By research on the universal standards classification of medical device, according to their functions and scope of application, they are divided into two levels, universal standard architecture is proposed, to provide opinions and suggestions for standard system construction of medical devices.
Equipment and Supplies ; standards ; Humans

It was found that several problems exist in the implementation of GB 7544-2004 in the aspects of requirements of natural latex materials and safety of rubber condom products, microorganisms to be controlled and the packaging and label. As a result, the suggestions were put forward.
Condoms ; standards ; Latex ; Materials Testing ; standards ; Rubber

This paper analyzes the recently epidemic status of schistosomiasis,the change of natural and social factors,and field survey and evaluation data of schistosomiasis in Ya’an City after Lushan Earthquake on April 20,2013,and proposes that it is necessary to strengthen the conventional schistosomiasis control measures,the control of exogenous infection sources,the con-trol of Oncomelania hupensis snails and health education for ensuring no major epidemics after the disaster. This paper also recom-mends the direction and suggestions for future schistosomiasis control in Ya’an City.

Objective To systematically evaluate the application effect of the quality control circle(QCC)in the complications after PICC catheterization.Methods The randomized controlled trials(RCTs)on the application effect of QCC after PICC catheter-ization were retrieved from the Cochane library,PubMed,EMBASE,Chinese Biomedical literature Database(CBM),China Academic Journal Full-text Database(CNKI),VIP and Wangfang Database by computer.The literatures were selected according to the inclu-sion and exclusion criteria.The two valuators independently retrieved and screened the literatures,extracted the data,evaluated the methodological quality of included literatures and conducted the cross check.Then the meta analysis was performed by using Rev-Man 5.3 software.Results A total of 7 914 articles were retrieved,finally 14 RCTs were included,involving 2 728 patients.The oc-currence rates of phlebitis,catheter obstruction,unplanned extubation and catheter-related blood flow infection in the intervention group were lower than those in the control group,the difference was statistically significant(OR=0.28,95% CI:0.16-0.48,P<0.01;OR=0.27,95% CI:0.17-0.42,P<0.01,OR=0.27,95% CI:0.18 -0.39,P<0.01;OR=0.25,95% CI:0.13 -0.49,P<0.01).Conclusion Using QCC is conducive to reduce the complication incidence rate after PICC catheterization.

ObjectiveTo explore the clinical efficacy of Gouteng prescription in treating the patients with primary hypertension with anxiety disorder due to yang hyperactivity and heat toxin and the impact of the formula on the balance of inflammatory cytokines. MethodA total of 98 patients diagnosed with primary hypertension and anxiety disorder were randomized into control and observation groups. On the basis of conventional western medicine treatment for hypertension， the control group （47 patients） was treated with Shugan Jieyu capsules for 8 weeks， while the treatment group （51 patients） with Gouteng prescription for 8 weeks. The two groups were compared in terms of the blood pressure level， 24-hour blood pressure variability， Hamilton anxiety scale （HAMA） score， Pittsburgh sleep quality index （PSQI） score， quality of life （SF-36 scale） score， traditional Chinese medicine （TCM） syndrome score and efficacy， incidence of adverse reactions， and the levels of interleukin （IL）-1β， IL-6， IL-10， and IL-4 in the serum of peripheral blood. ResultThe final trial was completed with 95 patients， including 46 in the control group and 49 in the observation group. The treatment in both groups lowered the blood pressure and blood pressure variability （P<0.05， P<0.01）. The observation group outperformed the control group in recovering the systolic blood pressure （SBP）， 24-hour mean systolic blood pressure （24 h SBP）， 24-hour systolic blood pressure variability （24 h SBPV）， and 24-hour diastolic blood pressure variability （24 h DBPV） （P<0.05）. After treatment， the HAMA and PSQI scores in both groups decreased （P<0.05， P<0.01）， and the observation group had lower HAMA and PSQI scores than the control group （P<0.05）. Compared with those before treatment， the SF-36 scores in both groups increased （P<0.05， P<0.01）. After treatment， the observation group had higher scores of physiological function （PF）， bodily pain （BP）， social function （SF）， role-emotional （RE）， and mental health （MH） indicators than the control group （P<0.05）. After treatment， the TCM syndrome scores in both groups decreased （P<0.05， P<0.01）， and the observation group had lower score than the control group （P<0.05）. The total response rate regarding TCM syndrome in the observation group was 85.71% （42/49）， which was higher than that （63.04%， 29/46） in the control group （χ²=6.621， P<0.05）. The treatment in both groups lowered the levels of pro-inflammatory cytokines （IL-1β， IL-6） and elevated the levels of anti-inflammatory cytokines （IL-10， IL-4） （P<0.05， P<0.01）， and the changes were more obvious in the observation group than in the control group （P<0.05）. There were no adverse events during the research process. ConclusionGouteng prescription can recover the blood pressure level， reduce blood pressure variability， suppress anxiety state， improve sleep and quality of life， decrease TCM syndrome score， increase total response rate， lower serum IL-1β and IL-6 levels， and elevate serum IL-10 and IL-4 levels in the patients with primary hypertension complicated with anxiety disorder due to yang hyperactivity and heat toxin. It may exert the effects by regulating the balance of pro-inflammatory and anti-inflammatory cytokines.