Disinfection process validation
Disinfection Process Validation
Disinfection process test provided by SMP GmbH of Germany
Low-Level Disinfection
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S. aureus ATCC 6538
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P. aeruginosa ATCC 15442
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E. coli K12 NCTC 10538
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Kl. Pneumoniae ATCC 13883
High-Level Disinfection
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M.Terrae ATCC 15755
Evaluation of manual disinfection process
The medical device under test is inoculated with a defined amount of bacterial suspension, and after drying, the medical device is subjected to a disinfection process (wiping or immersion disinfection).
Assess contaminated sites for viable microorganisms using an appropriate recovery process. At the same time, positive controls (inoculated but not disinfected) and negative controls (uninoculated but washed and disinfected) of unsterilized test samples are also evaluated.
Evaluation of automatic hot water disinfection process
SMP GmbH also offers validation testing of automated hot water disinfection processes with ISO 15883 compliant washer-disinfectors.
"For hot water disinfection processes, a particular temperature can be expected to have a predictable lethal effect on a standardized population of organisms, using the lethality of the particular process at different temperatures for cycles. The overall lethality can be assessed and achieved by the A0 value, which is expressed as the equivalent exposure time at a given temperature.
Standards and guidelines
E1837: Standard test method to determine efficacy of disinfection processes for reusable medical devices (2014)
E1054: Standard Test Methods for Evaluation of Inactivators of Antimicrobial Agents1
FDA Guidance: Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling June 9, 2017
FDA Guidance: Medical washers and medical washer- disinfectors February 7, 2002