Addressing the Elusive Use Error: Meeting Regulatory Expectations for Identifying and Controlling Medical Device Use-Related Hazards

The FDA's Center for Devices and Radiological Health (CDRH) has recently reported that over a third of adverse events can be traced to use errors -- incorrect or omitted actions by users when interacting with a device. Although often seen as a consequence of the unpredictable and inevitable results of "human error", such errors are often attributable to poor design of the user interface and lack of application of best design practices and human factors methods. Consequences are serious for the manufacturer including recalls and product seizures. In this webinar, we will review basic FDA expectations for evidence of adequate analysis and testing to identify the severity and likelihood of use errors, and validation of risk mitigations through usability testing with representative users. A brief method overview, as applied to the overall Design Controls process phases, will be presented. One or two case studies will be included representing recent consequences of lack of attention to use error control and prevention.

Areas Covered in the seminar:

• How the FDA defines Use Error and why it is viewed as essential in the overall risk management strategy.
• Consequences of lack of attention to use errors including recalls and seizures.
• Introduction to Human Factors methods as use error risk management tools and their application in Design Controls.
• Understanding use error -- a quick analysis method.
• Differences between conventional FMEA and Hazard Analysis and Use Error identification techniques.
• Quick review and identification of currently accepted standards and guidance’s for Human Factors best practice.
• Blending Human Factors with existing device design and validation methods.

Who will benefit:

This webinar will apply to manufacturers with devices that require user-device interactions to set-up, operate, and maintain the device. Focus is on an overall risk management strategy for use error prevention and improved effectiveness of use. Job functions that will benefit include:

• Research and Development functions: software, mechanical, industrial design, systems engineering
• Regulatory and Compliance: understanding the liabilities and consequences of unmanaged use error risks and interacting with CDRH
• Marketing & Market Research
• Customer Service and Customer Support
• Quality System Management teams

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.

Follow us :