The article has summarized the situation related to medical device naming, analyzed the problems of medical device naming in our country, put forward some new thinking in building the naming system of medical device in our country provided some reference on technical study of medical device naming.
China ; Durable Medical Equipment ; classification ; Terminology as Topic

The article has reviewed the administration technical structure and global application of the global medical device nomenclature(GMDN), analyzed the coordination between GMDN and the industry status of medical device in our country, put forward some suggestions on the applicaition of GMDN, provided some reference on raising the management level of medical device in our country.
Equipment and Supplies ; standards ; Terminology as Topic

Objective To investigate the effects of insulin resistance (IR)on hypoxia/reoxygenation (H/R)inj ury in PC1 2 cells and the protective effects of N-actyl-L-cystine (NAC)against H/R inj ury. Methods PC12 cells were treated with 100 nmol/L insulin to induce IR. The H/R injury model was established by Na2 S2 O4. CCK-8 assay was used to detect the cell viability. Glucose consumption was detected by glucose oxidase method. Activity of superoxide dismutase (SOD)was detected by xanthine oxidase method. The levels of malonaldehyde (MDA)were measured by thiobarbituric acid method. Flow cytometry was used to determine the apoptosis and mitochondrial membrane potential (MMP). Results High-insulin inhibited insulin-induced glucose uptake in PC12 cells without affecting the cell viability (P<0. 05). PC12 cells with IR exhibited lower SOD activity and higher levels of MDA (P<0. 05 ),and enhanced apoptosis and depolarization of MMP induced by H/R(P<0. 05). NAC neutralized these effects induced by IR(P<0. 05). Conclusion IR aggravates H/R injury in PC12 cells by enhancing oxidative stress and NAC reduces the H/R injury in PC12 cells with IR via inhibiting oxidative stress and stabilizing MMP.

Objective:To investigate the status of brain evoked potentials (BEP) and the relationship between BEP and psychiatric symptoms before and after treatment in patients with post-traumatic stress disorder (PTSD). Methods: P_(300), auditory evoked potential (AEP), visual evoked potential (VEP) of BEP, Symptom Checklist-90 (SCL-90) and Impact of Event Scale (IES) were used to evaluate 86 patients with PTSD (PTSD group) and 56 normal controls (control group), PTSD patients were followed up with the same markers after 3.5 months treatment.Results:Compared with the control group, PTSD patients showed delayed latency and increased amplitude of P_(300)-P_3, delayed AEP-N_2 latency, and delayed VEP-P_2 latency. Shortened latency and decreased amplitude of P_(300)-P_3, and shorted VEP-P_2 latency were found after treatment. The mostly items of BEP were significantly related to psychical symptoms before treatment, and the changes of BEP were significantly related to the alleviation of psychical symptoms after treatment.Conclusion:BEP might be state markers of PTSD. The clinical application of BEP in PTSD is emphasized.

Brain Computer Interface(BCI) is a direct information communication and control channel established between human and computer or other electronics devices and it is a wholly new communication system that does not depend on the brain's normal output pathways of peripheral nerves and muscles.The general constitutions and principles of BCI systems are introduced.In addition,research methods based on electroencephalograph are discussed and the existing problems and future trends of BCI are pointed out.

USA is the first country implementing the UDI program at national level,and the UDI rules and GUDID guidance have been issued by FDA recently to officially launch the implementation of UDI. The paper reviewed the advancement of UDI program,dis-cussed the framework of UDI system,analyzed the approaches of UDI implementation such as accredited issuing agencies and GUDID et al, and made some suggestions on the development of medical device coding system in our country.

This paper introduces the current status of Chinese medical device testing and inspection institutes. There are 53 such institutions, including 10 national institutions. Medical device testing and inspection institutions service in government regulation and supervision of medical devices, playing a technique support role for medical devices from registration before appear on market to monitor and supervision after listing. Meanwhile, they are important practitioners of medical devices standardization work. Finally, put forward the current problems and countermeasures of the inspection institutes in order to facilitate the sustainable development of our national medical equipment.
China ; Equipment and Supplies ; standards ; Health Systems Agencies ; Reference Standards

Objective To investigate the effect of continuous thoracic paravertebral block anal-gesia guided by sonography on pulmonary function after thoracotomy.Methods Sixty patients,male 29 cases,female 31 cases,aged 18-60 years,BMI 1 6-28 kg/m2 ,ASA grade Ⅰ or Ⅱ,who had under-went thoracotomy were divided randomly into 2 groups,30 cases each:group G with general anesthe-sia and postoperative patient controlled intravenous analgesia (PCIA),whereas group GP with general anesthesia combined with continuous thoracic paravertebral block (CTPVB)and postoperative continuous CTPVB.CTPVB were performed before induction as the patient was conscious so that the effect of CTPVB could be tested by blocking range.Both resting and coughing visual analogue scales (VAS)were recorded at the points of 30 minutes after extubation (T1 ),2 hours after operation (T2 ),6 hours after operation (T3 ),24 hours after operation (T4 )and 48 hours after operation (T5 ). Forced vital capacity (FVC),forced expiratory volume in the first second (FEV1 )and maximal mid expiratory flow (MMF)were measured by spirometer and the three maximal values were recorded at time points of entry of operating room (T0 ),T4 and T5 .Blood gas analysis was employed at corre-sponding time points by a blood gas analyzer and oxygen inhalation was ceased 30 minutes before drawing blood from radial artery.PaCO 2 ,PaO 2 and alveolararterial oxygen difference (PA-a O 2 )were recorded.Adverse effects were observed.Results Compared with group G,VAS when resting and coughing in group GP at T1-T5 decreased significantly (P <0.05).Compared with T0 ,FVC,FEV1 , MMF and PaO 2 at T4 ,T5 in both groups decreased significantly (P <0.05),PA-a O 2 increased signifi-cantly (P <0.05 ).Compared with group G,PaO 2 in group GP at T4 ,T5 increased and PA-a O 2 in group GP at T4 ,T5 decreased significantly (P <0.05).Conclusion CTPVB guided by sonography had excellent effect.It can not only improve pulmonary function after thoracotomy significantly but also promote intrapulmonary oxygenation.

Objective To investigate the role of NF-κB pathway in the development of intrathecal(IT)platelet-activating factor (PAF)-induced hyperalgesia in rats. Methods Sixty-four male SD rats (200-250 g) in which intrathecal catheters were successfully implanted without complications were randomly divided into 6 groups:group Ⅰ received artificial cerebro-spinal fluid (ACSF) 10 μl IT (n = 16); group Ⅱ received PAF 10 μg in ACSF 10 μl IT; group Ⅲ received 0.1% DMSO 2 ml intraperitoneally (IP) (n = 8); group Ⅳ, Ⅴ, Ⅵ received IP SC-514 (a selective IKK-β inhibitor) 10, 50, 100 mg/kg in 0.1% DMSO 2 ml respectively at 2 h before IT PAF. Paw withdrawal threshold to mechanical stimulation (PWMT) and paw withdrawal latency to thermal stimuli (PWTL) were measured before (baseline) and at 5, 15, 30, 45, 60 min and then every 30 min for another 4 h after IT administration. The animals were killed after the last pain threshold measurement at 5 h after IT PAF. The lumbar segment (L4-6) of the spinal cord was removed for determination of TNF-α and IL-lβ content (by ELISA).Results lntrathecal PAF induced tactile allodynia and thermal hyperalgesia rapidly, increased the expression of TNF-α and IL-lβ in lumbar spinal cord. Pretreatment with SC-514 attenuated PAF-induced hyperalgesia and inhibited the increase in TNF-α and IL-1β expression in the spinal cord. Conclusion NF-κB is involved in intrathecal PAF-induced hyperalgesia.

This paper analyses overall situation of the national quality inspection for medical devices in recent 13 years. The statistics cover the inspected varieties, sampling quantity and quality status. The achievements and suggestions are provided, which are helpful for future work.
Equipment and Supplies ; standards ; Humans