Against the backdrop of national fertility policy adjustments, Shanghai First Maternity and Infant Hospital ranks among the top in annual delivery volumes nationwide. As a core device for prenatal screening, the quality control of color ultrasonic diagnostic equipment directly impacts fetal anomaly detection rates and clinical safety. To address this, we established the "Pregnancy Eye Circle" quality control circle (QCC), integrating 9 multidisciplinary members including biomedical engineers, quality controllers, and clinicians (circle competence score: 80%). Focusing on "improving the pass rate of color ultrasonic diagnostic equipment quality control inspections", we defined 5 critical performance indicators (e.g., maximum depth and resolution) as mandatory compliance standards. Utilizing the PDCA-SDCA dual-loop model and seven QCC tools, we systematically addressed the pass rate deficiency (baseline 41%). Through image quality factor analysis, standardized training programs, and process optimization implementation, we conducted full-cycle quality monitoring on 34 ultrasound systems, achieving an upgraded pass rate of 81.8% (target attainment ratio: 104.1%; improvement rate: 99.5%). This project demonstrated significant enhancements in equipment quality control efficiency, established an integrated medical-engineering-clinical quality management framework, and strengthened multidisciplinary collaboration capabilities. Future initiatives will focus on refining preventive maintenance protocols and advancing lifecycle management for medical devices.
LU Sijie
,
ZHENG Jiaxin
,
YAN Hao
,
ZHU Zhigang
. Application of quality control circle activities in quality management of color ultrasonic diagnostic equipment[J]. Surgical Research and New Technique, 2025
, 14(3)
: 274
-279
.
DOI: 10.3969/j.issn.2095-378X.2025.03.017
[1] 郑青. 医疗设备报废的问题及对策[J]. 医疗装备,2018,31(3):97-99.
[2] 毛燕正. 医疗设备的报废管理及实践[J]. 医疗装备,2018,31(4):71-72.
[3] 向华,付孝梅,张和华,等. 医院医疗设备报废质量管理研究[J]. 中国医学装备,2016,13(11):122-125.
[4] 孟世和. B超诊断仪图像质量下降常见故障的诊断与修复[J]. 临床超声医学杂志,2010,12(1):71-72.
[5] 余冬明. B超诊断仪图像质量降低故障的维修分析[J]. 医疗装备,2015,28(7):143.
[6] 陈曦. 胎儿颈后透明层厚度联合四维彩超在早期产前胎儿畸形筛查中的准确率评估分析[J]. 中国医疗器械信息,2025,31(3):98-100.
[7] 李春严,吴丽花,吴玲玲,等. 品管圈活动在静脉血栓栓塞症高危患者出血风险评估中的应用效果[J].血管与腔内血管外科杂志,2023,9(1):108-112.
[8] 国家食品药品监督管理总局.医疗器械使用质量监督管理办法[J]. 中华人民共和国国务院公报,2016(2):73-77.
[9] 杨风辉,潘文琴. 医学工程部门落实《医疗器械临床使用管理办法》[J]. 解放军医院管理杂志,2021,28(10):975-977.
[10] 贾邹赛,柏荣庆,杨艳. 新修订《医疗器械监督管理条例》解读[J]. 中国医疗器械信息,2022,28(5):4-6.
[11] 谭换仪. 新形势下持续质量提升的医疗质量管理应用研究[J]. 黑龙江中医药,2024, 53(3):124-126.
[12] 谢杲. 彩超设备探头相关可疑医疗器械不良事件的分析[J]. 医疗装备,2023,36(17):92-94.
[13] 王伟祥,朱红俊,张强,等. PDCA循环工具在降低临床检验标本不合格率中的应用[J]. 中国卫生检验杂志,2022,32(22):2807-2809.
[14] 张戌,李向东,刘蓥灿,等. B型超声诊断仪检定方法的分析[J]. 中国医学装备,2015, 12(8):44-47.
[15] 杨广宇. 浅谈医疗机构对彩超的保养和检测[J]. 计量与测试技术,2017,44(1):66-67.
[16] 张晓峰,曹扬,邹庆辉,等. 超声质量控制管理方案探究[J]. 中国医疗设备,2017,32(10):135-137.
[17] 陈庆,沙益夫,尤若宁,等. 超声诊断仪在临床应用上的质量安全研究[J]. 医疗卫生装备,2017,38(11):94-96.
[18] 杨玲,钱晓凌,叶剑锋. B超计量检定的方法及结果[J]. 医疗装备,2013,26(01):28-29.
[19] 周学武,杨泽楠,孙菊江,等. 基于层次分析法的医疗设备报废评估模型研究[J]. 医疗卫生装备,2022,43(8):59-63.
[20] 曹侃,徐勤,邢昊昱. 医疗设备报废相关问题的思考与建议[J]. 医院管理论坛,2016,33(2):62-63.
[21] 尹军,陈维平,刘福彬. 医院医疗设备评估探讨[J]. 中国药物警戒,2011,8(7):416-418.
[22] 贾立民,张鹏飞,张鹏. 医疗设备报废评定标准及残值利用[J]. 中国医学装备,2016,13(8):102-105.