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.
With the publication of a vast amount of clinical research on hepatocellular carcinoma (HCC), the American Association for the Study of Liver Diseases (AASLD), the National Comprehensive Cancer Network (NCCN), the American Society of Clinical Oncology (ASCO), and the National Health Commission of China have all updated their diagnostic and treatment guidelines for HCC. There are no differences in the definition of HCC risk populations among the AASLD 2023, NCCN 2024, and China Liver Cancer Staging and Treatment Guideline (CNLC) 2024. Notably, CNLC 2024 has updated its guidance on high-risk factors and prospective surveillance for HCC based on the characteristics of HCC patients in China. The four guidelines have seen significant updates in the areas of neoadjuvant and adjuvant therapies, local treatments, and systemic treatments for HCC. CNLC 2024 refines the indications for local treatment, improves systemic treatment, and introduces new first-line therapy, including camrelizumab combined with rivoceranib or tislelizumab. The second-line therapy nivolumab plus ipilimumab for advanced HCC are recommended by AASLD 2023, NCCN 2024, and ASCO 2024, which may become a new first-line therapeutic option for patients with advanced HCC. We compare and interpret these four guidelines in this paper.
The 2025 American Thyroid Association Guidelines for the Management of Differentiated Thyroid Cancer in Adults, supported centrally by evidence-based medical evidence, has introduced systematic updates to the diagnostic pathways, treatment regimens, and follow-up strategies for thyroid cancer. Its content not only covers multidisciplinary fields such as internal medicine, surgery, radiology, and pathology, but also fully incorporates perspectives from patient populations—further enhancing the alignment of the guidelines with clinical practice and achieving comprehensive coverage of the whole-course management for differentiated thyroid cancer. In the field of surgical management, the guidelines focus primarily on four core areas: the scientific definition of thyroid resection scope, the rational planning of lymph node dissection scope, the precise protection of the recurrent laryngeal nerve, and the whole-course preservation of parathyroid function. For these key aspects, the guideline has put forward specific and guiding recommendations based on rigorous evidence-based medical evidence and multidisciplinary team consensus. This article integrates the expert interpretation findings from the 2024 American Thyroid Association annual meeting, providing a prospective organization and summary of the key clinical practice points and basis for updates in its surgical management chapter.
In October 2020, the American Heart Association issued the 2020 edition of guidelines for cardiopulmonary resuscitation and cardiovascular first aid, which comprehensively revised cardiopulmonary resuscitation and emergency cardiovascular care guidelines related to adults, children, newborns, resuscitation education science and treatment system. According to the latest edition of International Liaison Committee on Resuscitation’s classes of recommendation and levels of evidence, relevant suggestions are put forward. This article interprets the main updated and revised content, including children’s basic and advanced life support and neonatal resuscitation, in order to better guide emergency personnel and improve the quality of cardiopulmonary resuscitation and cardiovascular first aid.
Objective To investigate the efficacy of systemic immune inflammation index (SII) at admission and National Institutes of Health Stroke Scale (NIHSS) score immediately after thrombolysis on evaluating the short-term prognosis of neurological function in patients with acute ischemic stroke (AIS) receiving intravenous thrombolysis. Methods Patients with AIS treated with intravenous thrombolysis in the Second People’s Hospital of Chengdu between March 2022 and March 2023 were retrospectively analyzed. The basic data of the patients, NIHSS score at emergency admission, NIHSS score immediately after thrombolysis, modified Rankin Scale (mRS) score 3 months after discharge, and laboratory data at admission were collected, and SII at admission was calculated. According to the mRS score 3 months after discharge, the patients were divided into the good prognosis group (mRS≤2) and the poor prognosis group (mRS>2). Multivariate logistic regression analysis was used to screen out the factors affecting the prognosis of patients, and the receiver operating characteristic curve was drawn to analyze the evaluation effect of SII at admission and NIHSS score immediately after thrombolysis on the poor prognosis of neurological function of patients in the short term. Results A total of 213 patients were enrolled, and the prognosis was poor in 88 patients. Multivariate logistic regression analysis showed that age, onset-to-needle time, uric acid at admission, SII at admission, fasting blood glucose after admission, and NIHSS score immediately after thrombolysis were independent risk factors for poor prognosis in AIS patients (P<0.05). The area under the receiver operating characteristic curve (AUC) of SII at admission for predicting poor prognosis was 0.715, the sensitivity was 55.7%, and the specificity was 84.0%. The AUC of NIHSS score immediately after thrombolysis for predicting poor prognosis of patients was 0.866, the sensitivity was 87.5%, and the specificity was 72.8%. The AUC of SII at admission combined with NIHSS score immediately after thrombolysis for predicting poor prognosis of patients was 0.875, the sensitivity was 84.1%, the specificity was 77.6%, the positive predictive value was 72.5%, and the negative predictive value was 87.4%. SII at admission was positively correlated with NIHSS score at emergency admission, NIHSS score immediately after thrombolysis, and mRS score 3 months after discharge (P<0.05). Conclusion SII at admission can predict the short-term prognosis of neurological function of patients with AIS after thrombolysis therapy, and the combination of SII at admission and NIHSS score immediately after thrombolysis can improve the prediction efficiency.
Hypertension is a strong risk factor for atherosclerotic cardiovascular disease (ASCVD), heart failure, and microvascular complications. Hypertension is common among patients with diabetes. Recently, the American Diabetes Association (ADA) published a new position statement which updated the assessment and treatment for hypertensive patients with diabetes. This interpretation is intended to help Chinese clinicians to understand the new ADA position statement.
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.
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.
In November 2019, the American Heart Association updated guidelines for cardiopulmonary resuscitation (CPR) and emergency cardiovascular care. This update is not a comprehensive revision of the 2015 version. The updates for children and newborns mainly include three aspects: ① Pediatric basic life support: A. It is recommended that emergency medical dispatch centers offer dispatcher-assisted CPR instructions for presumed pediatric cardiac arrest. B. It is recommended that emergency dispatchers provide CPR instructions for pediatric cardiac arrest when no bystander CPR is in progress. ② Pediatric advanced life support: A. The bag-mask ventilation is reasonable compared with advanced airway interventions (endotracheal intubation or supraglottic airway) in the management of children during out-of-hospital cardiac arrest (OHCA). B. The extracorporeal CPR may be considered for pediatric patients with cardiac diagnoses who have in-hospital cardiac arrest (IHCA) in settings with existing extracorporeal membrane oxygenation protocols, expertise, and equipment. C. Continuous measurement of core temperature during targeted temperature management is recommended; for infants or children between 24 hours and 18 years of age who remain comatose after OHCA or IHCA, targeted temperature management is recommened. ③ Neonatal resuscitation: A. In term and late-preterm newborns (≥35 weeks of gestation) receiving respiratory support at birth, the initial use of 21% oxygen is reasonable. B. One hundred percent oxygen should not be used to initiate resuscitation because it is associated with excess mortality. C. In preterm newborns (<35 weeks of gestation) receiving respiratory support at birth, it may be reasonable to begin with 21% to 30% oxygen.
The development and application of health decision support system (HDSS) in clinical service and health management is efficient in controlling health expenditure rising from overlapped examinations, and in reducing medical errors rising from insufficient decision-making support tools. Typical HDSS in America includes CPOE, MYCIN, QMR, NEDSS etc., which are mainly used in disease diagnosis and treatment, public health emergency management, hospital management, and health insurance management. The successful experiences accumulated in the development of the US health decision support system are worth referring to, such as, integration of management system, decision-makers and ICT, meeting the urgent needs of clinical service and health management, effective E-health construction, and rational development pathway from clinical decision support system to health management decision support system.