The importance of software version in the medical device software supervision does not cause enough attention at present. First of all, the effect of software version in the medical device software supervision is discussed, and then the necessity of software version in the medical device software supervision is analyzed based on the discussion of the misunderstanding of software version. Finally the concrete suggestions on software version naming rules, software version supervision for the software in medical devices, and software version supervision scheme are proposed.
Equipment and Supplies ; Software

Objective: The FDA regulation requirements for medical device software are relatively mature and systematic, and the research on the FDA regulation thinking of medical device software helps to promote the regulation work of the medical device software in our country. Methods:Based on the comparison of the 1998 edition and 2005 edition FDA software submission guidance, the trend of the FDA regulation requirements for medical device software was analyzed, and then its regulation thinking was discussed according to other current effective software-related guidance. Results:FDA integrally improves the submission requirements for all medical device software, especially for the minor Level of Concern software, and simplifies the requirements for design specification, verification and validation, but strengthens the requirements for traceability analysis and revision history. Conclusion: The regulation work of the medical device software in our country needs to fully consider the particularity of the medical device software, strengthen the audit of software quality management system, implement the software traceability analysis, and determine the regulation requirements for software change.

Estimation the postmortem interval(PMI)is an important subject in forensic medicine practice.Recent research has found that the DNA molecular would degrade immediately following death,and the quantity of DNA in nuclear would be decreasing along with the elapse of the time since death.Seven parameter of cell nuclear,including the area and integral optical density,were chosen and the changes of DNA content in the brain cells of 15 rats were determined at every one hour during 48 horus after death by the auto TV imange analyses system.The results showed that the degradation rate of DNA in nuclear has a certainty relationship with early PMI in rats and indicated that the determination of the quantity of DNA in nuclear is the major method to estimate the PMI.

Objective To explore the correlations between emotions and self-concept in patients with traumatic brain injury. Method The Chinese version of the Positive and Negative Affect Scale and the Tennessee Self-Concept Scale was used to test 178 patients with traumatic brain injury.Results The mean scores on positive and negative emotions were (1.93±0.53) and (2.76±0.61), respectively. The mean score on self-concept was (2.45±0.31). The positive emotions of patients were positively correlated with the level of self-concept and the negative emotions negatively with the level of self-concept (r=0.437and -0.363respectively,bothP<0.01). Conclusions For patients with traumatic brain injury,the negative emotions outnumber the positive emotions and their self-concept was at lower level. Nurses should take measures to improve their positive emotions and reduce their negative emotions in order to improve their self-concept level.

Integrating visualization toolkit and the capability of interaction, bidirectional communication and graphics rendering which provided by HTML5, we explored and experimented on the feasibility of remote medical image reconstruction and interaction in pure Web. We prompted server-centric method which did not need to download the big medical data to local connections and avoided considering network transmission pressure and the three-dimensional (3D) rendering capability of client hardware. The method integrated remote medical image reconstruction and interaction into Web seamlessly, which was applicable to lower-end computers and mobile devices. Finally, we tested this method in the Internet and achieved real-time effects. This Web-based 3D reconstruction and interaction method, which crosses over internet terminals and performance limited devices, may be useful for remote medical assistant.
Diagnostic Imaging ; Image Processing, Computer-Assisted ; Imaging, Three-Dimensional ; Internet ; Software

Churg-Strauss Syndrome ; complications ; Coronary Artery Disease ; complications ; Humans ; Male ; Middle Aged

BACKGROUND: Lower limb motion is complex.Proper human motion parameters detection is important for knee prosthesis control.Current lower limb prosthesis control information source is physical quantity related to motion information,which can directly reflect biomechanical characteristics of human motion.It is simple to collect and applicable for real-time control.The lower limb prosthesis utilizes one or several sensors to detect human motion information.OBJECTIVE: To develop a sensor system that can collect human motion information controlled by intelligent lower limb prosthesis.METHODS: Relationship between pivot axis installation potentiometer and knee joint flexion angle was acquired from analysis of four-bar linkage with a fixed pneumatic cylinder.In addition,the proper hall sensor installation position was selected to solve the two-solution problem.A sensor signal acquisition experiment was designed.The treadmill ensure that walking speed was completely under control.Knee joint flexion angle at toe-off in different walking speeds was measured.Curve fitting process provided the correspondence between them.RESULTS AND CONCLUSION: Knee joint flexion angle at toe-off increased with increasing walking speed.Quadratic curve fitting obtained a good effect.Results show that under horizontal walking state,potentiometers and Hall-sensors can be used to detect walking speed of lower limb prosthesis,and distinguish support phase and swing phase.

The infection of HBV may cause acute and chronic hepatitis B,and potentially lead to hepatocirrhosis and liver cancer.As a defense mechanism of organism to resist external infection,RNA interference(RNAi) has become a powerful tool for us to study its effects on antiviral infection and gene therapy in recent years.In this article we summarize the mechanisms of RNA interference and the progress on anti-HBV infection studies by RNAi.

Objective To study the identification of rare Nocardiaotitidiscaviarum and its drug sensitivity .Methods Morpho-logical ,physiological and biochemical phenotype identification methods combined with 16S rRNA sequence analysis were employed to identified the bacteria strains .Broth method was used to detect their drug sensitivity .Results The clinically isolated Nocardia strain was identified as Nocardiaotitidiscaviarum which was resistant to piperacillin ,erythromycin ,ceftazidime ,cefoperazone ,gen-tamicin ,cefoxitin ,piperacillin/tazobactam ,and was sensitive to vancomycin ,levofloxacin ,imipenem ,etimicin ,ciprofloxacin ,amika-cin ,sulfamethoxazole .Conclusion 16S rRNA gene sequence analysis can be used to identify Nocardia otitidiscaviarum ,and sulfa drugs shows good therapeutic effect .

Objective To evaluatate the impact of different anastomotic location and preventive ileostomy on postoperative anastomotic fistula in rectal cancer patients.Methods The clinical data of 316 cases of rectal cancer patients after total mesorectal excision from January 2015 to January 2016 were analyzed retrospectively.Patients were divided into anterior resection (AR) group,low anterior resection (LAR) group,uhra-low anterior resection (ULAR) group according to the anastomotic location.There were 33 cases of anastomotic fistula with preventive ileostomy or without and anastomotic leakage varied from mild to severe as grade A,B,C.Results There was no statistically significant difference in the incidence of anastomotic fistula between the different anastomotic location (x2 =3.829,P =0.147).In anterior resection group and low anterior resection group,there was no statistically significant difference in the incidence of anastomotic fistula whether or not a preventive ileostomy was performed (x2 =0.606,1.096,P =0.436,0.326).While in uhralow anterior resection group,preventive ileostomy helped dicrease the incidence of anastomotic fistula (x2 =11.667,P =0.001),and once happened the severity of the anastomotic fistula tended to be less severe.Conclusion The incidence of anastomotic fistula does not vary with anastomotic level in our study.Preventive ileostomy reduces the incidence of anastomotic fistula in patients with ultralow anterior resection.