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Objective To analyze the problems found during the sampling inspection of the infusion and syringe pumps. Methods The present situation of the supervision of medical devices was explored,and statistical analysis was executed on the sampling inspection results of medical devices in 2016 to evaluate completely their quality and application.Results The medical devices had problems in uneven quality,low rate of coverage of sampling inspection,unreferencing YY 0709—2009 Medical Electrical Equipment-Part 1-8:General Requirements for Safety-Collateral Stanalard:General Requirements,Tests and Guidance for Alarm Systems in Medical Eleatriail Equipment and Medical Electrical Systems when registering product standard and technical requirements,external labeling,instruction manual and packaging.The qualification rate for sampling inspection was kept at low level in the past few years.Conclusion The supervision strategy is put forward for medical devices to enhance their overall quality.
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The Micro-infusion syringe pump has been widely used in infusion of various vasoactive agents. There are several modes of syringe replacement with advantages or limitations respectively. It is important to maintain the stability of hemodynamic parameters during the syringe replacement. In the times of the reformation of medical and medical insurance payment, it is worth paying attention to monitor costs of medical consumables. The large sample multicenter study is needed to reveal the relationships between the hemodynamic parameters and the sorts and volume of various vasoactive agents. It will provide the basis for the clinical choice of syringe replacement modes.
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Objective:is toTo detect a new type of micro-injection pump, its flow rate of quality control testing and syringe pump through the comparative analysis, and study its accuracy and stability. Methods:A certain brand of injection flow rate accuracy and stability of drug pumps and syringe pumps were detected by the use of professional Fluke infusion device analyzer and a dedicated infusion line. Results:Compared the injection pump with syringe pump flow rate of errors, a flow rate was 1 ml/h, t. The errordeviation range of micro-injection pump flow rate is larger than the syringe pump, and a flow rate was 25 ml/h and 50 ml/h, both the same, . Wwith drug detection time went on, a flow rate of injection pump has tended to stabilize. After the flow rate is stable, the longer the detection time is, the overall error is smaller. At the time of 15 min, test data are in line with national testing standards. Conclusion:The combination of injection pump and infusion pump, the micro-injection pump can meet the growing demand for clinical departments, and its stability and accuracy can meet the national standards.
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To explore the influences of the sterile injectors with different sources while the same capacity on the infusion precision of the syringe pump. With six injects with two brands were selected as the subjects and an electronic pump for measuring, flow test was carried out with the brands marked on the pump or not. There was significant difference between the flows from the syringe pumps marked with the injector brands and those without the mark of the brands. The sterile injector has to be set before using the syringe pump.
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Objective To monitor flow rate accuracy of the infusion pump and injection pump by using evidence-based methods , and to provide the basis for management and monitoring of medical clinical devices .Methods The flow rate accuracy of 188 infusion pumps and 253 injection pumps in the hospital were monitored ,the correction between instrument using length ,maintenance fre-quency and the flow rate accuracy were analyzed .And compared the impact of flow rate accuracy affected by instruments using length and maintenance frequency .Results The flow rate accuracy of infusion pumps and injection pumps in the hospital were 47 .34% and 79 .84% ,the instrument using length had no effect on flow rate accuracy (P> 0 .05) ,and the pass yield of maintain regular was higher the irregular maintaining ,the longer of maintenance cycle the lower of pass yield (P<0 .05) .Conclusion Using evidence-based methods in medical devices safety monitoring can help deep discover potential safety hazards ,identify problems and provide scientific solutions .
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Objective To find the safe vertical displacement for minimal infusion rate change of syringe pumps as the theoretical guidance for moving pumps. Methods The infusion volume within 1 minute after none and vertically moving 15, 25, 35, 50 cm of the pumps (microinfusion pump WZ-50C、WZ-50C2、BRAUN perfusor compact) at 10 ml/min were weighted and compared by the electronic balance. Results Significant differences of the infusion rate were detected. The difference of average infusion volume within 1 minute after vertically moving 15, 25, 35, 50 cm and non-movement were 0.004 (minimal),0.017, 0.033, 0.046ml. The lowest infusion curve of 15cm displacement stretches slightly above the horizontal plane until the inflexion in the section graph, leading to steeper in accordance with the increasing vertical displacement of the pumps,which implied the following drastic increase in infusion rate. Conclusions The minimal infusion change is obtained at 15cm, thus becomes the safe displacement height and the inflexion point of further soaring changes.
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Objective To study a simple surgical method for continuous rapid tissue expansion and its clinical application. Methods The operation was accomplished in two-stage procedures. First, expanders were placed in the subcutaneous pocket through interlesional perpendicular short incisions. Continuous expansion by trace syringe pump began from the second day after expander placement. The speed of water injection was set according to patient's algesthesia reaction and vascularity of skin. The second operation was carried out at the third to fifth day after the expansion completed.Results The method was put into clinical practice in 22 cases (16 cases of scar, 2 cases of capillary angioma, and 4 cases of black nevus), and 35 expanders were placed. The speed of water injection was set in 0.2～0.8ml/hr/100ml.The mean time of water injection was 15.3 days. In the process of expansion, all cases were satisfactory except 1 case, in which the expander exposed in the incision. After the second operation, all flaps survived except one showing distal skin necrosis. The result was satisfactory after 3 months to 1 year follow-up. Conclusion The procedure consists of expander placement through interlesional perpendicular short incisions and continuous expansion in advance, which maximally shortens the time of expansion and hospitalization. This expansion method is a simple, safe, reliable, and ideal rapid tissue expansion technique.