The article has summarized the situation related to medical device naming, analyzed the problems of medical device naming in our country, put forward some new thinking in building the naming system of medical device in our country provided some reference on technical study of medical device naming.
China ; Durable Medical Equipment ; classification ; Terminology as Topic

The article has reviewed the administration technical structure and global application of the global medical device nomenclature(GMDN), analyzed the coordination between GMDN and the industry status of medical device in our country, put forward some suggestions on the applicaition of GMDN, provided some reference on raising the management level of medical device in our country.
Equipment and Supplies ; standards ; Terminology as Topic

USA is the first country implementing the UDI program at national level,and the UDI rules and GUDID guidance have been issued by FDA recently to officially launch the implementation of UDI. The paper reviewed the advancement of UDI program,dis-cussed the framework of UDI system,analyzed the approaches of UDI implementation such as accredited issuing agencies and GUDID et al, and made some suggestions on the development of medical device coding system in our country.

Objective To investigate the changes of soluble CD105,transforming growth factor-beta1(TGF-β1) and vascular endothelial growth factor(VEGF) in esophageal cancer(EC) patients,analyzing its clinical significance.Methods Collecting 56 cases of gastric cancer(observation group) and 49 cases of healthy people(control group)from Nov.2014 to Jan.2016 as the research objects.The levels of soluble CD105,TGF-β1 and VEGF were detected in EC patients pre-and post-operation and healthy subjects.The data of soluble CD105,TGF-β1 and VEGF were analyzed in the two groups.Results The pre-operation levels of soluble CD105,TGF-β1 and VEGF in EC patients were significantly higher than those in the control group,the difference was statistically significant(P<0.05).The pre-operation levels of soluble CD105,TGF-β1 and VEGF in EC patients were significantly higher than post-operation levels,the difference was statistically significant(P<0.05).The post-operation levels of soluble CD105,TGF-β1 and VEGF in EC patients were not statistically different with control group(P>0.05).Conclusion The levels of soluble CD105,TGF-β1 and VEGF could be abnormal in patients with EC,which might be the index for monitoring the clinical disease condition and judging the prognosis of the EC.

The article has analyzed the policy co-ordination, Industry coverage and technical experience of the global medical device nomenclature (GMDN) to our country, argued the feasibility on the application of GMDN in our medical device administration system, provided some reference on building the naming system of medical device in our country.
Equipment and Supplies ; Feasibility Studies ; Industry ; Terminology as Topic

Unique Device Identification (UDI) is a hot spot research area in the medical device administration. It comes a breakthrough from International Medical Device Regulators Forum (IMDRF) and government implementation recently. The article reviewed the advancement of IMDRF UDI program, discussed the framework for UDI system, analyzed the implementation of UDI in other countries, put forward some suggestions on the development of medical device coding system in our country.
Equipment and Supplies ; standards ; Product Labeling ; standards

By scattered-sampling testing the disposable sterilized syringe according to legal inspection and explorative research methods of vitro cytotoxicity and easy oxide etc. testing, this article comprehensively evaluated and analyzed the product quality and found the potential risk. The results will help to improve the work process and product quality.
Disposable Equipment ; Product Surveillance, Postmarketing ; Quality Control ; Syringes

Objective : To detect the composition of the subgingival microbiota in generalized aggressive periodontitis (GAgP) and severe chronic periodontitis (SCP) patients tested by high-throughput sequencing (HTS) technologies, analyze its diversity and function by using bioinformatics, and observe changes in the subgingival microbiota before and after periodontal initial therapy. Methods: Eleven patients with GAgP and 14 patients with SCP who visited the Department of Periodontics in Stomatological Hospital of Kunming Medical University from September 2018 to May 2019 were recruited, and subgingival plaque samples were collected at baseline and 6 weeks after initial therapy. Then, the genomic DNA was distracted and sequenced by the Illumina MiSeq high-throughput sequencing platform. QIIME (quantitative insights in microbial ecology), Mothur, SPSS and other software were used to analyze community information. LEfSe difference analysis (linear discriminant analysis effect size), network analysis, and the KEGG PATHWAY database (https://www.kegg.jp/kegg/pathway.html) were used to predict community function. Results : At baseline, the dominant microbiota of GAgP and SCP patients were similar, including Bacteroidetes, Porphyromonas and Porphyromonas endodontalis. Six weeks after initial therapy, as the periodontal pocket became shallower, the variation trend of the microbiota of GAgP and SCP patients was similar. The relative abundance of gram-negative bacteria, such as Bacteroidetes, Porphyromonas and Porphyromonas endodontalis, decreased, while the relative abundance of gram-positive bacteria, such as Proteobacteria, Actinomyces and Rothia aeria, increased. Actinobacteria were significantly increased biomarkers of the subgingival microbiota in GAgP after treatment. Streptococcus is an important genus that connects the microbiota related to periodontitis and the microbiota related to periodontal health. Community function prediction result showed that initial treatment can reduce the functions of amino acid metabolism, methane metabolism, and peptidase in GAgP and SCP patients. Conclusion The subgingival microbiota of GAgP and SCP patients are similar. Streptococcus, as an early colonizer, may play an important role in promoting plaque biofilm formation and maturation in the process of subgingival flora from health to imbalance. Initial therapy can change the composition and structure of the subgingival microbiota, reduce community diversity, and reduce the functions of amino acid metabolism, methane metabolism, and peptidase in GAgP and SCP patients.

Objective: To understand the occurrence and predictive factors of depressive symptoms among multi ethnic middle school students in Yunnan Province, so as to provide a referential framework for schools to carry out targeted mental health education. Methods: From October to December 2022, 8 500 first grade students from 23 middle schools were selected from 11 minority areas in Yunnan Province by cluster random sampling method. Demographic information and data relating to the students lifestyles were collected by questionnaire, and the Children s Depression Inventory (CDI) was used to evaluate depressive symptoms. Chi square test was performed to compare differences in the detection rate of depressive symptoms among first grade middle school students for univariate analysis. A decision tree model of depressive symptoms in middle school students was established by using the Chi squared automatic interaction detector (CHAID). Results: The detection rate of depressive symptoms among first grade students from multi ethnic middle schools in Yunnan Province was 28.26%. The decision tree model of depressive symptoms was academic stress ( χ 2=469.08) at the first level, breakfast behaviors (low/moderate academic stress: χ 2=155.49; severe academic stress: χ 2=105.24) at the second level, and the number of close friends (low/moderate academic stress and consuming breakfast 0- 2 days weekly: χ 2=23.15; low/moderate academic stress and consuming breakfast 3-4 days weekly: χ 2=14.99; severe academic stress and consuming breakfast 0-2 days weekly: χ 2=29.26; severe academic stress and consuming breakfast 3-4 days weekly: χ 2=20.15), ethnicity ( χ 2=78.22) and drinking ( χ 2=50.36) at the third level ( P <0.01). Conclusions The study identifies academic stress, breakfast behaviors, number of close friends, drinking and ethnicity as predictive factors of depressive symptoms among multi ethnic middle school students in Yunnan Province. Schools should develop targeted strategies for preventing and managing depressive symptoms in middle school students, so as to reduce their occurrence.

Objective: To determine the latent class of dietary patterns and their association with depressive symptoms among first grade students from multi ethnic middle schools in Yunnan Province, so as to provide a reference basis for promoting mental health among border middle school students. Methods: A cluster random sampling involving 8 500 first grade middle school students from 11 counties in Yunnan Province was conducted by a questionnaire survey between October to December 2022. The Children s Depression Inventory (CDI) was used to assess the depressive symptoms and the Food Frequency Questionnaire was used to collect eating behavior data. The latent profile analysis model was used to fit the latent class of dietary patterns among students. The association between the dietary pattern latent class and depressive symptoms was analyzed by Logistic regression. Results: The depressive symptom detection rate among firstgrade middle school students was 28.3%. Prevalence of depressive symptom in girls (30.9%) was higher than boys (25.5%) with a statistically significant difference ( χ 2=29.83, P <0.01). The dietary patterns among first grade middle school students were classified into four latent classes, as follows:class 1 (low consumption of all dietary components), class 2 (high consumption of fruit, milk and dairy products), class 3 (high consumption of vegetables and meat, and low consumption of processed foods) and class 4 (low consumption of milk, dairy products and eggs, and high consumption of processed foods). After adjusting for confounding variables, the class 3 dietary pattern was negatively correlated with depressive symptoms ( OR=0.62, 95%CI =0.52-0.74) and the class 4 dietary pattern was positively correlated with depressive symptoms ( OR= 1.28 , 95%CI =1.05-1.57) ( P <0.05), compared with the class 1 dietary pattern. Conclusions Multi ethnic first grade middle school students in Yunnan Province follow various dietary patterns. Unhealthy dietary patterns increase the risk of depressive symptoms. The dietary patterns of multi ethnic middle school students in Yunnan Province should be adjusted to promote the establishment of healthy dietary patterns and reduce the risk of depression symptoms in middle school students.