The license management of medical devices is an important part of production supervision, but there are some contradictions and confusion in the relevant legislation. The right way of resolve the plight is to distinguish correctly license application on the medical devices production for the first time, license change and license continuity, and then make the appropriate regulatory requirements.
China ; Durable Medical Equipment ; Licensure ; legislation & jurisprudence

Objective:To study the therapeutic value of Xueshuantong injection combined atorvastatin in patients with coronary heart disease (CHD)complicated diabetes mellitus (DM).Methods:A total of 100 CHD+DM patients, who were treated in our hospital from Jan 2012 to Jan 2014,were selected.According to random number method, they were randomly and equally divided into routine treatment group (including atorvastatin treatment)and Xue-shuantong combined atorvastatin group (combined treatment group).Clinical therapeutic effect,change of blood lipid level and safety were observed in two groups.Results:Total effective rate of combined treatment group was significantly higher than that of routine treatment group (96.0% vs.68.0%,P =0.032).Compared with routine treatment group,after treatment,there were significant reductions in levels of total cholesterol [(4.38 ± 0.50) mmol/L vs.(4.09±0.47)mmol/L],triglyceride [(2.23±0.35)mmol/L vs.(1.79±0.28)mmol/L]and low density lipoprotein cholesterol [(2.45±0.29)mmol/L vs.(2.23±0.28)mmol/L],and significant rise in level of high density lipoprotein cholesterol [(1.11 ±0.12)mmol/L vs.(1.37± 0.25)mmol/L]in combined treatment group,P <0.05 all.Incidence rate of adverse reaction was 6.0% and 4.0% in combined treatment group and rou-tine treatment group respectively,but there was no significant difference between two groups,P =0.436. Conclu-sion:Xueshuantong combined atorvastatin treatment can significantly improve blood lipid levels and raise clinical therapeutic effect in CHD+DM patients.

Human recombinant B type natriuretic peptide(hBNP) binds to receptor in the vasculature, kidney, and other organs to mimic the action of endogenous natriuretic peptides. Intravenous infusion of hBNP has been studied with acute decompensated heart failure. It causes potent, dose related vasodilation that is rapid in onset and sustained for the duration of drug infusion, reflected by decreases in systemic vascular resistance, systemic arterial pressure, pulmonary capillary wedge pressure, right atrial pressure, and mean pulmonary arterial pressure. Vasodilation occurs without a change in heart rate and is associated with increases in stroke volume and cardiac output. hBNP may promote diuresis because of a direct natriuretic action, increased cardiac output, and decreased aldosterone levels. For decompensated heart failure, hBNP improves symptoms and is well tolerated. The major adverse effect is dose related hypotension. As a new vasodilator, it should be valuable in treatment of patients hospitalized for decompensated heart failure.

Currently all military hospitals attach great importance to the management of state-owned assets.However,there still exist some problems,such as weak management consciousness,irregular assets disposing and loose connections between management and accounting.The author ventures some measures to strengthen management consciousness,organization establishment,accounting procedures and monitoring mechanism.

The full implementation of GMP for medical devices, which is an important step to improve quality management system of medical devices production, will have a positive impact on the quality management system of medical device. It will improve and promote the development of quality management system for medical device, by updating the idea and rebuilding the frame and optimizing the contents.
China ; Equipment and Supplies ; standards ; Quality Control

Objective To master the epidemic situation and control effect of schistosomiasis in Yugan County,Jiangxi Prov-ince. Methods The data of the schistosomiasis prevalence in human and cattle as well as Oncomelania hupensis snail status were collected and the change trends were analyzed in Yugan County from 2008 to 2012. Results The schistosome infection rates of residents in Yugan County have declined every year since 2008,and currently,the prevalence of schistosomiasis was at a low lev-el. No acute schistosomiasis case was found during the past 5 years. In 2012,the infection rate of bovine was above 1%in 88 en-demic villages,and the area with schistosome infected snails was 10 hm2. Conclusion In order to achieve the goal of schistosomi-asis transmission control in the whole county in 2015,the comprehensive control measures based on infection source control should be strengthened.

Objective To explore the diagnostic value of CT hypotonic colonography in carcinoma of colon.Methods A total of 55 cases who were diagnosed as ileus,abdomen mass or suspected colonic carcinoma clinically were undergone CT hypotonic clolonography in six years recently,in our hospital.Of them,CT data of 35 cases identified by pathology were analysed retrospectively.Results CT diagnosis was corresponded to the pathologic results in 34 cases .Of them,33 cases were colonic adenocarcinoma(1 case with intussusception of ileum-colon type),one case was abdominal multiple metastatic adenocarcinoma.One case with cecal inflammation and granulation tissues hyperplasia was misdiagnosed for colonic carcinoma by CT.21 of 35 cases were undergone colongraphy,of them,15 cases were diagnosed as colonic carcinoma,1 case was normal,colonographic failure occurred in one case and 4 cases were false negative.Conclusion Hypotonic water perfusion CT scan in the cases permitted under clinical condition(patient with ileus should be perfused with 3% meglumine diatrizoate) can display clearly the primary focus,the position and range of ileus,surrounding organ.It is more excellent than conventional CT and X-ray examination.

China has started to accept the overseas clinical trial data about drug and medical devices, and the data in accordance with the requirements can be used to register in China. To do this work well, we should consider four key dimensions: data acceptance principle, data quality and reliability, data evaluation usability and data international difference. Among them, the authenticity, integrity, accuracy and traceability of data are the main factors to determine the quality reliability of data. Receiving data from overseas clinical trials about drug and medical devices will be conducive to the establishment of international mutual recognition system for clinical trial data, and to enhance the importance of data management in domestic clinical trials, and to promote the formation of quality management system on clinical trial data.

Objective To explore the myogenic basis of the increased excitability and contractile activity in detrusor instability (DI) and investigate the differences of spontaneous contractions by ryanodine receptor (RyR) channels regulation in sarcoplasmic reticulum (SR) between DI and normal bladder muscle and of the RyR channels protein expression. Methods DI model was confirmed by filling cystometry from rats that underwent partial bladder outlet obstruction (BOO) about 8 weeks ago. Muscle strips were dissected from fresh bladder under microscope and the isometric tension in DI and normal strips were detected. The contractions were recorded in these strips exposed to some agents. SR microsome protein was obtained from DI and normal bladder muscle preparations and was used for Western blot analysis to determinate RyR channels expression. Results Treated with RyR channels blocker ryanodine , the contractile frequence significantly increased in normal strips, but not in DI muscle. Western blot analysis showed that RyR channels expression in DI muscle was significantly less than that in normal preparations. Conclusion RyR channels act a negative role in spontaneous contractile activity and the presumed mechanism may involve in Ca 2+ release of RyR channels which causes activation of Ca 2+ -dependent K + channels to decrease contractility. But this crosstalk mechanism is weaken in DI muscle, which provides a chance for spontaneous contractile overactivity.

Objective To investigate the effect of different doses of dexmedetomidine on the median effective concentration (EC50) of propofol required to prevent the response to Supreme laryngeal mask airway (LMA) insertion in aged patients.Methods ASA Ⅰ or Ⅱ patients of both sexes,aged ≥ 65 yr,with a body mass index of 20-28 kg/m2,undergoing knee operation under general anesthesia,were randomly divided into 3 groups:control group (group C),small dose dexmedetomidine group (group D1 ) and large dose dexmedetomidine group (group D2 ).Dexmedetomidine 0.4 and 0.8 μg/kg were infused intravenously over 10 min in groups D1 and D2 respectively,while group C received the equal volume of normal saline instead.Anesthesia was induced with target-controlled infusion of propofol.The initial target plasma concentration of propofol was set at 3.5,3.0 and 2.6 μg/ml in groups C,D1 and D2 respectively.Following equilibration between the plasma and effect-site concentration of propofol,LMA was inserted when BIS value was 50-60.EC50 was determined by up-and-down sequential trial.The target plasma concentration of propofol increased/decreased by 10％ in the next patient depending on whether or not the LMA insertion response occurred.Positive LMA insertion response was defined as body movement,comer of the mouth movement,biting LMA,bucking and/or wallowing during insertion.The EC50 and 95％ confidence interval (CI) of propofol required to prevent LMA insertion response were calculated with sequential method.Results EC50(95％ CI) of propofol was 3.57 μg/ml (2.91-3.87 μg/ml),3.09 μg/ml (2.66-3.53 μg/ml) and 2.62 μg/ml (2.30-3.15 μg/ml) in groups C,D1 and D2 respectively.EC50 was significantly lower in groups D1 and D2 than in group C,and in group D2 than in group D1 ( P ＜ 0.05 ).Conclusion Dexmedetomidine 0.4 and 0.8 μg/kg infused intravenously can reduce the EC50 of propofol required to prevent the response to Supreme LMA insertion in aged patients,and the effect of 0.8 μg/kg is more obvious.