FDA Concerns on Alarm Standards and Safety - Webinar By ComplianceOnline (FDA GXP Compliance -)
Venue: Online Event
|Event Date/Time: May 16, 2012||End Date/Time: May 16, 2012|
FDA is seeking to reduce â€œalarm fatigue" in hospitals by intensifying its pre-market review. 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.
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 human engineering principles.