This article analyzes the status quo of sales supervision on medical devices through some aspects, including the relevant regulation system, the standards of sales admittance, the supervision team and the approval of business license. According to the exiting problems, some improving countermeasures are proposed for reference.
Materials Management, Hospital ; organization & administration

This paper focuses on issues needed to be clear towards the product quality supervision of medical devices in use. The life circle of medical devices, the supervision regarding its boundary, target, emphasis, basis and standards have been analyzed in turn. A clear and creative idea is also provided for theoretical exploration of the supervision on medical devices in use.
Materials Management, Hospital ; Quality Assurance, Health Care

Actins ; metabolism ; Adult ; Breast Neoplasms ; metabolism ; pathology ; surgery ; Calcium-Binding Proteins ; metabolism ; Cell Differentiation ; Desmin ; metabolism ; Diagnosis, Differential ; Female ; Fibroadenoma ; metabolism ; pathology ; surgery ; Hamartoma ; pathology ; Humans ; Hyperplasia ; Leiomyoma ; pathology ; Microfilament Proteins ; metabolism ; Muscle, Smooth ; pathology ; Phyllodes Tumor ; pathology

This paper focused on the revision of national administrative provisions for the sampling and testing of quality supervision on medical devices, according to the practice, it introduced the scope of application, Chinese system of sampling and testing on medical devices, the methods of sampling, inspection standards, re-inspection institutes and the other issues should be taken into consided and discussed. The current situation of these issues, main idea of the revision and influences of the provisions were also analyzed to provide theoretical exploration for the revision.

In this paper, we analyze the status of the medical device testing and the situation of the unqualifie varieties by sorting out the situation of the national medical device supervision and inspection from 2013 to 2016. We analyze the results of the inspection deeply, and find that the safety risk points exists in the quality of the medical device testing products and management system, product technology requirements, the national standards, industry standards or other aspects, then explain one by one with typical examples. At the same time the corresponding suggestions are put forward to production companies and regulators respectively on the existing problems.

Adenocarcinoma ; metabolism ; pathology ; surgery ; Cardia ; Esophageal Neoplasms ; metabolism ; pathology ; surgery ; Esophagogastric Junction ; metabolism ; pathology ; surgery ; Humans ; Neoplasm Staging ; Receptor, ErbB-2 ; metabolism ; Sirtuin 1 ; metabolism ; Stomach Neoplasms ; metabolism ; pathology ; surgery ; Survival Rate

The influencing factors on cord blood storage after collection and mononuclear cell separation as well as cryopreservation were studied. The mononuclear cell are separated from blood after blood collection, then cryopreserved and washed after thawed. Results showed that the cord blood kept at 4 degrees C or room temperature less than 24 hours after blood collection, mononuclear cell separated by hydroxyethylstarch and 2 centrifugations, mononuclear cell cryopreserved with 50% DMSO and autoplasma from cord blood as protectives and washing the cells after thawing. In conclusion, the optimal project in this study can effectively preserve cord blood mononuclear cells.
Blood Preservation ; Cell Separation ; methods ; Cryopreservation ; Fetal Blood ; cytology ; Humans ; Leukocytes, Mononuclear ; physiology

OBJECTIVESyncope is a common problem in children and adolescents. Such an event may have multiple possible causes, ranging from benign conditions to life-threatening diseases. Syncope is a major challenge for the practicing physicians. It is very important to know the etiologic and clinical characteristics of syncope in children. This study aimed to improve diagnostic efficacy of syncope in children by analyzing the etiology and clinical characteristics of syncope.

METHODSThe investigators retrospectively analyzed the causes of syncope and diagnostic workup of 154 consecutive children seen in Department of Pediatrics, Peking University First Hospital because of a syncopal event.

RESULTSAutonomic-mediated reflex syncope (AMS) was the most common cause of syncope (65.6%), whereas cardiac disorders were found in 10 cases (6.5%) comprising the second cause of syncope in children. Other causes included psychologic problems and neurological and metabolic disorders. Although many causes were studied, 25 cases (16.2%) were found to have uncertain etiologies yet. The children with AMS were commonly seen in pubertal girls, and they had clear inducement of syncope and prodromes. The children with cardiac syncope often had history of cardiac diseases, and they were often younger than those with AMS. Lack of prodromes of syncope, exercise-related syncope, syncope spells seen in any body position, frequent syncope spells and sudden death in family were clues of cardiac syncope. Neurological disorders should be considered if there are any of the followings: syncope with seizure activity, syncope spells seen in any position, and a postictal phase of disorientation or neurologic abnormal signs. A metabolic cause was entertained when the child had a history of metabolic diseases, prolonged anger, or violent vomiting and diarrhea. Children with psychiatric disorders were adolescent girls with prolonged syncope spells, and had more frequent syncopal episodes. Most children with syncope were evaluated by many of diagnostic tests, but most of those tests were not goal-directed approach. Since persons with cardiac syncope were at increased risk for death from any cause, electrocardiography was recommended in almost all children with syncope. Neurologic testing including electroencephalography, computed tomography, etc. were rarely helpful unless neurologic signs and symptoms are present. Holter electrocardiography and echocardiography were most useful in children with suspected cardiac syncope. There was little benefit of screening cardiac enzyme in children with syncope. Routine blood tests (blood electrolytes and blood glucose, etc) rarely yield diagnostically useful information unless the children had the history of metabolic diseases. Head-up tilt testing was most useful in children with recurrent syncope in whom heart disease was not suspected. The children with frequent syncope, long lasting syncopal episode and clear psychiatric inducement of syncope should be evaluated by psychiatric testing.

CONCLUSIONSyncope in children may result from a wide variety of causes, and clinicians often use a wide range of investigation to try to achieve a diagnosis. But most of investigations have low diagnostic yield. Thorough history taking, physical examination and electrocardiography are the core of the syncope workup.

Adolescent ; Child ; Child, Preschool ; Electrocardiography ; Female ; Humans ; Male ; Retrospective Studies ; Syncope ; diagnosis ; etiology

This paper introduces the sampling scheme and the inspection scheme paradigm followed in organizing the sampling inspection of medical devices. The sampling scheme paradigm includes the definition and operation guidelines for sampling products, the regulations for individual sampling batches and related model specifications, accessory data, validity period, storage conditions, etc., the requirements for sampling areas, places and quantities, and the requirements for samples to be sent to inspection institutions. The inspection scheme paradigm includes the provisions for inspection basis, inspection items and determination principles.
Equipment Safety ; methods ; Guidelines as Topic

Objective:To identify Down syndrome (DS) fetal encephalopathy related genes and signaling pathways via bioinformatics analysis, and to explore their potential mechanisms underlying the occurrence and development of DS neuropathology.Methods:Retrospective study.In December 2021, dataset GSE59630 was downloaded from the gene expression omnibus (GEO), and differentially expressed genes (DEGs) between DS and normal fetal brain tissue were identified by R software.Gene Ontology (GO), Kyoto Encyclopedia of Genes and Genomes (KEGG) enrichment analysis and gene set enrichment analysis (GSEA) were performed on the genes identified.The protein-protein interaction (PPI) network was constructed based on search tool for the retrieval of interacting genes online database and Cytoscape software, and key modules and hub DEGs were identified.Real-time quantitative polymerase chain reaction technique was used to verify the expression of hub genes related to neurodegeneration in brain tissue of 3 pairs of DS and normal fetuses at the gestational age of 22-33 weeks.Results:A total of 225 DEGs were screened out from DS and normal fetal brain tissue, including 18 up-regulated genes and 207 down-regulated genes.GO functional enrichment analysis showed that DEGs were mainly enriched in neurogenesis, neuronal apoptosis, transcriptional regulation, mitochondrial energy metabolism, etc.KEGG pathway enrichment analysis revealed that DEGs were associated with a variety of neurodegenerative diseases.GSEA suggested that apoptosis and inflammatory responses play a vital part in the occurrence of DS neuropathology.Ten hub genes were identified by the PPI network established, and they were mainly related to histone acetylation and transcriptional regulation.According to the tissue verification result, the variations of RAB8A, TBP and TAF6 expression conformed to the microarray data. Conclusions:The key genes and signaling pathways identified by transcriptome analysis of fetal brain tissue facilitate the comprehensive understanding of the molecular mechanism of DS neuropathology.This study provides a novel insight into the clinical diagnosis and treatment of neurodevelopmental abnormalities and mental retardation in DS.