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Scope Processing Validations – Reuse Device

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

Cleaning, disinfection, and sterilization validations must show that the processing is effective in removing soil components to predetermined levels specified in AAMI TIR30 (AAMI ST98: draft) and ISO 15883-5. Disinfection validations are generally performed to support high-level disinfection criteria 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 classification or support equipment that is used with these devices. Disinfection validations are typically needed for devices that cannot be sterilized using elevated temperatures (e.g., steam sterilization, dry heat) and may not compatible with ethylene oxide.

Nelson Labs performs validations in compliance with AAMI TIR30, AAMI TIR12, AAMI ST91 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 scope processing studies for both the scope and automated endoscope reprocessing (AER) equipment. Automated processes are preferred to reduce human factors in device processing to ensure a more consistent cleaning and disinfection process.

Applicable Standards

  • AAMI TIR12
  • AAMI TIR30 (AAMI ST98: draft)
  • AAMI ST91
  • AAMI ST58
  • ISO 17664
  • ISO 15883 series
  • Guidance for Industry and FDA Staff – Reprocessing Medical Devices in Healthcare Settings: Validation Methods and Labeling

Testing Locations

 

Study Outline

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

For the disinfection validation the following levels are chosen as appropriate depending on the devices’ s criticality and use in the clinical setting. Scopes are predominantly processed through high-level disinfection however equipment supporting the use of the scope can be processed through intermediate- or low-level disinfection.

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 Scope Processing Validation services, or would like to consult with the experts at Nelson Labs, just send us a request or call us at +1 (801) 290-7500.