Medical Device 2012 - FDA Concerns on Alarm Standards and Safety

This webinar on alarms in patient monitoring devices will show how you can address FDA concerns regarding alarm standards and safety. You will understand use, misuse, and the way users react or not react to alarms and how you can design new devices and re-design current products using robust human engineer

Why Should You Attend:

FDA is seeking to reduce “alarm fatigue" in hospitals by intensifying its pre-market review. What can you do?

Areas Covered in the Seminar:
- Review of FDA alarm related recalls.
- Understanding potential harm scenarios.
- Translating harm scenarios into good design specifications.
- Key design techniques to maximize response to alarms.
- Verifying alarm effectiveness.
- Training and labeling requirements.
- Retrospective validation.ing principles.