What is Cleaning Validation Testing for Reusable Devices?
Nelson Labs offers a full range of medical device cleaning validation services to validate manufacturers’ cleaning instructions for reusable devices. This includes soiling, cleaning, and post-processing effectiveness testing. Simulated-use testing practices are employed to simulate actual surgical procedures rather than direct inoculation methods. Options are available to use validated or customized test soils to create clinically relevant conditions. This testing complies with AAMI TIR12, AAMI TIR30 (ST98: draft), ISO 17664, and the FDA guidance document “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling.” The processing scientists at Nelson Labs actively serve on applicable AAMI, ISO, and ASTM committees and have expertise in creating appropriate worst-case testing conditions to help device manufacturers meet regulatory expectations. View our Reusable Device Cleaning Recommendations.
- AAMI TIR12
- AAMI ST98*
- ISO 17664
- ISO 15883 series
- ASTM 2314
* As of August 2022, AAMI TIR30 has been replaced by ANSI/AAMI ST98. Learn more about this change in our comprehensive blog post.
Cleaning validations evaluate the recommended cleaning procedure for a reusable device according to AAMI TIR12, AAMI TIR30, ISO 17664, and the FDA guidance document “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling.” This validation is necessary to assure that once the device has been used, it can be properly cleaned. It is the responsibility of the manufacturer to apply this data, along with functionality and sterilization data, to the instructions for the end user.
Contamination: The devices are soiled using the appropriate test soil with clinically relevant markers such as protein, hemoglobin, carbohydrates, total organic carbon, and endotoxin. The device’s intended use and wait time between patient use and cleaning are considered in determining the soiling method. The devices are often sprayed, handled with soiled gloves, and/or immersed in the test soil. All movable parts may be actuated to simulate clinical use and then left in contact with the test soil for an appropriate time. The devices are then removed from the soil and allowed to set for an appropriate time to simulate the wait time between patient use and processing.
Positive device recovery: Extraction(s) will be performed to determine residuals on a positive device. Multiple extractions are performed on the device to obtain an extraction efficiency, this information gives determination of how well the marker(s) are recovered using the extraction method selected.
Cleaning processes: The test devices will be cleaned using the recommended cleaning procedures from the manufacturer. A manual process might involve immersing devices in detergent prepared according to the detergent manufacturer’s recommendations. A soft bristled brush may be used to aid in soil removal, paying particular attention to crevices and hard-to-clean areas. Some devices may need to be subjected to a mechanical step that may include ultrasonic cleaning in an enzymatic detergent. Nelson Labs is also capable of performing fully automated validations in common health care washer-disinfectors.
Residual testing: After the devices are cleaned, they are extracted using a validated method to remove any remaining test soil. The extraction fluid is then tested to evaluate residual amounts of test markers remaining on the device. This testing, combined with visual inspection, helps to validate that the process was appropriate to adequately clean the device.
- Salt Lake City, UT, USA
- Leuven, Belgium
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If you have additional questions about Cleaning Validation services for reusable 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.