Effectiveness of Super Rapid-Readout Versus Rapid-Readout Biological Indicators in Steam Sterilization: A Case Study in the Central Sterile Supply Department, Mae Fah Luang University Medical Center Hospital
Keywords:
Super Rapid readout biological indicator, Steam sterilization, CSSD, Sensitivity, Sterilization failure detectionAbstract
Background: Biological indicators (BIs) are essential tools for verifying the effectiveness of steam sterilization processes, particularly in Central Sterile Supply Departments, where accurate and timely confirmation of sterilization cycles is required. Objective: This study aimed to compare the effectiveness of a 5-minute super rapid-readout biological indicator and a 24-minute rapid-readout biological indicator during pre-vacuum steam sterilization at 134 °C in the Central Sterile Supply Department of Mae Fah Luang University Medical Center Hospital. Methods: This comparative experimental study evaluated two types of biological indicators: Brand A, a 5-minute super rapid-readout BI, and Brand B, a 24-minute rapid-readout BI. A total of 600 BI samples were tested. The experiment was conducted under three steam exposure durations: 1, 3, and 5 minutes, representing suboptimal, marginal, and adequate sterilization conditions, respectively. The proportions of positive and negative results between the two products were compared at each exposure duration. Statistical significance was set at p < 0.05. Results: In the 1-minute cycle,
representing a suboptimal sterilization condition, both biological indicators yielded 100.00% positive
results, with no statistically significant difference between Brand A and Brand B. In the 3-minute cycle, representing a marginal condition and a critical point for assessing BI sensitivity, Brand A yielded 95.00% positive results, whereas Brand B yielded 85.00%. This indicated a 10-percentage-point difference in
sensitivity, which was statistically significant (p = 0.032). In the 5-minute cycle, which represents an adequate sterilization condition, both biological indicators yielded 100.00% negative results, indicating specificity under the experimental conditions. Conclusion: The 5-minute super rapid-readout biological indicator demonstrated significantly higher sensitivity than the 24-minute rapid-readout biological indicator in the 3-minute marginal cycle, which is a critical condition for detecting steam sterilization process failure. These findings support the potential suitability of super-rapid-readout BIs for load-by-load quality monitoring in settings that require rapid, highly sensitive verification. However, further studies are needed to evaluate workload, cost, and occupational health implications.
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