Nelson Labs specializes in flexible scope processing validations for both the scope and automated endoscope reprocessing (AER) equipment. Nelson Labs has been conducting validation testing for over 20 years, actively participates in standard committees, and develops appropriate test methods that are recognized by regulatory bodies. Flexible scopes used for diagnostic and therapeutic procedures require validated processing instructions to reduce the risk of healthcare associated infections (HAIs). Manufacturers are responsible for validating the processing instructions outlined in their instructions for use (IFU) to ensure that, when properly followed in the clinical setting, the device is safe for its intended use or reuse.
Nelson Labs has partnered with Healthmark Industries to offer a Flexible Endoscope Sampling Kit. This was developed alongside the Center for Disease Control (CDC) with a purpose of monitoring and reporting objective microbiological results from processed clinical scopes.
Applicable Standards
- AAMI TIR12
- AAMI TIR99
- 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
Study Outline
Cleaning validations evaluate the manufacturers’ recommended cleaning procedure for a reusable device. This validation is necessary to ensure that once the device has been used, it can be properly cleaned prior to disinfection or sterilization and reuse. It is the responsibility of the manufacturer to apply these data, along with functionality, end-of-life, and disinfection/sterilization data, to the IFU. Nelson Labs experts are available to help manufacturers develop a cleaning procedure to be validated for their IFU.
Soiling: The devices are soiled using an appropriate test soil with clinically relevant markers such as protein, hemoglobin, total organic carbon, and carbohydrates. Nelson Labs experts can help to determine the appropriate test soils and soiling method by considering the device’s intended use and worst-case wait time between uses.
Cleaning: The devices will be cleaned using the worst-case cleaning procedures based on the manufacturers’ IFU. Cleaning procedures may include manual, automated (automated endoscope reprocessor). Nelson Labs can also accommodate custom processes for validation.
Post-cleaning effectiveness testing: After the devices are cleaned, they are extracted using a validated method to assess the effectiveness of the cleaning procedure. The extraction fluid is then evaluated to determine the presence of residual soil components remaining on the device. This testing, combined with visual inspection, helps to validate the effectiveness of the cleaning procedure.
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), or is not compatible with EO or STERRAD sterilization methods.
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’ IFU. Disinfection procedures may include manual or automated methods (automated endoscope reprocessor). Nelson Labs can also accommodate 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
Learn more about our locations and their certifications.
Contact Us
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.
