This study aimed to explore the application effect of a traceability management system in the centralized treatment of infection risk associated with orthopedic loaned medical instruments in the central sterile supply department (CSSD). In this retrospective comparative study, orthopedic loaned medical devices used in orthopedic surgical procedures, recovered by the CSSD of our hospital, and centrally reprocessed between February 2021 and February 2022 were included. All eligible devices identified during this predefined study period were retrospectively screened and analyzed. Devices managed with routine process management were included in the control group, whereas those managed with the traceability management system were included in the experimental group. The centralized reprocessing workflow included device recycling, cleaning, packaging, sterilization, and distribution. The qualification rates of packaging, cleaning, sterilization, and functional integrity, as well as the device number loss rate, label accuracy rate, and clinical department satisfaction, were compared between the 2 groups. A total of 2000 orthopedic loaned medical devices were analyzed, including 1000 in the control group and 1000 in the experimental group. Compared with the control group, the experimental group showed higher qualification rates for packaging (97.5% vs 92.5%) and sterilization (99.2% vs 94.5%), a lower device number loss rate (0.3% vs 8.9%), and higher clinical department satisfaction (94.0% vs 78.0%) (all P < .001). Process quality control management based on a traceability management system can improve the accuracy and reliability of cleaning, disinfection, and sterilization of orthopedic loaned medical instruments in the CSSD.
Zhu et al. (2026) studied this question.