The regulation of mobile medical devices is one of the hot topics in the industry now. The definition, regulation scope and requirements, potential risks of mobile medical devices were analyzed and discussed based on mobile computing techniques and the FDA guidance of mobile medical applications. The regulation work of mobile medical devices in China needs to adopt the risk-based method.
China ; Equipment and Supplies ; standards ; Mobile Applications ; standards

Objective:To improve the efficient use of assets, prevent and eliminate the waste and loss.Methods: We improved the standards of medical scrapped evaluation and made full use of the residual value of scrapped equipment for the issues that the program and technical appraisal of medical scrapped evaluation were not standardized, the residual value was not accurate and the disposal was too careless, etc.Results: The residual value was useful for the standard and reasonable approval process of scrapped medical equipment.Conclusion: The perfect disposal process of medical equipment ensures that the fixed assets of hospital are complete and security. Making full use of residual value of the scrapped equipment can increase efficiency of the use of hospital assets and eliminate the waste of assets.

Objective To quantitatively analyze brucellar spondylitis, tuberculous spondylitis and spinal metastatic tumors by dynamic contrast-enhanced (DCE)-MRI, and to evaluate the quantitative DCE-MRI in the differential diagnosis of brucellar spondylitis, tuberculous spondylitis and spinal metastatic tumors. Methods This was a retrospective study including 30 patients with brucellar spondylitis, 30 with tuberculous spondylitis, and 30 with spinal metastatic tumors. The clinical and demographic data were collected. All patients received routine MRI and DCE-MRI examinations. Volume transfer constant(Ktrans), rate constant(Kep), extravascular extracellular volume fraction(Ve) and plasma volume fraction(Vp) of diseased vertebral bodies of the patients with brucellar spondylitis, tuberculous spondylitis and spinal metastatic tumors were measured on perfusion parameter maps. All indexes showed non-normal distribution. Differences of all indexes were compared and analyzed statistically with rank-sum test among the above diseases. Results For brucellosis spondylitis, spinal tuberculosis, and vertebrae metastasis, the values of Ktrans were(0.716 ± 0.017),(0.316 ± 0.004),(0.986 ± 0.012)min-1, the values of Kep were(1.326 ± 0.018), (0.747 ± 0.005),(2.899 ± 0.054)min-1, the values of Ve were 0.541 ± 0.011, 0.427 ± 0.017, 0.338 ± 0.007 and the values of Vp were 0.034 ± 0.003, 0.029 ± 0.003, 0.049 ± 0.007. The differences suggested statistical significance(H=50.24, 52.49, 48.31, 46.54, P<0.01) among the three diseases. Conclusion DCE-MRI quantitative analysis is helpful in the differential diagnosis of brucellar spondylitis, tuberculous spondylitis and spinal metastatic tumors.

Objective To explore the value of dynamic contrast-enhanced (DCE).MRI in the early diagnosis of brucellosis spondylitis.Methods Fifty-six patients (24 female and 32 male) with Brucellosis with average age of (49± 3)years were retrospectively analyzed.Inclusion criteria:The patients with clinically diagnosed brinell coli spondylitis,drops of serum agglutination test degree 1:100＞(++),Hu＞red plate agglutination test (+ +),enzyme-linked immunosorbent assay to detect specific antibody IgG/IgM (+).Exclusion criteria:Pregnant and lactating women,patients with MRI examination contraindications and spinal tuberculosis,myeloma or other spinal disease,patients with the cervical,thoracic and lumbar 5 vertebral body involvement.The patients were classified into early lesion group and lesion group.Early lesion group was defined as low back pain less than a month,enzyme-linked immunosorbent assay positive IgM and negative IgG results,and no abnormality in conventional MR imaging,while lesion group was defined as low back pain for longer than 3 months,enzyme-linked immunosorbent assay positive IgG and negative IgM and marked lesion in conventional MR imaging.All the patients conducted with conventional MRI and DCE-MRI scan.The differences of the Ktrans,Kep,Ve and Vp between the vertebral lesions,early lesions of vertebral body and normal tissues were measured and compared.Results The values of Ktrans,Kep,Ve and Vp were significantly different between the vertebral lesions [(0.856±0.539) ml/min,(1.482±0.711) ml/min,0.542±0.267,0.034±0.017] and normal tissues [(0.315±0.298) ml/min,(0.713±0.548) ml/min,0.358±0.259,0.056±0.03](all P＜0.05).The values of Ktrans,Kep and Vp were significantly different between the early lesions of vertebral body and normal tissues (all P＜0.05),while no difference was found for Ve between the two groups (P＞0.05).Conclusion DCE-MRI quantitative analysis plays a role in the early diagnosis of the brucella spondylitis.

Objective To compare wedge biopsy and disposable automatic biopsy gun biopsy for the diagnosis of pancreatic cancer. Methods The clinical data of 217 patients with unresectable pancreatic cancer undergoing palliative operation and biopsy were retrospectively analyzed in our hospital from March 25,2006 to March 25,2011.Group A(wedge biopsy) consisted of 120 cases and B( disposable automated biopsy gun biopsy) of 97 cases.The success rate of biopsy,the positive rate of biopsy,the accuracy of diagnosis and the incidence of postoperative complications were calculated. Results The success rate,positive rate,diagnostic accuracy and the incidence of postoperative hemorrhage of group A and B were 100％,97.5％,97.5％,1.7％ and 100％,99％,99％,1.0％,respectively ( all P ＞ 0.05 ).The incidence of postoperative pancreatic leakage in group A and B were 11.7％ and 2.1％ (P =0.007 ).Conclusions Intra-operative biopsy for the diagnosis of pancreatic cancer using disposable automated biopsy gun biopsy has significantly decreased the incidence of post-biopsy pancreatic leakage as compared with wedge biopsy.

Objective To investigate the value of multi-slice spiral CT image texture analysis in differentiating metastatic (MLN) from non-metastatic lymph nodes (NLN) in patients with rectal cancer.Methods Thirty five patiets with rectal cancer who were pathologically confirmed by total mesorectum excision were included retrospectively,with regional lymph nodes (short-axis diameter of larger than 3 mm)found in preoperative CT images.All the patients underwent preoperative abdominal and pelvic dynamic contrast-enhanced CT scan.Regional lymph nodes were identified according to pathological findings,and were divided into MLN and NLN groups.The short-axis diameter,short-to long-axis diameter ratio of lymph nodes were manually measured and calculated,and the texture features,including skewness,kurtosis,variance,entropy and inverse difference moment,were analyzed.The above parameters between MLN and NLN groups were compared using independent sample t test or Mann-Whitney U test.ROC curve analysis was performed regarding the statistically significant parameters and the areas under curve (AUC) were calculated.Multivariate Logistic regression analysis was accomplished to obtain the independent predictive factor of diagnosing regional lymph nodes.Results A total of 68 regional lymph nodes were obtained and consisted of 31 MLNs and 37 NLNs.The short-axis diameter,kurtosis,and entropy of the MLN group were significantly higher than those of the NLN group (all P＜0.05).Whereas,the short-to long-axis diameter ratio,skewness,variance,and inverse difference moment did not differ significantly between the two groups (all P＞0.05).The AUC for distinguishing MLN from NLN of the short-axis diameter,kurtosis and entropy were 0.79,0.67,and 0.85,respectively.Multivariate logistic regression analysis showed that only entropy (odds ratio=8.48,95％ confidence interval was 3.01 to 23.92,P＜0.01) was screened out as the independent variable,which suggested that the entropy was the unique predictor for characterizing regional lymph nodes of rectal cancer.Conclusion Multi-slice spiral CT images texture analysis can facilitate the accurate differentiation between MLN and NLN in patients with rectal cancer,and especially the entropy has the optimal reference significance.

Objective To investigate the feasibility and safety of day surgery holmium:YAG laser lithotripsy for urinary tract calculi.Methods A total of 294 cases of urinary tract calculi were treated with ureteroscopic holmium:YAG laser lithotripsy from October 2010 to September 2011.There were 147 cases for day surgery and 147 cases for inpatient surgery group.The time of waiting to be admitted,success rate,operative time,intraoperative and postoperative complications,hospitalization costs were analyzed in each group.Results The mean operative time of the day surgery group and the inpatient surgery group was 46.4± 16.5 and 52.1± 18.3 min.The difference in the mean operative time between the two groups was not statistically significant (P＞0.05).The stone free rate was not statistically significant between the day surgery group (95.9％) and the inpatient surgery group (92.5％,P＞0.05).The complication rate of the day surgery group was slightly lower than the inpatient surgery group (5.0％ VS 5.4％),but the differences between the two groups was not statistically significant (P＞0.05).The mean time of waiting to be admitted of the day surgery group was statistically shorter than the inpatient surgery group(2.5±1.3d VS 7.6±3.6 d,P＜0.05).Patients in the day surgery groups spent statistically less money than patients in the inpatient surgery group (5433.4 VS 8612.9,P＜0.05).Conclusions Day surgery for ureteroscopic holmium:YAG laser lithotripsy could be safe with lower costs and incidence of postoperative complications,faster postoperative recovery.Pre-operative adequately and selecting appropriate patients are helpful to reduce and control of intraoperative and postoperative complications.

Objective To explore the expression of P53 and mettl-9 gene in colon cancer tissues and inflammation tissues and normal adjacent tissues and study its relationship with colon cancer.Methods The morphologic situation of histiocyte after H.E.stained was observed.The real-time fluorescent quantitative PCR was applied to detect the gene expression of P53 and METFL-9.Results The expression of P53 gene in inflammation tissues was significantly higher than that in cancer tissues and adjacent tissues(P ＜0.05).The expression of P53 gene in cancer tissues was significantly lower than adjacent tissues and infiammation tissues.METTL-9 gene expression in inflammation tissues was significantly lower than cancer tissues and adjacent tissues(P ＜0.05).In cancer tissues,P53 gene and METFL-9 gene were negative related.Conclusions The mutations of P53 gene played an important role in the course of colon cancer,its downstream gene METTL-9 was highly expressed in colon cancer,and the 9-methyl-converting enzyme which produced by transcription and translation might lead gene hypermethylation in the colon cancer,and thereby promoted the development of colon cancer.

Objective:This study aims to examine the clinicopathological features, diagnosis, and treatment of pulmonary margin-al zone B-cell lymphoma of mucosa-associated lymphoid tissue (PMZL-MALT). Methods:The clinicopathological features and immu-nohistochemical staining of CD20, CD79a, CD5, CD10, CD23, CyclinD1, and Ki-67 in seven patients with PMZL-MALT were ana-lyzed. Results:These patients, with a median age of 58 years, included three males and four females. Most of the patients suffered from cough, anhelation, and irregular fever. No specific imaging manifestation was observed. Tumor cells were positive for CD19 and CD20 but negative for CD5, CD10, and CyclinD1. The positive rate of Ki-67 was low. Conclusion:PMZL-MALT cases are easily misdiag-nosed because of the absence of specific clinical characteristics and X-ray features. Final diagnosis depends on pathological examina-tions.

ObjectiveTo investigate the impact of age and sex on virologic responses rates to peginterferon alfα-2a and ribavirin treatment in patients with chronic hepatitis C.MethodsThe medical records of 449 chronic hepatitis C patients,treated with peginterferon and ribavirin in Department of Infectious Diseases,the Second Affiliated Hospital,Harbin Medical University,were retrospectively analyzed.These patients were divided into three groups according to age:patients ＜40 years (n =131 ),patients 40-50 years ( n =131 ) and patients ＞ 50 years ( n =187 ).The virologic response rates,the incidences of side events,and the rates of patients receiving ≥ 80％ of planned peginterferon alfα-2a or ribavirin dose were compared between male and female patients in the three groups.The influential factors on sustained virologic response (SVR) of patients were studied by multivariate analysis.Results For genotype 1,in patients ＜ 40 years group,the SVR rate of female was significantly higher than that of male (75.0％,30/40 vs 54.0％,27/50; P ＜0.05 ) ; in patients 40-50 years group,there was no significant difference in the SVR rate between male and female (51.0％,25/49 vs 53.7％,22/41 ; P ＞ 0.05 ) ; in patients ＞50 years group,the SVR rate of female was significantly lower than that of male (31.1％,19/61 vs 50.7％,34/67; P ＜0.05).For genotype 2,there were no significant differences in virologic response rates between male and female in the three groups.The incidence of adverse events of patients aged ＜ 40 years group,40-50 years group,＞ 50 years group,were 51.1％ (67/131),51.1％ (67/131),and 70.6％ (132/187),respectively,and the incidence of adverse events of patients aged ＞ 50 years was significantly higher than those of other groups ( P ＜ 0.001 ).For genotype 1,in patients ＞ 50 years group,the rate of patients receiving ≥80％ of planned ribavirin dose of female was significantly lower than that of male (42.6％,26/61 vs 62.7％,42/67; P ＜ 0.05).In multivariate analysis,the independent factors associated with SVR of patients aged ＞ 50 years were sex ( P =0.013 ),genotypes ( P =0.002 ),cirrhosis ( P =0.004 ),≥ 80％ of planned ribavirin dose ( P =0.008 ) and presence of rapid virologic response (RVR) ( P =0.001 ).ConclusionsFor genotype 1 patients,in patients ＜ 40 years group the SVR rate of female is higher than that of male; in patients 40-50 years group,male and female share similar SVR rates;in patients ＞ 50 years group the SVR rate of female is lower than that of male.Age and sex has no impact on virologic responses rates for genotype 2 patients.