Disinfection Validation

Disinfection is defined as killing microorganisms through the use of chemical disinfectants, or via thermal disinfection (the application of high temperature water).  Disinfection Validation is used to validate device manufacturer's disinfection instructions. A disinfection process is considered to be validated if the device is visually clean and a 6-log reduction in microorganisms can be shown.

The cleaning validation includes three steps:

• Contamination: Inoculate the medical device with an appropriate concentration and type of organism(s) and allow them to dry on the device;
• Disinfection: Disinfect the medical device using the recommended cleaning procedure from the manufacturer and then rinse it in sterile water;
• Post-processing effectiveness testing: Extract any remaining organism(s) on the device with a validated method and then perform bioload reduction testing on the extraction fluid to determine the number of organism(s) on the device. The establish of appropriate log reduction(s) helps to validate whether the process is appropriate to adequately disinfect the device.

STEMart helps manufacturer test and validate the labeling claims for disinfection of reusable medical devices in a health care facility.

Applicable Standards

• FDA Guidance Document Reprocessing Medical Devices In Health Care Settings: Validation Methods and Labeling
• AAMI TIR12 Designing, Testing and Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities
• AAMI TIR30 (ST98) A Compendium of Processes, Materials, Test Methods, and Acceptance Criteria for Cleaning Reusable Medical Devices
• AAMI ST58 Chemical Sterilization and High-Level Disinfection in Health Care Facilities
• AAMI ST79 Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities
• ISO 17664 Processing of Health-Care Products-Information to Be Provided by the Medical Device Manufacturer for the Processing of Medical Devices

Test Capabilities

• Low level disinfection (effective against most vegetative bacteria, some viruses and some fungi, but not tubercle bacilli, spores, or nonlipid viruses)
• Intermediate level disinfection (effective against tubercle bacilli, most viruses, fungi, and mycobacterium)
• High level disinfection (effective against most microbes, including bacterial spores)
• Thermal disinfection

STEMart provides adequate testing to demonstrate the efficacy of recommended disinfection instruction. If you want to learn more detail about our service, or would like to consult with the experts at STEMart, please feel free to contact us.