Abstract: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.
苏琦,路鹤晴,严浩. 胎儿监护仪风险管理及质量控制实践研究[J]. 中国医疗设备, 2018, 33(2): 165-167.
SU Qi, LU Heqing, YAN Hao. Study on the Practice of Fetal Monitor Risk Management and Quality Control. China Medical Devices, 2018, 33(2): 165-167.