广东省透析装置不良事件重点监测报告分析

Analysis of Reports on Dialysis Device Adverse Events Monitoring in Guangdong Province

目的通过重点监测分析透析装置不良事件。方法省内随机设立9个二级以上医院,详细记录每例透析患者所用设备、材料等信息,结合全省医疗器械不良事件网络报告平台数据,用Excel对相关信息进行统计分析。结果在40 120人次透析中,共收到透析装置导致的不良事件51例,不良事件主要表现为血压异常、胸闷、呕吐、凝血、空气栓塞;引起不良事件的原因主要有材质原因、设备故障、患者自身未按规定频次透析等。出现可疑不良事件后的处置措施均为中止透析,适当休息,无需特殊处理,未出现死亡病例。结论通过重点监测,广东省内未见透析装置严重不良事件。透析作为一种常规治疗手段,随着其使用的普及和使用量的增加,其引发的可疑不良事件也越来越多,由于医护人员对不良事件定义、表现、认识模糊,存在少报、漏报、或不报的现象,因此要加强不良事件监测相关政策法规的宣贯,提高基层医疗机构及企业人员对不良事件的鉴别能力和上报意识,采取相应的措施,提高透析装置使用的安全性,减少不良事件的重复发生。

Objective To analyze dialysis device adverse second-class hospitals randomly in Guangdong province, events via intensive monitoring. Methods To monitor 9 and to record the information of equipments and materials used by each dialysis patients in details with excel software and then to analyze the statistics. Results There are altogether 51 adverse events among 40 120. The main manifestations are dysarteriotony, suppression in the chest, vomiting, blood coagulation and air embolism. It is suspected that they are mainly caused by equipment materials and failures as well as irregular visits by the patients. Usually the measures taken to handle these performances are to terminate dialysis and ask the patients to have a good rest. Till now no death occured. Conclusion There has been no adverse events in Guangdong province till now. But as a regular treatment, with its increasing application and popularization of dialysis, suspected dialysis adverse events will increase, which will directly affect the life quality and even safety of patients. But because of medical workers＂ different views and vague understanding of adverse events, they may un- derreport or even fail to report these adverse events. Therefore, vocational training of monitoring workers at the grassroots level has to be strengthened, discriminating and analyzing ability of dialysis medical workers have to be improved and monitoring work has to be continued. So that administrative departments can take relevant executive measures to tackle potential events and offer scientific evidence for these measures. Ultimately adverse events can be timely and effectively controlled and prevented.