Managing Human Factors in Reprocessing of Reusable Devices- Validation Considerations

The purpose of this webinar will be to provide quality assurance, design engineers, project engineers and all medical device manufacturers the knowledge and recommendations about how to manage the human factors in processing of reusable medical devices. Participants will learn: • Standards that govern medical device reprocessing, which include cleaning, disinfection and sterilization validations - Specifically, the new standards associated with human factors - Updates from the AAMI/FDA Round Table Discussion • Challenges inherent in device design for human factors • Considerations for cleaning and sterilization validations relevant to the practices of healthcare facilities • New recommendations for manufacturers, Instructions for Use (IFU) documents, etc. • Review of the manufacturer's responsibilities and considerations