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

By analysis on existing problems of the classification, the suggestions were put forward to provide a reference for improving the classification of medical devices.
Equipment and Supplies ; classification

Through the analysis of the present problems of the quality of medical device standards in China, combined with the development trend of the last ten years of medical devices, the paper made proposals on the medical device standards quality evaluation system, so as to improve the medical device standards management level and the quality of medical device standard in our country.
China ; Equipment and Supplies ; standards

In order to make the pharmacy work of the county, township and community hospitals in our city gradually be undertaken by specially trained pharmacists, our hospital has carried out standardized and systematic training for pharmacists in primary hospitals and pharmacists who have just entered their posts, so that the trainees can basically master standardized prescription examination, dispensing, drug administration and pharmaceutical care as well as other related skills. At the same time, according to the actual training in our hospital, the status quo and existing problems of standardized training of pharmacists in our hospital have been summarized, and some suggestions for future pharmacist training have been put forward.

Objective To explore the state of cardiac autonomic nerve function in schizophrenia patients with metabolic syndrome and analyze its influence factors and to reduce the occurrence of sudden cardiac death of the patients. Methods A total of 168 cases of patients according with the ICD-10 schizophrenia diagnostic criteria were divided into group A(78 cases of schizophrenia with metabolic syndrome),group B(90 cases of schizophre-nia without metabolic syndrome)and another 92 normal cases were included as control group(group C). Twenty-four hours dynamic electrocardiogram was conducted respectively and the heart rate variability (HRV) was ana-lyzed. Results Values of LF,HF,SDNN,SDANN,RMSSD and PNN50 in group A and group B were much low-er than those in group C and they were statistically significant(P < 0.05). Values of LF,HF,SDNN,SDANN, RMSSD and PNN50 in group B were much higher than those in group A and they were statistically significant(P<0.05). Excluding the influence of schizophrenia ,logistic regression analysis showed that the influence factors of HRV values were course of the disease(OR = 1.864,95%CI 1.110~3.128),age(OR = 1.170,95%CI 1.018~2.491),types of antipsychotic drugs(OR=2.419,95%CI 0.976~1.835),abdominal obesity(OR=2.425,95%CI 1.347~4.366),blood pressure value(OR=1.263,95%CI 1.575~3.937),blood glucose value(OR=3.376, 95%CI 1.359~2.923)and blood lipid value(OR = 2.178,95%CI 1.492~6.756). Conclusions Schizophrenia patients with metabolic syndrome have obvious cardiac autonomic nerve dysfunction. Excluding the influence of schizophrenia itself,the other possible risk factors include course of the disease,age,types of antipsychotic drugs,abdominal obesity,blood pressure value,blood glucose value and blood lipid value.

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. Final y, put forward the current problems and countermeasures of the inspection institutes in order to facilitate the sustainable development of our national medical equipment.

Objective The present study was designed to analysis some misunderstanding on "medical devices classification rules" of CFDA, in order to correct understand and use the regulation. Methods The contents of "medical devices classification rules" by CFDA have been analysis and generalized. Results Through analyzing, we can conclude as followed: the priority principle of classification catalogue; the comprehensive judgment principle based on the classification decision table and special classification principles; medical devices' management class could be changed by CFDA according to risk analysis results. Conclusion It is helpful to reach an agreement on the classification of a medical device among the regulatory authorities, production enterprises and other aspects, and establish a solid foundation for CFDA's regulatory science.

Based on analyzing the classification catalog of medical device for rehabilitation, combined with the example,this paper discusses the principle of judgment of the classification of medical device for rehabilitation, and the naming and technical standards related to classification, puts forward the suggestions of classification management,attributes definition, and the naming, in order to provide support for promoting the reform of medical device classification management, and improving the level of scientific supervision.

By analysis on existing problems of the classification, the suggestions were put forward to provide a reference for improving the classification of medical devices.

Objective To investigate the impact of overweight on the prognosis of patients with acute mild ischemic stroke or moderate-high risk transient ischemic attack(TIA).Methods A total of 366 patients with acute mild ischemic stroke or moderate-high risk TIA who carried CYP2C19 loss-of-function alleles were included in the study.Baseline data were collected at admission,and clinical outcomes were collected within 3 months post-onset(primary outcomes:stroke recurrences within 3 months post-onset;secondary outcomes:composite outcome of stroke recurrence or death within 3 months post-onset,vascular events,and quality of life within 3 months).Kaplan-Meier method was used to plot the cumulative incidence curve of outcomes.Multivariate Cox proportional hazards mod-el and multivariate Logistic regression model were used to evaluate the relationship between over-weight and clinical outcomes within 3 months post-onset in patientswith ischemic stroke or TIA.The integrated discrimination improvement index(IDI)and net reclassification improvement index(NRI)were calculated to assess the predictive value of adding body mass index(BMI,whether o-verweight or not)based on traditional models for predicting the prognosis of acute ischemic stroke or TIA.Results After 3 months of follow-up,28 patients had stroke recurrence,1 patient died,and 31 patients had vascular events.The Kaplan-Meier cumulative incidence curve showed that the cu-mulative incidences of stroke recurrence,stroke recurrence or death,and vascular events after 3 months of onset were lower in overweight patients compared with non-overweight patients(Log-rank P＜0.05).Multivariate analysis showed that compared with non-overweight patients,overweight pa-tients had significantly reduced risks of stroke recurrence within 3 months(HR=0.24;95％CI,0.08 to 0.71),composite outcome of stroke recurrence or death(HR=0.24;95％CI,0.08 to 0.69),and vascular events(HR=0.22;95％CI,0.07 to 0.63),and significantly improved qual-ity of life within 3 months(OR=0.39;95％CI,0.20 to 0.76).The IDI and NRI calculations showed that compared with traditional models,the new model adding BMI(whether overweight)had significantly improved predictive ability for the prognosis of acute ischemic stroke or TIA.Conclu-sion Overweight may be a protective factor for the prognosis of TIA patients with acute mild ische-mic stroke or moderate-high risk who carry CYP2C19 loss-of-function alleles.Compared with non-o-verweight patients,overweight patients have reduced risks of stroke recurrence,composite outcome of stroke recurrence or death,and vascular events within 3 months post-onset,and improved quality of life within 3 months post-onset.