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Disinfection Validation Testing for Reusable Devices

Agar Plates

Disinfection validations are used to validate device manufacturer’s disinfection instructions for reusable medical devices. Disinfection validation 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. 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 includes the use of applicable organisms, disinfection methods outlined by the manufacturer’s instructions for use, and log reduction evaluation. Validation testing may be needed when disinfection is an interim process prior to terminal sterilization, such as thermal disinfection in automated washer-disinfectors.

Applicable Standards

  • AAMI TIR12
  • ISO 15883 series
  • ISO 17664 series
  • FDA guidance documents

 Device Type Expertise*

  • Surgical Instruments
  • Orthopedics
  • Ear Nose Throat (ENT)
  • Dental
  • Respiratory
  • Flexible/Rigid Endoscopes and accessories; Transesophageal (TEE) probes
  • Robotics
  • Dialysis
  • Homecare
  • Capital Equipment
  • UV disinfection equipment and accessories

* Our scope of expertise is continuously expanding. A Nelson Labs expert can help develop methods and test plans for a variety of devices outside of the specifics listed above.

Study Outline

Inoculation: The devices are inoculated using appropriate organism(s) based on the disinfection level.  Nelson Labs experts can help to determine the appropriate methods by considering the device’s intended use and classification.

Disinfection: The devices will be disinfected using the worst-case disinfection procedures based on the manufacturers’ instructions for use. Disinfection procedures may include manual or automated methods (i.e. washer/disinfector or automated endoscope reprocessor). Nelson Labs can also accommodate any custom processes for validation.

Post-disinfection effectiveness testing:  After the devices are disinfected, they are extracted using a validated method to assess the effectiveness of the disinfection procedure. The extraction fluid is then evaluated to determine the presence of organism remaining on the device and calculate the log reduction(s). This testing validates the effectiveness of the disinfection procedure.

Testing Locations

  • Salt Lake City, UT, USA
  • Leuven, Belgium

Learn more about our locations and their certifications.