Ensuring Patient Safety with Reusable Medical Devices
For reusable medical devices, ensuring patient safety is a shared responsibility. The ability to render devices safe for re-use is subject to the demands of device design and function, clinical application, and reprocessing execution. Further, increased regulatory scrutiny, including the EU-MDR, mandates a robust and thoughtful approach for safe and effective reprocessing validations. This talk will provide an overview on the conduct of successful reprocessing validations with an emphasis on current regulatory requirements.