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

Aim To observe the thickness changes of cardiomyocyte and microvascular basement membranes(BM)and the expression of collagen Ⅳ in Gk rats of different months and STZ-induced diabetic rats,and to explore the method that operated easily and could assess the thickness of myocardial BM.Methods GK rats of the fourth,fifth,sixth,seventh months,Streptozotocin induced diabetes rats of fifth months and normal Wister rats were respectively divided into different groups with ev eight rats in each group.The myocardial section was stained by methenamine silver and immunohistochemistry was performed for collagen Ⅳ.Left ventricular endocardium was selected as measuring view.Through computer image analysis,the ratio of BM positive staining density(BMPSD)and positive staining density of collagen Ⅳ(CPSD)were calculated separately in all myocardium.Take the ratio to assess the thickness of myocardial BM and the expression of collagen Ⅳ.Results The glycemia,BMPSD and CPSD of the two diabetes rats were higher than those of the normal rats,having highly remarkable difference(P0.05).Conclusion By methenamine silver staining for myocardial section,calculating BMPSD through computer image analysis,can be an index to assess the thickness of myocardial BM.

Objective To observe the preventative and curative effect of Tongxinluo on microvascular inflammatory injury and vasospasm in the cardiac muscle of streptozotocin (STZ) diabetic rats. Methods STZ rats were divided into STZ group, insulin group, Tongxinluo group, with the other 8 Wistar rats as normal control. The normal group and STZ group were intragastric administered with NS, insulin group was subcutaneous injected with insulin, and Tongxinluo group was intragastric administered with Tongxinluo suspension for 8 weeks. The sections of cardiac muscle was stained in HE staining and NF-?B immunohistochemical staining. The level of adhesion molecule-1 (sICAM-1), tumor necrosis factor (TNF-?), endothelin-1 (ET-1), angiotensin-Ⅱ (AT-Ⅱ) in myocardial homogenate from intercellular, and level of AT-Ⅱ, neuropeptide Y (NPY) in plasma were determined, with sICAM-1 by enzyme-linked immunosorbent assay and the others by radioimmunoassay. The sections stained by NF-?B immunohistochemical staining were image analyzed using computer. The extent of its expression was evaluated by the mean of the density ratio of the positive side. Results Compared with normal rats, the content of sICAM-1, TNF-?, ET-1, AT-Ⅱ and the expression of NF-?B in the myocardial homogenate of STZ rats was increased (P0.05). AT-Ⅱ in plasma of STZ rats increased (P

Objective:To analyze the epidemiological characteristics of human immunodeficiency virus (HIV) and hepatitis B virus (HBV) co-infected patients in Beijing and investigate the associated factors.Methods:The clinical data of patients with HIV infection who were treated in HIV/AIDS designated hospitals (Peking Union Medical College Hospital, Beijing Ditan Hospital and Beijing Youan Hospital) were retrospectively analyzed.Results:A total of 11 572 patients were finally included in the study, among whom 532 patients (4.6%) were co-infected with HIV and HBV. Most of the co-infected patients were young male adults (28~48 years old), accounting for 85.9%. The main transmission route was homosexual behavior (74.8%). There were 87.4% co-infected patients treated with two anti-HBV drugs, including lamivudine (3TC) and tenofovir (TDF). From 2013 to 2018, the annual prevalence of HIV and HBV co-infection decreased gradually, with the rate of 6.37%, 4.55%, 3.92%, 4.68%, 4.24% and 2.74%, respectively. In our study, The main influencing factors of HIV and HBV co-infection were age older than 28 years old versus<28 years old ( OR=2.807, 95% CI 1.241-6.345) and marriage status (married versus unmarried, OR=1.259, 95% CI 1.004-1.579). Conclusions:The proportion of HBV infection in HIV-infected patients is 4.60% (532) in our cohort. From 2013 to 2018, the prevalence of HIV and HBV co-infection in Beijing shows a decreasing trend. The risk of co-infection is higher in married young adults (28~48 years old).

Objective To investigate the efficacy and safety of oxcarbazepine combined with levetirac-etam on children with epilepsy. Methods According to different treatments, 62 cases of children with epilepsy were divided into the OXC group (treated with oxcarbazepine, 40 cases) and the OXC combined with LEV group (treated with oxcarbazepine and levetiracetam, 20 cases). Then the therapeutic efficacy, EEG changes and ad-verse reactions of patients in the two groups were studied. Results The total efficacy was 87.5% in the OXC group, and was 95.5% of the OXC combined with LEV group, with no significant difference. EEG improvement rate was 52.5% in the OXC group and 81.8% in the OXC combined with LEV group , with significant difference (P < 0.05). The rate of adverse reactions in the OXC combined with LEV group was lower than that in the OXC group (P < 0.05). Conclusion Both levetiracetam and oxcarbazepine has good curative effect on children with epilepsy , but combination with levetiracetam can significantly decrease the epileptic discharges on EEG , with higher security.

OBJECTIVE:To establish a method for the content determination of L-shikonin in Zilian liniment and evaluate the uncertainty by 2 calculation methods. METHODS:HPLC was performed on the column of Waters C18 with mobile phase of metha-nol-0.025 mol/L phosphate(85:15,V/V)at flow rate of 1.0 ml/min,the detection wavelength was 516 nm,column temperature was room temperature,and the injection volume was 10 μl. Quantitative analysis was conducted for the process and procedures calculat-ed by standard curve method and external standard method,and the uncertainty was evaluated. RESULTS:The linear range of L-shi-konin was 4.024-80.48μg/ml;RSDs of precision,stability and reproducibility test were lower than 2.0%;recovery was 88.5%-93.1%(RSD=2.0%,n=6). Standard curve method was used to determine the content,and the expanded uncertainty was 0.70 μg/ml;ex-ternal standard method was used to determine the content,and the expanded uncertainty was 0.30 μg/ml. CONCLUSIONS:Stan-dard curve method is more economical,more convenient and lower uncertainty in the content determination of L-shikonin in Zilian liniment.

Purpose:To study prognostic factors of younger women's eptihelial ovarian neoplasms.Methods: From Jan. 1980 to Dec. 1992, there were 86 cases of younger women's epithelial ovarian carcinoma in our hospital. We studied serveral prognostic factors retrospectively.Results:In this setting, 2 year survival rate were 79.07%, 5 year survival rate were 54.65%. There were 49 cases with stage Ⅰ and 41 cases with grade Ⅰ. No recurrence was found in 4 patients who preserved ovarian function. Cox model multifactor results showed that grade, residual tumor size and the method of surgery were prognostic factors( P 0 05). The pathological type, FIGO staging, grade, residual tumor size, the method of surgery were important factors according to unifactor analyze ( P

Objective To study the bacteriological effect of different dosages of gamma irradiation on Escherichia Coli (E. Coli) in red blood cells (RBC) products,and assess the appropriate dose of gamma irradiation. Methods Prepare RBC samples inoculated with(102-106)/ml of E. Coli. The contaminated RBCs were irradiated by 0 (as control),15,20,25,30 and 35Gy of gamma irradiation. E. Coli in the RBCs were tested on days 0,7, and 14 after irradiation. Results The quantities of E. Coli changed after irradiation. The RBCs inoculated with less than 103cfu/ml of E. Coli were completely sterilized by 25 Gy irradiation. Conclusion 25 Gy gamma irradiation can eradicate less than 103cfu/ml of E. Coli in the RBC products.

OBJECTIVE: To provide medical staff with medication information concerning compatibility of hospital injections.METHODS: Based on the "Junwei No.1" hospital information system,a database system comprising system maintenance,information maintenance and comprehensive inquiry that can provide information of compatibility of hospital injections was developed through setting up database and sorting the information of hospital injections.RESULTS & CONCLUSIONS: This system is characterized by low cost,high transferability,friendly user interface,flexible inquiry and convenient maintenance,and it can facilitate medical staff's convenient,quick and accurate mastering of the information of hospital injections so as to provide better service for the patients.