Department of Sterile Processing Nursing, West China Second University Hospital, Sichuan University/West China School of Nursing, Sichuan University, Chengdu, Sichuan, China (mainland).
Key Laboratory of Birth Defects and Related Diseases of Women and Children (Sichuan University), Ministry of Education, Chengdu, Sichuan, China (mainland).
Med Sci Monit. 2023 Jul 25;29:e940342. doi: 10.12659/MSM.940342.
BACKGROUND Paper-plastic sterilization pouches are essential in healthcare for preventing instrument contamination. However, sealing defects in these pouches can jeopardize patient safety. To address this issue, our study uses Root Cause Analysis (RCA), aiming to identify contributing factors to these defects and propose practical solutions. Through this, we aim to enhance the overall sterilization process. MATERIAL AND METHODS A retrospective analysis was conducted on 35,762 instruments sterilized and packaged in paper-plastic pouches at our hospital's Central Sterile Supply Department (CSSD) across two periods: July 2020 to June 2021 (pre-RCA, 17,563 instruments) and September 2021 to August 2022 (post-RCA, 18,199 instruments). We evaluated RCA scores, packaging personnel's perceptions of sealing quality, and sealing defect rates before and after RCA implementation. RESULTS Root causes for sealing defects included lack of a standardized inspection procedure, inadequately sized packing table, missed inspections, incorrect distribution procedures, inadequate staff training, and insufficient lighting through the pass-through window between storage and distribution rooms. Among these, lack of a standardized inspection procedure, small packing table size, and missed inspections were statistically significant risk factors (P<0.05). The sealing defect rate decreased from 0.15% pre-RCA implementation to 0.07% post-RCA implementation. CONCLUSIONS Implementing RCA has been shown to effectively enhance the CSSD staff's perception of sealing quality and significantly reduce the incidence of sealing defects in paper-plastic pouches. Thus, RCA serves as an invaluable tool for quality improvement in sterilization packaging processes.
纸塑灭菌袋在医疗保健中对于防止器械污染至关重要。然而，这些袋子的封口缺陷可能危及患者安全。为了解决这个问题，我们的研究使用根本原因分析（RCA），旨在确定导致这些缺陷的因素，并提出切实可行的解决方案。通过这样做，我们旨在提高整体灭菌过程的质量。
对我院中心供应室（CSSD）在两个时期使用纸塑袋包装和灭菌的 35762 件器械进行回顾性分析：2020 年 7 月至 2021 年 6 月（RCA 前，17563 件）和 2021 年 9 月至 2022 年 8 月（RCA 后，18199 件）。我们评估了 RCA 评分、包装人员对封口质量的看法以及 RCA 实施前后的封口缺陷率。
封口缺陷的根本原因包括缺乏标准化的检查程序、包装台尺寸不合适、漏检、分发程序不正确、员工培训不足以及储存和分发室之间的直通窗口照明不足。其中，缺乏标准化的检查程序、包装台尺寸小和漏检是统计学上的显著危险因素（P<0.05）。封口缺陷率从 RCA 实施前的 0.15%降至 RCA 实施后的 0.07%。
实施 RCA 已被证明可有效提高 CSSD 工作人员对封口质量的认识，并显著降低纸塑袋封口缺陷的发生率。因此，RCA 是提高灭菌包装过程质量的宝贵工具。
