ComplianceOnline, Online Event
2013-07-30
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
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
- Design validation
- Usability analysis
- Usability testing
- Retrospective validation
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Invited Speakers:
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Dev Raheja, is a respected and sought out expert on hospital and medical device safety and author of the books Safer Hospital Care and Assurance Technologies Principles and Practices. He draws on his 25 years of experience as a risk management and quality assurance consultant to provide medical device stakeholders with a systematic way to learn the science of safety by design. He uses evidence-based safety theories and tools taken from the aerospace, nuclear, medical, and chemical industries to identify the combination of root causes that result in an adverse event. His focus is on using various types of innovation including accidental, incremental, strategic, and radical, and establish a culture conducive to high return on investment.
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