Guidance for Cleaning, Disinfection and Sterilization of Reusable Medical Devices скачать в хорошем качестве

Guidance for Cleaning, Disinfection and Sterilization of Reusable Medical Devices

Presenters: Stefanie Roberfroid and Melissa Galle All reusable devices should contain specific instructions for cleaning, disinfecting and/or sterilization of the device. In order to be compliant with global regulations, manufactures should have their instructions for use (IFU) validated to ensure patient safety and mitigating cross contamination. It is recommended to validate at least one method for each applicable stage of reprocessing of the medical device. During this 45-minute webinar anyone involved in the manufacturing of reusable medical devices (from Design R&D teams to people working in Quality Assurance or Regulatory) will learn more about: The full processing cycle (What is reprocessing and what devices should be considered for this type of testing) How to comply with the new EU MDR The validation of a cleaning procedure (To what extend the device design can impact the validation protocol) Methods for disinfection or sterilization instructions The importance of cytotoxicity testing after a reprocessing cycle