Cleaning Validation

Cleaning is defined as removal of soil residues with manual or automated method. It is always the first and necessary step in reprocessing of reusable medical device.

The cleaning validation includes three steps:

• Soiling: Inoculate the medical device with the appropriate test soil with clinically relevant markers such as protein, hemoglobin, carbohydrates, total organic carbon, and endotoxin under simulated actual surgical procedures;
• Cleaning: Clean the medical device using the recommended cleaning procedure from the manufacturer;
• Post-processing effectiveness testing: Extract any remaining test soil on the device with a validated method and then test the extraction fluid to determine residual amounts of test markers remaining on the device. The combination of this testing and visual inspection helps to validate whether the process is appropriate to adequately clean the device.

The cleaning process is considered to be validated if the following requirements are met:

• A visually clean device;
• 3-log reduction in microorganisms;
• Protein levels <6.4 ug/cm2;
• Hemoglobin< 2.2 ug/cm2;
• Carbohydrate <1.8 ug/cm2;
• Endotoxin <2.2 ug/cm2.

STEMart helps manufacturer test and validate the labeling claims for cleaning of reusable medical devices in a health care facility.

Applicable Standards

• FDA Guidance Document Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling
• AAMI TIR12 Designing, Testing and Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities
• AAMI TIR30 (ST98) A Compendium of Processes, Materials, Test Methods, and Acceptance Criteria for Cleaning Reusable Medical Devices
• ISO 17664 Processing of Health-Care Products-Information to Be Provided by the Medical Device Manufacturer for the Processing of Medical Devices
• ISO 15883 Washer-Disinfectors
• ASTM 2314 Standard Test Method for Determination of Effectiveness of Cleaning Processes for Reusable Medical Instruments Using a Micro-biologic Method (Simulated Use Test)

• Manual cleaning (Cleaning with or without use of brushes or specialized tools)
• Mechanical/automated cleaning (Ultrasonic or medical washers)

STEMart offers a full range of medical device cleaning validation services to validate manufacturers' cleaning instructions for reusable medical devices. If you want to learn more detail about our service, or would like to consult with the experts at STEMart, please feel free to contact us.