Evaluation of the Application Effectiveness of Defect Management Improvement Models in the Cleaning, Disinfection, and Packaging Management of Surgical Instruments in Central Sterile Supply Departments: A Before–After Study

Abstract

Background Central sterile supply departments (CSSDs) play a critical role in surgical patient safety by ensuring the effective cleaning and correct packaging of reusable surgical instruments. However, process defects may still occur and lead to rework, delays, or safety risks. This study evaluated the effectiveness of a closed-loop defect management improvement program for surgical instrument reprocessing in a CSSD. Methods We conducted a retrospective quasi-experimental before–after study comparing pre-intervention (January–June 2025, conventional management) and post-intervention (July–December 2025, closed-loop defect management improvement model) periods at West China Hospital. Data were collected through routine operational audits performed by trained human observers, including visual inspection, ATP testing, and protein residue testing, according to departmental standards. The intervention included standardized defect recording, structured analysis, corrective actions, feedback, and targeted training. Outcomes included qualified rates of cleaning and packaging, along with assembly errors, label errors, packaging integrity violations, and instrument damage. Results In 2025, 54,412 cleaned instruments and 6,488 packages were randomly inspected. Packaging tracking covered 215,927 packages (107,943 pre-intervention; 107,984 post-intervention). Compared with the pre-intervention period, the qualified rate of regular sampling tests increased from 97.99% to 99.76% (<0.05), and the packaging pass rate rose from 96.73% to 98.98% (<0.05). Assembly errors dropped from 43 to 15 cases, packaging damages from 57 to 6, and incorrect label information from 15 to 5 (all<0.05). Insufficient cleaning and instrument damage showed no significant difference. Conclusion In the CSSD, implementing the closed-loop defect management improvement model was associated with improved reprocessing quality and reduced packaging-related defects. Given that our pre-intervention quality rates already exceeded many published figures, we sought to determine whether implementing a closed-loop defect management improvement program could further reduce defect events and enhance reprocessing reliability, rather than merely meeting minimum standards.