Cleaning of medical devices is a critical step for evaluating biocompatibility and controlling the microbiological load for sterilization, closely aligning to the ISO 10993-1 requirements. Patient safety is not only related to the specific materials that are being used, but also an understanding of the contaminants or residuals that can be introduced or observed during the manufacturing and handling processes.
The cleaning methods used need to be evaluated to ensure they don’t negatively impact either the biocompatibility or functional performance of the device. Additionally, cleaning validations ensure that the cleaning process removes sufficient levels of contaminants without introducing new contaminants. Cleanliness evaluations of devices can range from testing water purity used in manufacturing processes on a quarterly or monthly basis, confirming that cleaning agent residues are removed, and mitigation of environmental risks. Other areas include risk evaluations of materials used in a cleaning process, identification of potential contaminants throughout the manufacturing process, and ensuring pre-sterilization bioburden levels are sufficiently low.
Device cleanliness evaluations are not limited to manufacturing processes. Reusable medical devices undergo cleaning and disinfection, or sterilization, reprocessing procedures between patients. These reprocessing instructions for use (IFU) must also be validated to prevent any cross-patient contamination in healthcare settings.
Overall, it is the manufacturer's responsibility to provide clean devices to the user. The objective of the cleaning validation is to determine the effectiveness of the cleaning processes to remove physical, chemical, and microbial contaminants or residuals below a defined level. This can be handled with process cleaning steps designed to remove any contamination from the previous step, and a final cleaning before the parts are distributed. ISO 19227 is a guidance often used to evaluate orthopedic implants cleanliness and includes the methods listed below. Additional relevant methods are also outlined.
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