology and error reporting system. There was still some weakness of this system in risk precaution and prevention. Conclusion The experience from AMRMPS can be used to establish the CMRMPS. Firstly, we should disseminate and strengthen the awareness of medical risk and patient safety in public. Secondly, we should establish hospital audit system which includes auditing of medical staff and course of medical risk in continuing and academic education. Thirdly, we should develop regulations and guidelines on health care, medical purchase and drug supply which will benefit in management of regular work. Fourthly, we should develop computer information system for hospital which will regulate the management without the disturbance from human. Lastly, we should emphasize outcome evaluations and strive for perfection during the process.