Performance study on a process challenge device for pressure steam sterilization
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.
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