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Cleaning Validation – Reuse Device

Nelson Labs offers a full range of medical device cleaning validation services to validate manufacturers’ cleaning instructions for reusable devices. This includes contamination, cleaning, and post-reprocessing effectiveness evaluations. 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 test complies with AAMI TIR12, AAMI TIR30, and the FDA guidance document “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling.” The reprocessing scientists at Nelson Labs actively serve on applicable AAMI committees and have expertise in creating appropriate worst-case testing conditions to help device manufacturers meet regulatory expectations.

Applicable Standards

  • AAMI TIR12
  • AAMI TIR30

Testing Locations

Study Outline

Cleaning validations evaluate the recommended cleaning procedure for a reusable device according to AAMI TIR12, AAMI TIR30, and the FDA guidance document “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling.” This information is needed 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 their own functionality and sterilization data, to the instructions for the end user.

Contamination: The devices are contaminated with organic material that may contain Escherichia coli, Geobacillus stearothermophilus, Staphylococcus aureus, or other appropriate microorganisms, along with other 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 contamination 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 soil for an appropriate time. The devices are removed from the soil and allowed to set for an appropriate time to simulate the wait time between use and reprocessing.

Positive device recovery: Extraction(s) will be performed to determine the number of viable organisms and/or additional markers on a positive device. Multiple extractions are often performed to obtain an extraction efficiency, a determination of how well organism(s) and marker(s) are recovered using the extraction method selected.

Cleaning process: The test devices will be cleaned using the recommended cleaning procedure 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 soil. The extraction fluid is then tested to evaluate bioload reduction and/or 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.

If you have additional questions about Cleaning 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.