摘要
目的本研究开展了胎儿监护仪风险管理及质量控制方面的实践研究,通过质控专项检查工作,了解全院胎儿监护仪使用过程当中存在的问题并提出相应的解决方法,从而降低临床应用风险。方法建立完善的风险等级划分评估体系,制定并实施质量控制检查计划,以实施检查得到的数据为依据,进行评估分析。结果 142台被检查的胎儿监护仪中,有15台胎儿心率误差超过了5%,有26台系统时间出现了偏差,有17台系统语言由默认的英语变更为其他国家语言,有8台非法关机,有6台遗失了SOP操作规程,其它检测项目合格率均为100%。结论通过开展质量控制检查,发现胎儿监护仪在使用过程当中存在的不安全因素,提出了多种相应的整改措施及解决方案,以减少此类设备在今后的使用过程中出现类似的安全隐患,提高胎儿监护仪使用的安全性及合格率。
Objective The research on the risk management and quality control of fetal monitor was carried out in this study. Meanwhile, the quality control special inspection work was carried out to reduce the clinical application risk of fetal monitor, in this process, the problems existing in the use of fetal monitor in the hospital were analyzed and the corresponding solutions were put forward. Methods Firstly, a perfect risk grade division assessment system was established and the quality control inspection plan was implemented. Then, the data that obtained by the inspection was evaluated and analyzed. Results Among the 142 sets of fetal monitors that were examined, 15 sets of them had error of fetal heart rate more than 5%, 26 sets appeared system time deviation, 17 system language changed from the default language English to other countries, 8 sets were illegal shutdown, 6 sets lost SOP operating procedures, and other test pass rate was 100%. Conclusion By conducting quality control inspection, the unsafe factors of fetal monitors is discovered, and the corresponding corrective measures and solutions are put forward. So, the risk of similar safety hazards could be reduced in future use of such devices, and the safety and pass rate of fetal monitor could be improved.
出处
《中国医疗设备》
2018年第2期165-167,177,共4页
China Medical Devices
基金
上海市卫生和计划生育委员会面上课题项目(201640314)
作者简介
通讯作者：路鹤晴，副研究员，设备科科长，主要研究方向为医疗设备质量管理。通讯作者邮箱：luheqing0811@126．com
