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FDA Concerns on Alarm Standards and Safety
Wednesday, May 16, 2012 from 10:00 AM to 11:00 AM (PDT)
Palo Alto, CA
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. 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.
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
For Registration :
When & Where
At ComplianceOnline, we are focused on :
- Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.
- Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.
- Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.
- Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.