Optimizing Sterilization Packaging through Root Cause Analysis: An Exploration into Sealing Defects of Paper-Plastic Pouches.

Abstract

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.