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Endoscopes and Scope Validations – Reuse Device

Diagnostic equipment reprocessed in clinical facilities needs to be properly validated 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.

Endoscope and scope cleaning and disinfection validations are used to validate the manufacturer’s disinfection instructions which require that each device or component be disinfected separately. Validations are generally performed to support high-level disinfection for these device types; however, intermediate-level disinfection or low-level disinfection processes may be appropriate dependent on device intended use and criticality.

Scope disinfection validations are typically needed as these devices cannot be sterilized using elevated temperatures (e.g., steam sterilization, dry heat) and are generally not compatible with EtO or Sterrad sterilization methods. Nelson Labs performs validations in compliance with AAMI TIR12, ANSI/AAMI ST81, 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 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

Testing Locations

Study Outline

For Endoscope and Scope Disinfection Validations, devices are inoculated with an appropriate concentration of organism(s) and allowed to dry. The cleaning and disinfection procedure is performed on each device and then the devices are rinsed in sterile water. Each device is then extracted and bioburden is performed on the extracts to determine the number of organism(s) on the positive device compared to the disinfected devices.

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.