Cleaning and Sterilization Validation of Reusable Medical Devices
Cleaning Validation of Reusable Medical Devices
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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 patient safety. To demonstrate the effectiveness of such reprocessing methods, manufacturers are required by regulatory authorities to validate their cleaning and disinfection/sterilization processes included in the device instructions for use (IFU).
We provide testing, cleaning and sterilization services for a wide range of medical devices. All products are inoculated using appropriate test soils and biological indicators. Following cleaning, advanced analytical techniques are employed to ensure the cleanliness of the device. We provide validation for both manual and automatic cleaning methods and design validation procedures specifically to meet the requirements of each device.
Our chemical and microbiological testing facilities coupled with our long-standing experience working with medical devices make us the ideal partner for such validations. We work in accordance with the following standards and guidance documents, AAMI TIR30:2011, AAMI TIR12:2010, ISO 17665-1, ISO 11138-1, ASTM E1766-15 among others so you can be confident that our experts can assist you with your regulatory submissions. We can perform such validations on the finished product or work with you throughout the development phase to assist device design and material selection.