Designing Medical Device Alarms to Mitigate New FDA Concerns

Why Should You Attend:

Medical device reports indicate that it is usually difficult to assign a root cause to problems reported concerning device alarm systems. The most common alarm system issue is that the device does not provide a critical alarm capable of getting the attention of the care giver. Frequently, the alarms are not heard or they have been silenced or deactivated and never set. This often results in nurses not responding to patients in crisis. The FDA has received over 500 fatality reports from no response to alarms.

This webinar goes a step further. It will detail why the most appropriate strategy is to eliminate non-urgent alarms as much as possible. Hundreds of alarms can be eliminated by design or by integrating them into a patient’s condition monitoring.

Learning Objectives:

• Understand the hospital needs for effective alarms
• Understand the risks of device alarms
• Understand how to differentiate between urgent alarms and non-urgent alarms
• Learn how to validate alarm effectiveness
• Learn to assure effectiveness of alarms

Areas Covered in the Webinar:

• FDA concerns for alarm systems
• Type of alarm safety hazards
• How many alarms do large hospitals have?
• Different kinds of alarms hospitals have
• Obstacles in solving alarm risk issues
• Designing user interface based on sound human factors engineering
• Design strategies for system alarms that indicate the device requires attention rather than the patient
• General standardization strategies
• What is FDA doing to mitigate the risks?
• Current improvements done by hospitals

Who Will Benefit:

• Senior managers
• Design engineers
• R&D engineers
• Quality assurance supervisors
• Production supervisors
• Quality professionals
• Regulatory professionals
• Compliance professionals
• Manufacturing engineers
• Production engineers
• Quality auditors
• Document control specialists

Instructor Profile:

Dev Raheja, MS,CSP, author of the books Preventing Medical Device Recalls and Safer Hospital Care, is an international risk management, patient safety and quality assurance consultant for medical device, healthcare and aerospace industry for over 25 years. Prior to becoming a consultant in 1982, he worked at GE Healthcare as supervisor of quality assurance/manager of manufacturing engineering, at Cooper Industries as chief engineer, and at Booz-Allen & Hamilton as risk management consultant for a variety of industries.

His clients include Johnson & Johnson, Siemens Medical Systems, Medtronic, Carl Zeiss, Warner-Lambert, Zimmer Holdings, and DuPont. He has served as adjunct professor at the University of Maryland for five years for its PhD program in reliability engineering. He is a Fellow of American Society for Quality and recipient of its Austin Bonis Award for Reliability Education Advancement, former chair of the Reliability Division, and member of the Biomedical Division. He is a senior member of IEEE. Currently, Mr. Raheja serves as an adjunct professor at the Florida Tech for its BBA degree in healthcare management, and has authored two more books - Assurance Technologies Principles and Practices; and Zen and the Art of Breakthrough Quality Management. He has received several industry awards including the Scientific Achievement Award and Educator-of-the Year Award from the System Safety Society. He is a former National Malcolm Baldrige Quality Award Examiner in the first batch of examiners. He serves on the Patient and Families Advisory Council at Johns Hopkins Hospital and is a member of American College of Healthcare Executives.

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