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Endoscopes and Scope Validations – Reuse Device

Diagnostic equipment reprocessed in clinical facilities needs  properly validated reprocessing instructions to reduce the risk of cross-contamination or spread of disease between patients or with health care practitioners. Manufacturers have a responsibility to validate their reprocessing instructions to ensure that, when properly followed in the clinical setting, the device is safe for its intended use or reuse.

Cleaning validations must show that the procedure is effective in removing soil components to predetermined levels specified in AAMI TIR30. Disinfection validations are generally performed to support high-level disinfection for these types of devices; however, intermediate-level disinfection or low-level disinfection processes may be appropriate depending on the intended use of the device criticality classifcation.

Disinfection validations are typically needed as these devices cannot be sterilized using elevated temperatures (e.g., steam sterilization, dry heat) and may not compatible with ethylene oxide or Sterrad sterilization methods. Nelson Labs performs validations in compliance with AAMI TIR30,, AAMI TIR12, and FDA guidance documents. As this is an evolving area of reprocessing, Nelson Labs is constantly working with US FDA regulators and manufacturers to ensure that the most current guidance and best practices are employed.

Nelson Labs specializes in endoscope and scope reprocessing studies for both the device or scope and automated endoscope reprocessing (AER) equipment. Automated processes are preferred to reduce human factors in device reprocessing to ensure a more consistent cleaning or disinfection process.

Applicable Standards

  • AAMI TIR12
  • AAMI TIR30
  • Guidance for Industry and FDA Staff – Reprocessing Medical Devices in Healthcare Settings: Validation Methods and Labeling

Testing Locations

Study Outline

For Endoscope and Scope Cleaning Validations, devices are soiled with a clinically relevant test soil and allowed to dry. The manufacturer’s recommended cleaning procedure is performed on the device and then the devices are extracted. The sample extracts are analyzed for the selected organic markers (i.e. protein, hemoglobin, carbohydrates) to determine the efficacy of the cleaning procedure.

High-level disinfection: This test requires a 6-log reduction of Mycobacterium spp.

Intermediate-level disinfection: This test requires a 6-log reduction of four common vegetative organisms (i.e., Klebsiella pneumoniae, Pseudomonas aeruginosa, Staphylococcus aureus and Escherichia coli) and a 3-log reduction of Mycobacterium spp.

Low-level disinfection: This test requires a 6-log reduction of four common vegetative organisms (i.e., Klebsiella pneumoniae, Pseudomonas aeruginosa, Escherichia coli and Staphylococcus aureus).

If you have additional questions about Endoscope / Scope Validation services for reuse 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.