在国家生育政策调整背景下,上海市第一妇婴保健院年分娩量稳居全国前列,作为产前筛查核心设备的彩色超声诊断仪,其质量控制直接关乎胎儿畸形检出率及诊疗安全。为此,我院组建“孕眼圈”品管圈,整合设备科工程师、质控专员及临床医师共9人（圈能力值80%）,聚焦“提升彩色超声诊断仪质控检测合格率”主题,以5项核心指标（如最大探测深度、分辨率等）全达标为标准,运用PDCA-SDCA双循环模型及品管圈七大工具,系统破解设备检测合格率低（基线41%）的难题。通过实施影响图像质量因素的研究计划、组织培训并推广优化结果,完成34台设备全周期质控监测,合格率提升至81.8%（目标达标率104.1%,进步率99.5%）。本项目成功实现设备质控效能飞跃,构建了医工临床一体化质控体系,显著强化多学科协作能力。后续将持续深化预防性维护机制建设,推进医疗设备全生命周期精细化管理。

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.