FDA Concerns on Alarm Standards and Safety - Webinar by ComplianceOnline

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. 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.

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.

Who Will Benefit:

This webinar will provide valuable assistance to all personnel in:

• R&D engineers and managers
• Regulatory Compliance Associates and Managers
• Anyone involved in risk analysis
• Quality Assurance personnel
• Marketing and Servicing staff