American journal of infection control · 2026
Performance of hydrogen peroxide gas plasma and vaporized hydrogen peroxide sterilizers under long narrow lumen challenge conditions.
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Gao Lei, Mao Rui, Zhao Qing, Li Jin, Qin Ruixue, Xiong Xuan, Wen Lin
Аннотация
BACKGROUND: Long narrow lumens remain challenging for low-temperature sterilization because sterilant must reach the distal lumen endpoint. We compared hydrogen peroxide gas plasma and vaporized hydrogen peroxide systems under matched lumen challenge conditions.
METHODS: Polytetrafluoroethylene process challenge devices combined lumen lengths of 2, 4, and 8 m with internal diameters of 0.8, 1.0, and 1.5 mm. Each condition was tested in 5 standard cycles per system, yielding 90 biological indicator observations. Success proportions and between-system percentage-point differences are reported with 95% confidence intervals (CIs).
RESULTS: Overall success was 33/45 (73.3%; 95% CI 59.0-84.0) for ASP/STERRAD 100NX and 36/45 (80.0%; 95% CI 66.2-89.1) for STERIS V-PRO Max; the difference was 6.7 percentage points (95% CI -10.8 to 23.7). At 8 m, success was 6/15 (40.0%) and 8/15 (53.3%), respectively; the difference was 13.3 points (95% CI -20.2 to 43.1). The 8 m × 0.8 mm condition was most challenging. Chemical and biological indicator results diverged in the vaporized hydrogen peroxide system.
DISCUSSION: Distal biological indicator results varied mainly with lumen geometry.
CONCLUSIONS: Local validation should consider combined lumen length and diameter and include distal biological monitoring for challenging lumen configurations.
METHODS: Polytetrafluoroethylene process challenge devices combined lumen lengths of 2, 4, and 8 m with internal diameters of 0.8, 1.0, and 1.5 mm. Each condition was tested in 5 standard cycles per system, yielding 90 biological indicator observations. Success proportions and between-system percentage-point differences are reported with 95% confidence intervals (CIs).
RESULTS: Overall success was 33/45 (73.3%; 95% CI 59.0-84.0) for ASP/STERRAD 100NX and 36/45 (80.0%; 95% CI 66.2-89.1) for STERIS V-PRO Max; the difference was 6.7 percentage points (95% CI -10.8 to 23.7). At 8 m, success was 6/15 (40.0%) and 8/15 (53.3%), respectively; the difference was 13.3 points (95% CI -20.2 to 43.1). The 8 m × 0.8 mm condition was most challenging. Chemical and biological indicator results diverged in the vaporized hydrogen peroxide system.
DISCUSSION: Distal biological indicator results varied mainly with lumen geometry.
CONCLUSIONS: Local validation should consider combined lumen length and diameter and include distal biological monitoring for challenging lumen configurations.