一种压力蒸汽灭菌过程挑战装置的性能研究

Performance study on a process challenge device for pressure steam sterilization

目的比较一种敷料型压力蒸汽灭菌测试包与不同长度及孔径的模拟管腔灭菌检测效果的一致性。方法采用内置5类化学卡的4种规格管腔(长度0.5~2.0 m、内径4~6 mm)模拟管腔医疗器械,并与敷料型灭菌化学测试包同时进行B1(低大气压)、B2(跨大气压)和B3(高大气压)循环的成功试验和失败试验,测试结果利用SPSS软件进行一致性检验。结果低大气压灭菌循环和跨大气压灭菌循环中,长度0.5~1.0 m、内径4~6 mm模拟管腔与敷料型灭菌化学测试包一致性检验的Kappa值为0.8~1.0。高大气压循环中,长度0.5~2.0 m、内径4~6 mm模拟管腔与敷料型灭菌化学测试包一致性检验的Kappa值均为1.0。结论在试验设定参数下,低大气压循环或跨大气压循环中,长度0.5~1.0 m、内径4~6 mm模拟管腔与敷料型灭菌化学测试包的测试结果一致性较好;在高大气压循环中,长度0.5~2.0 m、内径4~6 mm模拟管腔与敷料型灭菌化学测试包的测试结果一致性较好。

Objective To evaluate the consistency of sterilization monitoring outcomes between a steam chemical integrator test pack and simulated lumen devices with different lengths and diameters.Methods This study employed four distinct sizes of lumen devices(length 0.5 to 2.0 m,inner diameter 4 to 6 mm)with built-in type 5 chemical indicator to simulate tubular medical instruments.Alongside steam chemical integrator test pack,these lumen devices underwent successful and failed sterilization cycles under B1(sub-atmospheric pulsing),B2(trans-atmospheric pulsing),and B3(super-atmospheric pulsing)conditions.SPSS software was utilized for the analysis of experimental data consistency.Results In the sub-atmospheric pulsing and trans-atmospheric pulsing cycles,the consistency test between the simulated lumen devices(length 0.5-1.0 m,inner diameter 4-6 mm)and the steam chemical integrator test packs showed Kappa values of 0.8-1.0.In the super-atmospheric pulsing cycle,the consistency test between the simulated lumen devices(length 0.5-2.0 m,inner diameter 4-6 mm)and steam chemical integrator test packs yielded Kappa values of 1.0.Conclusion Under the experimental parameters of this study,in the sub-atmospheric pulsing and trans-atmospheric pulsing cycles,a good consistency was observed in the simulated lumen devices(length 0.5-1.0 m,inner diameter 4-6 mm)and the steam chemical integrator test packs.In the super-atmospheric pulsing cycle,the test results showed good consistency between the simulated lumen devices(length 0.5-2.0 m,inner diameter 4-6 mm)and the steam chemical integrator test packs.