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Disinfection Validation for Reusable Devices

Disinfection validations are used to validate device manufacturer’s disinfection instructions. Validations may be performed to support high-level disinfection, intermediate-level disinfection, and low-level disinfection processes depending on the intended use of the device. This testing is specifically needed when a device can’t be sterilized using elevated temperatures (e.g., steam sterilization, dry heat), is not compatible with EO or STERRAD sterilization methods, or does not need to be sterilized according to the Spaulding Classification. Thermal disinfection may also need to be validated as part of the automated washer-disinfector process or any disinfection process performed prior to a terminal sterilization process.  Nelson Labs performs validations in compliance with AAMI TIR12, ANSI/AAMI ST58, ISO 15883 series, ISO 17664, and FDA guidance documents.

  • Food and Drug Administrati 2015/(R)2017. Guidance for Industry and FDA Staff –Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling. U.S. Department of Health and Human Services, Washington, D.C.
  • AAMI TIR12:201 Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for device manufacturers.  Association for the Advancement of Medical Instrumentation, Arlington, VA.
  • AAMI TIR30:2 A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices. Association for the Advancement of Medical Instrumentation, Arlington, VA.
  • ANSI/AAMI ST58:2013 Chemical sterilization and high level disinfection in health care facilities. Association for the Advancement of Medical Instrumentation, Arlington, VA.
  • ANSI/AAMI ST79:2 Comprehensive guide to steam sterilization and sterility assurance in health care facilities. Association for the Advancement of Medical Instrumentation, Arlington, VA.
  • Food and Drug Administrati 2002. Class II Special Controls Guidance Document: Medical Washers and Medical Washer-Disinfectors; Guidance for the Medical Device Industry and FDA Review Staff.  FDA.  Center for Devices and Radiological Health, Washington, D.C.
  • 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.

Testing Locations

 

Study Outline

For disinfection validations, devices are inoculated in the worst case location(s) of the device challenging to the disinfection process. The sites are inoculated with an appropriate concentration and type of organism(s) and allowed to dry onto the device. The disinfection process is performed on each device and then each device is rinsed in sterile water, if applicable to the disinfection process. Each device is then extracted and bioload reduction testing is performed to determine the number of organism(s) on the positive device compared to the disinfected devices to establish appropriate log reduction(s) for the process.

Acceptance Criteria:

High-Level Disinfection

  • 6-log reduction of Mycobacterium spp.

 Intermediate-Level Disinfection

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

If you have additional questions about disinfection validation services for reusable devices, or would like to consult with the experts at Nelson Labs, just send us a request or call us at +1 (801) 290-7500.