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. The scope processing validation is no different, as it requires the manufacturer to possess a sterile cleaning procedure, or else the diagnostic device cannot be used in a medical setting.
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.
We also offer a Flexible Endoscope Sampling Kit with a purpose of monitoring and reporting objective microbiological results from processed clinical scopes. Based on intended use and internal procedures and policies, the health care facility should determine when microbial contaminants, if detected, require the scope to have additional processing, testing, or be quarantined.
Applicable Standards
- AAMI TIR12
- ANSI/AAMI ST98*
- 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
* As of August 2022, AAMI TIR30 has been replaced by ANSI/AAMI ST98. Learn more about this change in our comprehensive blog post.
