This lecture provides an overview of Hospital Acquired Infections, human factors issues encountered in device design and in the health care facility, and how to perform a validation for a reusable medical device for use in the health care facility. Information on test procedures as well as US and EU regulatory requirements, including new guidance from FDA, will be provided.
- Review of current events
- Discuss human factors issues
- Overview of US and EU regulatory requirements
- Practical example of developing a validation testing strategy including implementation rationales and test choices