高风险医疗设备质量控制检测结果与分析

摘要

目的:探讨医院在用高风险医疗设备使用过程中存在的问题及解决方法,以保障医院高风险医疗设备运行的安全性与有效性.方法:依据北京市医管局药事处急救、生命支持及高风险类设备质量控制指导意见(试行),对医院在用高频电刀、呼吸机和除颤仪高风险医疗设备实施检测,分析总结检测数据,并提出质量控制方案.结果:对56台除颤仪进行检测,不合格率为62.5％,其中除颤仪时间准确性问题在整个故障问题中的占比最大,约为73％;附件破损为15％、附件缺失为13％、其他故障为2％.对56台呼吸机进行检测,不合格率为41.07％,其不合格原因主要有耗材附件(占75.20％)、设备外观(占9.7％)及设备故障(占15.1％).对49台高频电刀的性能及电气安全进行检测,不合格率为10.2％,其不合格原因主要为参数故障(占33.30％)、附件故障(占61.60％)及设备外观问题(占5.10％).通过分析设备质量控制不合格的原因,制定相应的针对性措施,提高了临床使用质量.结论:从工程技术上对医院在用高风险医疗设备实施质量控制,能够保障医疗设备运行的的质量和安全.%Objective:To investigate the existing problems and solutions in the use procedure of medical devices with high-risk of hospital so as to ensure the safety and effectiveness of the operation of them in hospitals.Methods: Based on guidelines of the quality control of the Beijing municipal administration of hospital (On trail) for first aid, life support and high risk equipment, the detections of some high risk medical equipments, such as high frequency electric knife, ventilator and defibrillator, were carried out. And the relevant detected data were analyzed and summarized so as to put forward a plan of quality control.Results: A total of 56 defibrillators were detected, and the unqualified rate was 62.5％. Among them, the time accuracy of defibrillator was the main problem, and the proportion of time accuracy in whole fault problem points was about 73％. And the breakage rate of attachment was 15％, missing rate of annex was 13％ and the rate of other faults was 2％. For 56 ventilators, the unqualified rate was 41.07％. The main reasons of unqualified rate included annex of consumable (75.20％), appearance of equipment (9.7％) and equipment failure (15.1％). About the performance and electrical safety of 49 high frequency electric knives, the unqualified rate was 10.2％, and the main reasons of unqualified rate included parametric fault (33.30％), fault of annex (61.60％) and appearance of equipment (5.10％). Through analyzed the reason of disqualification and formulated the corresponding pertinence measurement, their qualities were enhanced in clinical practice.Conclusion:The quality control of high-risk medical equipment can ensure the quality and safety of these equipments. Therefore, it is benefit to ensure the safety and effectiveness of medical equipment of first-aid and life-support in long-time running from engineering technique.