S(p)oiler Alarm - Reusable Medical Devices, How to Proceed and What is New?

The requirements for reusable medical devices for submission on different markets and recertification has been increasing significantly during the last years. Each manufacturer has to describe a procedure risk based and appropriate for his reusable device of cleaning, disinfection and/or sterilisation respectively. The procedure has to be described in the instructions for use and the efficacy has to be shown by validation.

This webinar will present an overview on how to proceed in regard to classification, the choice of appropriate reprocessing procedures and description in the IFU. The presenters will show how to develop the testing strategy and the respective validation studies.

• Do I meet (new) requirements for reprocessing of MDR and FDA? Challenges and Pitfalls.
• Is my reprocessing procedure and description in the IFU appropriate and compliant with actual requirements?
• How to develop a testing strategy for the validation of the reprocessing procedure?
• What do I have to consider before starting validation studies?
• Workflow for cleaning, disinfection and sterilisation testing and new requirements e.g. AAMI ST98