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.
Partnering with Element allows your company to mitigate risk knowing that we are working diligently to bring your safe product to market quickly. For more information about our microbiological analysis services or to request a quote, contact us today.
Ready to request a quote?
Our deliverable is certainty - high quality data, test reports and certificates that you can absolutely rely on when making decisions about your materials and compliance. Engage with an expert today.
More from Element
Medical Device Testing
As a comprehensive testing partner, you’ll enjoy the benefit of a single supplier source for all of your testing needs, from mechanical testing and environmental simulation to EMC and wireless device testing.
Medical Device Regulatory Services
Element’s regulatory advisors have 30 years of domestic and international regulatory consulting experience, specializing in handling the most complex challenges and partnering with you on the path to submission.
Chemical Analysis
Find out how Element's chemistry teams work with our customers to identify the contents, composition and quality of materials they develop and manufacture.
Reusable Medical Device Reprocessing Validation and Testing
Every Reusable Medical Device must be reprocessed before reuse to minimize risk of contamination; this includes cleaning and either sterilization or disinfection.