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Medical devices need to be cleaned thoroughly and effectively to ensure their safety in use. Reusable devices (such as surgical tools etc.) require reprocessing (cleaning and disinfection/sterilization) between each use. To ensure the effectiveness of such reprocessing methods, manufacturers are required to validate their cleaning and disinfection/sterilization processes as part of the device instructions for use (IFU). The webinar will focus on key factors that should be considered when developing and validating the cleaning process.
Craig Donald, Head of Chemistry, Lucideon, said: “Significant risks of nosocomial infection have driven improved requirements for the reprocessing instructions for reusable medical devices. The FDA now requires device manufacturers to validate not only the recommended disinfection and sterilization processes but also the cleaning process.
“We’ll cover the range of considerations required in addition to relevant test methods used to perform appropriate cleaning validations. Each individual device has a unique design and application and both of these factors, amongst others, influence the required cleaning process. This should be of interest to any reusable medical device manufacturer wishing to bring a product to market.”
Lucideon provides extensive testing and consultancy services to the healthcare sector. Its Medical Device offerings include orthopedic implant testing and development consultancy, materials selection, failure analysis and cleanliness validation. Lucideon’s VALIDATA service provides quantitative, on-going, third party cleanliness validation to ensure product safety.
To register for the webinar, click here.
