Research on the Entire Process Parameter Validation and Quality Control System for Sterilization of Special Luminal Devices Based on Risk Assessment
Objective: To compare the temperature and time characteristics of specialized lumen instruments versus standard dressing test kits throughout the pre-vacuum pressure steam sterilization process, and to identify major risks during sterilization and drying stages. Methods: Three sterilizers from two campuses of a tertiary hospital were selected, using non-metallic lumens, metallic endoscope lumens, and a 7 kg standard dressing test kit as subjects. Miniature probes were placed inside the lumens or at the center of the test kits, with parameters for the initial pulse phase, heating phase, sterilization maintenance phase, and drying phase recorded under maximum challenging loading conditions. Results: During the initial pulse phase, the heating rates of standard test kits across all three devices were slower than those of lumen instruments. After entering the heating and sterilization maintenance phases, all load parameters converged, with most measurement points recording sterilization temperatures between 134.6–135.4 ℃ and exposure times meeting specified requirements. Significant differences in drying performance were observed among brands: Brand C exhibited the shortest average drying time (1286 s), while Non-Metallic Lumen 1 showed the highest average temperature (92.9 ℃), indicating that localized high temperatures do not necessarily equate to adequate drying, and wet-dress risk may be associated with insufficient removal of residual steam or condensation. Conclusion: Under the loading conditions and sterilization protocols studied, specialized lumen instruments did not demonstrate higher sterilization failure risks compared to standard dressing kits; when standard dressing test kits met sterilization parameters, lumen instruments typically also satisfied required sterilization temperatures and durations. Quality control should shift from solely focusing on compliance to balancing sterilization and drying processes, with particular emphasis on optimizing loading management for non-metallic lumens, refining drying procedures, and enhancing tracking of wet-dress conditions.
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