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<p><b>OBJECTIVES</b>To increase the number and quality of adverse events reported in medical devices, dealing with adverse events that have occurred in time, preventing the occurrence of adverse events, and ensuring the safety of device use.</p><p><b>METHODS</b>Based on risk management methods, through a comprehensive analysis of risk of adverse events, scientifically assessing the risk level and completing the classification of adverse events. Administrative supervision departments take corresponding supervision measures according to the classification results.</p><p><b>RESULTS</b>Building a classification monitoring model of medical device adverse events based on risk management.</p><p><b>CONCLUSIONS</b>The classification of adverse events will help the administrative supervision department to focus on the work, reduce the workload, and improve the efficiency of supervision.</p>
Subject(s)
Equipment and Supplies , Classification , Risk ManagementABSTRACT
Objective To evaluate the clinical efficacy of facial acupoint catgut embedding therapy in the treatment of skin aging.Methods The sixty patients with facial skin aging were randomly divided into catgut embedding group and sham embedding group,30 cases each.Catgut embedding group received catgut embedding therapy; the control group also received acupuncture but not the filling line.Two groups were operated 2 times,once every 21 days,a total of 42 days.The facial skin aging were evaluated and analyzed using VISIA and CK complexion analysis system.Results In catgut embedding group,wrinkles,pores,texture,moisture and elasticity were improved signficantly (P＜0.05).Ultraviolet,pigmentation,telangiectasia and melasma were not obviously improved.There was no significant change in the sham embedding group.Conclusions Facial acupoint catgut embedding therapy is an effective method for the treatment of skin aging with no significant side effects.
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Objective: To observe the treatment of allergic rhinites by acupuncture combining with Ssemiconduct laser. Methods: Sixty patients were divided into 2 groups.The treatment group of 30 cases were treated by acupuncture and semi-conduct laser on points of Taibai, Taiyuan, Lieque, Fenglong, all in both sides. While the control group of 30 cases were treated by medicine. Results: The total effect rate was 86.7% in treatment group and 36.7% in the control group. There was a significant defference between the two groups (P
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Objective: To observe the effect of acupoint catgut embedding therapy in treating postpartum obesity. Methods: According to the clinical standard, observing the effect of reducing weight through 120 postpartum obesity patients by the therapy of acupoint catgut embedding. Results: The follow-up observation showed that the result was satisfied. The total effective rate was 91.67%. Conclusion: The acupoint catgut embedding therapy played a positive role in reducing weight of the postpartum obesity patients. This therapy can achieve reducing weight well by enhancing the physical body, regulating endocrine, restraining appetite, and accelerating fat metabolism.