Haas Bruno, Soto Kelly J, Day Dana S, Roy Alexander C, Gagnon Marie-Claude, Alt Jodi R, Labrie Philippe
STERIS Canada ULC, 490, Boulevard Armand-Paris, Quebec City, QC, G1C 8A3, Canada.
STERIS Corporation, Mentor, OH, USA.
BMC Res Notes. 2020 Mar 10;13(1):140. doi: 10.1186/s13104-020-04978-7.
Reprocessing reusable medical devices is crucial in the healthcare industry. To ensure patient safety, strict standards are dictated to validate thermal disinfection in automated washer-disinfectors. The United States Food and Drug Administration (FDA) has specific recommendations on the vegetative bacterial challenge but comparatively vague guidance on the use of a thermophilic Mycobacterium strain for thermal disinfection studies. This study aims to compare thermal resistance of Mycobacterium hassiacum and Mycobacterium terrae and determine which strain is suitable for medical device thermal disinfection validation testing in automated washer-disinfectors.
Thermal resistance was demonstrated in vitro by calculating D-values for each strain at different exposure temperatures, and correlated with actual in situ processing conditions. M. terrae was completely killed (> 7 log reduction) at temperatures above 68 °C, with D-values between 46.6 and 27.8 s at temperatures between 59.5 and 67.2 °C. M. hassiacum was completely killed (> 8 log reduction) at temperatures above 75 °C, with D-values between 82.1 and 21.7 s at temperatures ranging between 69.2 and 73.6 °C. In vitro results were correlated in a washer-disinfector performance validation setup.
可重复使用医疗设备的再处理在医疗行业至关重要。为确保患者安全，制定了严格标准以验证自动清洗消毒器中的热消毒效果。美国食品药品监督管理局（FDA）对营养型细菌挑战有具体建议，但在用于热消毒研究的嗜热分枝杆菌菌株的使用方面指导相对模糊。本研究旨在比较哈氏分枝杆菌和地分枝杆菌的热抗性，并确定哪种菌株适用于自动清洗消毒器中医疗设备热消毒验证测试。
通过计算各菌株在不同暴露温度下的D值在体外证明了热抗性，并与实际原位处理条件相关。地分枝杆菌在68℃以上温度下被完全杀灭（>7个对数减少），在59.5至67.2℃温度下D值在46.6至27.8秒之间。哈氏分枝杆菌在75℃以上温度下被完全杀灭（>8个对数减少），在69.2至73.6℃温度范围内D值在82.1至21.7秒之间。体外结果在清洗消毒器性能验证设置中得到了关联。
