Tracking Use Error Risks in Post-Market Surveillance and CAPA Activities

This webinar will apply to manufacturers with devices that require user-device interactions to set-up, operate, and maintain the device, and manage post market safety risks regarding use-related hazards. The FDA reports that over half of reported adverse events can be classified as design related. That estimate includes many instances of use related incidents linked to poor design of the user interface causing confusion, misuse, and inadvertent actions leading to patient or caregiver injuries or deaths. Ignoring problems related to user error is not an acceptable response to the FDA and is considered nonconformity. Participants in this webinar will learn about techniques that will be useful in analysis of post market human factors design problems and in preventing these problems through pro-active use of post-market surveillance techniques and customer support data.

Areas Covered in the seminar:

• What the FDA expects if a use error causes an adverse event.
• Building in use error analysis in post-market assessment of device risks.
• Techniques for quickly classifying use errors into design-related causes.
• How post-market use error data can be fed back to the design team efficiently.
• Questions your customer service department should be asking to identify use related hazards.

Who will benefit:

This webinar will apply to manufacturers with devices that require user-device interactions to set-up, operate, and maintain the device as well as track post market risks. Focus is on Job functions that will benefit include:

• Research and Development functions: risk management, hazard analysis, FMEA teams
• Regulatory and Compliance: those involved in responding to CAPA events
• Risk Management teams
• Customer Service Departments and Post Market Surveillance teams
• Consultants
• Operations and Manufacturing

Instructor Profile:
Robert A. North, PhD, is Chief Scientist of Human Centered Strategies, LLC specializing in creating strategies for applying Human Factors methods to medical device risk management and overall device effectiveness for several major manufacturers. Bob has worked as consultant to FDA/CDRH on analysis methods for use errors in adverse events, and is a member of the AAMI Human Factors Standards Committee currently developing a new standard for best practices. He has also recently served as faculty for Advamed (MTLI) in recent Design Controls seminars representing the FDA position on human factors. He is author or co-author on several articles appearing in MDDI’s Device Link (on-line) and is on the faculty of the Regulatory Affairs Professional Society’s (RAPS) 2008 Horizons Conference, presenting seminars on use error risk management strategies.

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