European Union (EU) medical device supervision system is more complete, has a lot of experiences and characteristics worth learning. This paper introduces a brief overview of the process of medical devices market in the EU, including three core medical device directives, process of obtaining CE mark, medical devices vigilance system and supervision after obtaining the CE mark, etc. Simultaneously, preliminary enlightenments of the EU medical devices supervision to our national medical devices' technical review process are discussed with the aim of providing reference for supervision, technical review unit and manufacturer.
Device Approval ; European Union ; Product Surveillance, Postmarketing

Objective To evaluate the clinical significance of phural effusion and/or ascites and their prognostic role in patients with acute pancreatitis.Methods The clinical data of 312 patients with acute pancreatitis were collected and analyzed retrospectively.Results Pieural effusion was found in 47 patients and ascites in 18.of 47 cases with pleural effusion,there were 31 cases(65.9%)of severe pancreatitis(P＜0.01)and 27 cases (57.4%)complicated by pseudocyst(P＜0.01).Among 18 cases with ascites,there were 14 cases(77.7%)of severe pancreatitis(P＜0.01).6 cases with pleural effusion and/or ascites died of multiple organs failure.Conclusion Pleural effusion and/or aseites is closely associated with severe pancreatitis.

Objective To evaluate the safety of conscious venous anesthesia with fentanyl and propofol in elderly patients over 70 during gastrointestinal endoscopy. Methods Clinical data of 826 elderly patients over 70, who underwent gastrointestinal endoscopy with venous anesthesia, were retrospectively analyzed. The patients were divided into 2 groups according to their ages, with 618 patients aging from 70 to 80 in group A, in which 342 received endoscopy and 276 underwent colonoscopy, and 208 patients older than 80 in group B, in which 112 underwent endoscopy and 96 had colonoscopy. Another cohort of 600 patients younger than 70, who underwent venous anesthetic endoscopy during the same time period, was randomly selected as the control group, in which 400 patients received endoscopy and 200 had colonoscopy. Blood pressure, heart rate, peripheral oxygen saturation (SpO2) and adverse reaction were monitored in each patient during the procedure and compared among different groups. Results No procedure-related perforation or sedation-related mortality was observed, and no procedure was terminated clue to sedation complication. The average dosages of propofol used in procedure of endoscopy in groups A, B and control were 54.22±21.36 mg, 40.22±12.46 mg, and 86.44±34.26 mg, respectively. The average dosages of propofol in colonoscopy were 82.56±40.64 mg, 45.36±15.44 mg and 102.23±46.32 mg, respectively. With same procedure, there was no significant difference in heart rate and blood pressure among different groups, nor was there any difference in these variables before and after the procedure in each group (P>0.05). Sedation exerted more influence on SpO<,2> in elderly patients. A total of 18 cases in groups A and B experienced SpO<,2> <90%, which was mainly due to aspiration of saliva and relieved by oxygen inhalation. Conclusion Under appropriate monitor, it is safe and feasible to give conscious sedation to elderly patients over 70 during gastroimestinal endoscopy.

Objective To investigate the dynamic abnormality of colon and anorectum in elderly patients with chronic functional constipation(CFC). Methods Forty-two elderly patients with CFC and twenty elderly healthy controls were selected. Total and segmental colonic transit time(CTT) were assessed radiographically by using oral radiopaque markers. Eight-lead water perfusion pressure measurement system and balloon were used to test the pressure and the perception threshold values of anus and rectum. Results (1) Total colonic transit time (TCTT) and sigmoid-rectum transit time (SRTT) were (49.0±16.4) h and (20.1±13.5) h in elderly patients with CFC, which were significantly prolonged compared with the controls [(25.2±7.7) h and (7.8±4.1) h, t=6.16 and 3.97,both P<0.05]. (2) The pressure of anal canal during defecation was (39.6±15.7) mmHg in elderly patients with CFC and (17.6±9.3) mm Hg in controls (t=5.79, P

Objective To evaluate the safety of intrvenous balanced propofol sedation with fentanyl in elderly patients during combined gastroscopy and colonoscopy procedures.Methods Totally 877 elderly patients aged (76.4 ± 8.5) years received intravenous propofol and fentanyl sedation during gastroscopy or/and colonoscopy procedures were assigned to groups:294 cases with only gastroscopy,257 cases with only colonoscopy and 326 cases with combined gastroscopy and colonoscopy.50 g Fentanyl and 0.5-1.0 mg/kg propofol were intravenously administered in the patients.The peripheral oxygen saturation,arterial pressure and heart rate were monitored and recorded during procedures.Results There were no procedure-related perforations and sedationassociated severe complications and mortalities,and no one need stop endoscopy procedures in all the patients.The average dosage of propofol in combined,gastroscopy and colonoscopy groups were (100.4±38.5) mg,(130.4±50.5)mg and (170.3± 60.3)mg,respectively.There were no significant differences in heart rate,arterial pressure and rate of cardiovascular events among groups (P＞0.05).The rate of respiration events in the above groups were 9 cases(3.1％),6 cases(2.3％)and 13 cases(4.0％),respectively (P＞0.05).Decrease of peripheral oxygen saturation was mainly induced by the aspiration of oral secretions and snoring.Conclusions Intravenous balanced propofol sedation provides safe and effective sedation in the elderly undergoing combined gastroscopy and colonoscopy.

Numerous epidemiologic studies have shown that there is a strong inverse relationship between high-density lipoprotein cholesterol levels and artherosclerosis. The first atheroprotective mechanism of HDL is the RCT(reverse cholesterol transport). Recently,considerable pharmacological trials have focused on targeting critical proteins and enzymes in RCT including apoAⅠ, ATP binding cassette transporter A1 and cholesteryl ester transport protein etc. A number of new drugs have demonstrated conspicuous protective effects on artherosclerosis. Therefore RCT will become an attractive target for prevention and cure of dyslipidamia and artherosclerosis.

Objective To overcome the disadvantages of the traditional auscultating method and design the electro-auscultating visual system integrating the monitoring and recording functions.Methods The portable system consisted of the module pre-gathering and electro-auscultating heart-sound signal,the circuit of A/D converting and MCU,as well as the device of signal LCD-displaying in real-time and the USB mass storage device.Results Portable electro-auscultating system was realized,which integrated the functions of watching,monitoring and recording.Conclusion The portable system is more convenient for clinical doctors to get correct information from patients,benefiting to the clinical pathology-statistics and profound development of the related data.

Colorectal cancer is one of the common malignancies of the digestive tract, and endoscopic submucosal dissection (ESD) has been widely used in the treatment of early colorectal neoplasms. The risk factors of non-curative resection in ESD for early colorectal neoplasms have been confirmed in many studies. This article reviewed the advances in study on risk factors of non-curative resection in ESD for early colorectal neoplasms.

Objective To explore the clinical efficacy in bilateral lumbar foraminal stenosis (LFS) after treatment with bilateral facetectomy combined with pedicle screw fixation and interbody fusion.Methods A total of 41 cases of patients with bilateral LFS underwent bilateral facetectomy combined with pedicle screw fixation and interbody fusion from February 2010 to August 2013 in Department of Spine Surgery,the People's Hospital of Tianjin City,were retrospectively analysed.The clinical efficacy was assessed by Oswestry disability index (ODD questionnaire and visual analogue scale (VAS) before and after operation,anterior and posterior disc height and L1-S1 angle were measured as well.Then the ODI and VAS scores,and changes in anterior and posterior disc height and L1-S1 angle were calculated at the time of the last patient follow-up visit.Results All 41 patients were followed up for 12 to 36 months,with an average of (26.2±2.4) months.Compared with preoperation,at the time of the last follow-up visit the back pain VAS score,leg pain VAS score and ODI were decreased,while the anterior and posterior disc height were increased,there were statistically significant differences (P＜0.05).No statistically significant difference was found in L1-S1 angle between preoperation and postoperation (P＞0.05).Conclusion The short-term clinical curative effect of posterior bilateral facetectomy combined with pedicle screw fixation and interbody fusion in the treatment of bilateral LFS is satisfactory.

A novel antimicrobial peptide, named as perinerin (GenBank accession No. P84117), was isolated and characterized from Asian marine clamworms, Perinereis aibuhitensis Grube. Perinerin showes powerful and broad activity against both grampositive and gramnegtive bacteria in vitro, especially on Pseudemonas aeruginosa. To obtain large amounts of active perinerin and characterize its main physiochemical features, The perinerin weve expressed in Pichia pastoris. Intact perinerin gene amplified by the modified gene SOEing method(Gene splicing by overlap extension)was cloned into expression vector pPICZ?A and obtained recombinant vector pPICZ?APEN, then pPICZ?APEN was expressed in the Pichia pastoris GS115. The expressed sample was analyzed by TricineSDSPAGE. The results showed that Pichia pastoris was a suitable system producing the secreted form of perinerin. Bioactivity assay showed that the recombinant perinerin had marked antimicrobial effects.