According to the registered product standards specification of medical devices, combined with the standard reviewing work, the common problems of standards during medical devices registration were analyzed and corresponding suggestions were proposed to standardize the standard of the registered product, accelerate the standardization and promote the industry standardized.
Device Approval ; Equipment and Supplies ; standards

For the existing measurement methods of residual voltage which can't turn the power off at peak voltage exactly and simultaneously display waveforms, a new residual voltage detection method is put forward in this paper. First, the zero point of the power supply is detected with zero cross detection circuit and is inputted to a single-chip microcomputer in the form of pulse signal. Secend, when the zero point delays to the peak voltage, the single-chip microcomputer sends control signal to power off the relay. At last, the waveform of the residual voltage is displayed on a principal computer or oscilloscope. The experimental results show that the device designed in this paper can turn the power off at peak voltage and is able to accurately display the voltage waveform immediately after power off and the standard deviation of the residual voltage is less than 0.2 V at exactly one second and later.
Electric Power Supplies ; Equipment Design ; Microcomputers ; Signal Processing, Computer-Assisted

Objective To study the effect of TGF?β1 gene therapy on the rat model of postpartum stress urinary incontinence and explore a novel non?operative treatment of this disease. Methods Two hundred and forty 6?month old SD female rats were used to prepare the model of postpartum stress urinary incontinence by vaginal dilation with a water sac. 148 rats from the 185 successfully prepared model rats were selected, and randomly divided into 5 groups: the TGF?β1 gene therapy, clentuterol treatment, electric stimulation therapy, injection of empty vector plasmid, and non?treated groups. In addition, 20 normal rats were selected as blank control group. Sneeze test and urodynamic test were conducted, the pelvic floor pubococcygeus muscle contractile force/muscle weight ratio was calculated, serum TGF?1 was detected by ELISA, and TGF?1 protein was detected by immunohistochemistry at 1, 21, 42 and 63 days after the treatment. Results At 21 days after treatment, all the maximum bladder capacity, leak point pressure, and urine or contractile force / muscle weight ratio of the TGF?β1 gene therapy group showed even better effects than those of the electrical stimulation group, but the differences were statistically not significant ( P>0?05 ) . Conclusions TGF?β1 gene therapy shows good therapeutic effect on the rat models of postpartum stress urinary incontinence, suggesting that TGF?β1 gene therapy may become a new type of non?surgical treatment for this disease.

Objective:To expound the effect of Kangxianyixin prescription on cardiocyte apoptosis and expression of Bax and Bcl-2 in rats with dilated cardiomyopathy. Methods:Wistar rats with dilated cardiomyopathy established by furazolidone were treated 8 weeks with Kangxianyixin prescription,to observe cardiocyte apoptosis and to measure Bax and Bcl-2 expression in rats. Results:(1) In comparison of cardiomyocyte apoptosis indexes in rats,when compared with model group,the results showed significant difference in the combined group of high dosage of Kangxianyixin prescription and captopril,the high dosage group,the low dosage group,the captopril group(P

AIM:To explore the mechanisms of Kangxian Yixin Extract(Radix Codonopsis,Radix Astragali,Poria,Rhizoma Atractylodis macrocephalae,Radix et Rhizoma Salviae miltiorrhizae,Rhizoma Chuanxiong,Flos Carthami,Radix Paeoniae rubra,Herba Lycopi,Herba Leonuri) on ventricular remodeling after dilated cardiomyopathy. METHODS: Ventricular remodeling model was induced by giving Furazolidone in wistar rats for 8 weeks and survival rats were divided into 5 groups(14 rats each group) after another 8 weeks,all the rats were killed.The effects of Kangxian Yixin Extract on typeⅠand type Ⅲ collagen gene expression were determined with SP and RT-PCR methods. RESULTS: Collagen TypeⅠand Ⅲ of model group was significantly higher than that of normal group(P0.05),while higher than that of the low dosage of group(P

Objective To investigate the relationship between antipituitary antibodies (APAs) and hypopituiarism following traumatic brain injury (TBI),as well as the severity of brain injury.Methods The study included 73 patients who suffered TBI 9 to 12 months ago and were diagnosed with hypopituitarism during the follow-up.Based on their Glasgow Coma Scale (GCS) on admission they were categorized into three groups:A (3-8),B (9-12) and C (13-15).Levels of plasma pituitary hormones (GH,TT,FT3 and FSH/LH) and APAs were measured in all patients with chemiluminescence assays and ELISA,respectively.Results Patients in group A had higher levels of APAs and lower levels of hormones compared with those in group B(P＜0.001) or group C(P＜0.001),while no significant difference was found between group B and group C for levels of either APAs (P＞0.05) or hormones (P＞0.05).Levels of APAs were negatively correlated with both GH (r=-0.64071,P＜0.001) and GCS (r=-0.50132,P＜0.001).Conclusion The present investigation provides preliminary evidence that APAs may be associated with the development of TBI-induced hypopituiarism.It suggests that the severity of hypopituiarism following TBI could be predicted by measuring the level of APAs.

In the present study, 89 porcine reproductive and respiratory syndrome virus (PRRSV) isolates in China during 2007 to 2012 were randomly selected from the GenBank genetic sequence database. Evolutionary characteristics of these isolates were analyzed based on the sequences of non-struc-tural protein 2 (Nsp2) and glycoprotein 5 (GP5). The genetic variations of the isolates were also compared with six representative strains. The results showed that a high degree of genetic diversity exists among the PRRSV population in China. Highly pathogenic PRRSV isolates, with a discon-tinuous deletion of a 30 amino acid residue in the Nsp2 region, remained the most dominant virus throughout 2007-2012 in China. Owing to the extensive use of representative vaccine strains, natu-ral recombination events occurred between strains. Three isolates-HH08, DY, and YN-2011-were more closely related to vaccine strains than the other isolates. Both YN-2011 and DY were the evolu-tionary products of recombination events between strains SP and CH-1R. The results of the present study provide useful information for the epidemiology of PRRSV as well as for vaccine development.

Objective To explore an anatomical basis for the medial plantar skin flaps and its clinical value of repairing heel defects. Methods The origin,branches,course and distribution of the medial plantar artery and the nerve of flaps were studied in 10 adult cadavers(20 legs).8 cases of homonymy and opposite side heel soft tissue defects with medial plantar skin flaps,aged 10-42 years.Free skin transplantation on the donors. Results The length of media plantar artery deep branch was (8.9±0.2)cm,gives off 3-5 cutaneous branches.Medial plantar nerve have 5-8 branches.it inchdes 3～5cutaneous branches distribute plantar skin and 2-4 plantar digital nerves distribute toes skin.The area of flaps was 4.0 cm×3.0 cm-6.0 cm×5.0 cm in the 8 flaps. 6 pedicle skin flaps were transfenrred to repair homonymy side heel soft tissue defects.2 opposite side heel soft tissue defects were repaired by 2 free flaps.All the flaps were survived. All patients were followed up one months to one year,the function and appearance of the flaps were good.Conclusion The flaps have less anatomic variation or sacrificing major vessels but have reliable blood supply and can restore good sensation after operation.They are ideal flaps for repairing heel soft tissue defects.

Objective To evaluate biochemical characteristics and the trend of diabetic complications in patients with newly-diagnosed type 2 diabetes from 1994 to 2008. Methods We utilized the database of the diabetes complications assessment and analyzed the metabolic disorder and the diabetic complications in the patients with newly diagnosed diabetes. Results 2 085 cases were collected, including 1189 males and 896 females. The average age of onset of diabetes was 51.6±13.1 and 54.6±7.9 yrs respectively in 2008 and 1994. During 1994,no case was found in subjects aged 20-29 yrs and 5% of the patients were aged 30-39; but 2% of patients aged 20-29 and 16% aged 30-39 yrs were found in 2008. BMI was increased from 24.48±4.15 in 1994 to 26.03±3.63 in 2008. Percentage of patients with abnormal BMI ( ≥25 kg/m2 ), WHR [≥0.90 (male) or ≥0.85 (female)]increased significantly from 63.6%, 75.0%, and 71.4% in 1994 to 79.6%, 95.2%, and 93.8% in 2008,respectively. Both SBP and DBP were not significantly changed. The fasting blood and postprandial blood glucose,HbA1c decreased from 10.3 mmol/L, 15.2 mmol/L, 11.1% in 1994 to 9.0 mmol/L, 14.3 mmol/L, and 8.6% in 2008, respectively. The average TG level increased from 1.7 mmol/L in 1994 to 2. 1 mmol/L in 2008,however, TC and HDL level were not significantly changed. The prevalence of diabetic retinopathy decreased from 28.2% in 1994 to 3.9% in 2008. The prevalence of diabetic nephropathy increased from 17.7% in 1994 to 24.6% in 2008. The prevalence of diabetic cardiovascular disease increased from 14.3% in 1994 to 24. 1% in 2008. Compared with the patients without microvascular complications, the patients with microvascular complications had higher SBP, DBP, and HbA1c( 136/78 vs 130/77 mm Hg, 9.41% vs 9.11% ). The patients with macrovascular complications had older age, higher SBP, TC, and TG than those without macrovascular complications (53.4 vs 50.0 yrs; 132 vs 129 mm Hg ; 5.3 vs 5.1 mmol/L and 2.6 vs 2.1 mmol/L). Conclusions In the studied newly-diagnosed diabetic patients from 1994 to 2008, there were increasing incidences of obesity and hypertriglyceridemia. However, the prevalence of diabetic retinopathy decreased significantly, while that of nephropathy showed no significant change.Cardiovascular complications were markedly increased.

Objective To identify the pathogen distribution and antibiotics resistance of blood stream infection(BSI) in the pediatric surgery intensive care unit(PSICU).Methods The clinical data of 138 pediatric patients diagnosed with BSI from January 2011 to December 2015 were collected in PSICU,and the distribution of pathogens and drug resistance were retrospectively analyzed.Results The incidence of BSI was 3.88‰(138/35.524)in the five years,the majority of the BSI cases occurred under one year old,and the mortality was 13.77%(19/138).A total of 179 strains were isolated from blood samples of 138 patients,of which gram-positive bacteria,gram-negative bacteria and fungi accounted for 60.89%(109/179),22.91%(41/179)and 16.20%(29/179)respectively.The most common gram-positive bacteria was coagulase-negative staphylococcus (84/179,46.93%).The predominant gram-negative bacteria were Acinetobacter baumannii(15/179,8.38%),Klebsiella pneumonia(12/179,6.70%) and Escherichia coli(6/179,3.35%).The rate of carbapenems-resistant Acinetobacter baumannii increased continuously in the study period.Non-albicans Candida was the most common fungi (14/179,7.82%).The resistance rate of multi-drug resistant strains to carbapenems significantly increased.Conclusion The incidence of BSI in PSICU increases,and the mortality in children younger than one year is high.Better understanding of distribution of BSI pathogen could provide more effective antibiotic prescription.