Event:
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Designing Medical Device Alarms to Mitigate New FDA Concerns
- Hosted By:
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ComplianceOnline
- Start:
- Tuesday - Jul 30, 2013 10:00 AM
- End Time:
- Tuesday - Jul 30, 2013 11:10 AM
- Location:
- Online
- 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 engineering principles.
Why Should You Attend:
FDA is seeking to reduce “alarm fatigue" in hospitals by intensifying its pre-market review. The high number of false positive alarms and threats to patient safety due to missing or suppressed alarms are being reported. What can you do?
There have been several Class I medical device recalls related to alarms in patient monitoring devices, ventilators, infusion pumps, feeding pumps, cardiac monitors, sequential compression devices, dialysis machines, nurse call systems, hospital beds, medication dispensing systems, and chairs with exit alarms. The problem is failure to see the user behaviors and user needs for protection from harm. This topic is one of the top risk management issues for medical devices at FDA and at the Joint Commission, an accreditation body for the hospitals.
This webinar will help you 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 ergonomics and human engineering principles.
Learning Objectives:
By attending this session, you will learn
- How to design alarms that are intuitive and user friendly
- How to prevent alarm related harm to patients
- How to get FDA approval quickly
- Website:
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