Disinfection Verification Tests

Disinfection verifications are used to verify the device manufacturer's disinfection instructions. Depending on the intended use of the device, verifications can be made to support high-level disinfection, medium-level disinfection and low-level disinfection.

This testing is particularly necessary when a device cannot be sterilized using high temperatures (e.g., steam sterilization, dry heat), is not compatible with EO or STERRAD sterilization methods, or does not require sterilization according to the Spaulding Classification. Thermal disinfection may need to be validated as part of the automatic washer-disinfector process or any disinfection process performed prior to terminal sterilization. EUROLAB It performs verifications according to AAMI TIR12, ANSI / AAMI ST58, ISO 15883 series, ISO 17664 standards.

• Food and Drug Administration 2015 / (R) 2017. Guidance for Industry and FDA Staff - Processing / Reprocessing of Medical Devices in Healthcare Settings: Validation Methods and Labeling. U.S. Department of Health and Human Services, Washington, DC
• AAMI TIR12: 201 Designing, testing and labeling reusable medical devices for reprocessing in healthcare facilities: A guide for device manufacturers. Medical Instrumentation Development Association, Arlington, VA.
• AAMI TIR30: 2 Summary of processes, materials, test methods and acceptance criteria for cleaning reusable medical devices. Medical Instrumentation Development Association, Arlington, VA.
• ANSI / AAMI ST58: 2013 Chemical sterilization and high-level disinfection in healthcare facilities. Medical Instrumentation Development Association, Arlington, VA.
• ANSI / AAMI ST79: 2 Comprehensive guide to steam sterilization and sterility assurance in healthcare facilities. Medical Instrumentation Development Association, Arlington, VA.
• Food and Drug Administration 2002. Class II Special Controls Guidance Document: Medical Washers and Medical Washer Disinfectors; Guidance for Medical Device Industry and FDA Review Personnel. FDA. Devices and Radiological Health Center, Washington, DC
• ISO 17664: 2 Processing of Medical Devices - Information to be provided by the medical device manufacturer for the processing of medical devices. International Organization for Standardization, Geneva, Switzerland.

For disinfection verifications, devices are inoculated at the worst place (s) of the device that opposed the disinfection process. Areas are inoculated with an appropriate concentration and type of organism and allowed to dry on the instrument. The disinfection process is carried out on each device, and then each device is rinsed with sterile water if applicable to the disinfection process. Each device is then removed and a bioburden reduction test performed to determine the number of organism (s) on the positive device compared to the disinfected devices, to generate the appropriate log reduction (s) for the process.

Accept conditions

High Level Disinfection

• 6-log reduction Mycobacterium spp.

 Intermediate Disinfection

• 6 log reduction Klebsiella pneumoniae
• 6 log reduction Pseudomonas aeruginosa
• 6 log reduction Staphylococcus aureus
• 6 log reduction Escherichia coli
• 3-log reduction Mycobacterium spp.

Low Level Disinfection:

• 6 log reduction Klebsiella pneumoniae
• 6 log reduction Pseudomonas aeruginosa
• 6 log reduction Staphylococcus aureus
• 6 log reduction Escherichia coli

EUROLAB, with its highly expert team and internationally accredited laboratories, Disinfection Verification Tests It performs all test, analysis, measurement, evaluation and report generation services completely and reliably.