Abstract: Objective: To evaluate the effects of the whole-process quality traceability information management for rental medical devices. Methods: The rental medical devices were convenient selected and divided into control group (n= 3959) and experimental group (n=3402). The control group adopted the conventional manual traceability management method, and the experimental group adopted the whole-quality traceability information management system. The two groups were compared in terms of the qualified rate of printing labels, the qualified rate of parameter records, the qualified rate of cleaning quality, the time spending on information inquiry and reception. The staff satisfaction of operation room and Central Sterile Supply Department were also investigated. Results: The qualified rate of printing labels, the qualified rate of parameter records, the qualified rate of cleaning quality in the experimental group were significantly higher than those in the control group. The staff satisfaction of nurses from the operation room and Central Sterile Supply Department were 96.75% and 95.00%, respectively. Conclusion: The whole-process quality traceability information management for rental medical devices can not only realize real-time monitoring of quality, but also improve the professional level of disinfection and sterilization, improve the work efficiency, and the satisfaction of staff.

Key words: rental medical devices; quality traceability; informatization; Central Sterile Supply Department