FDA Increases Focus on Human Factors in Medical Device Design

  

  

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Recognizing user error as one of the greatest factors contributing to patient and health care worker injury from medical devices, recent guidance from the FDA stresses the importance of human factors and usability engineering in the design and risk analysis of new medical devices.  

The guidance document details how to apply human factors and usability engineering in design of medical devices in order to optimize safety and effectiveness. Medical device design engineers are reminded to focus on thoroughly analyzing all users who will be handling the device, as well as the settings and conditions in which they will be working. All aspects of the design must be considered to create a device that facilitates correct actions and prevents or discourages incorrect actions by the user.  

In response to this document, Fallbrook Engineering is encouraged in our efforts to provide our clients with the most current and effective risk analysis and management services. We offer the expert services of our Risk Specialist, John Slate, PhD., for every project. Our President and CEO, Richard Meyst, is a guest lecturer on the benefits of Risk Management at both the University of California San Diego and San Diego State University, as well as at industry events. Mr. Meyst has presented for the Overview of FDA Regulations for Medical Device Professionals course and Current Good Manufacturing Practices: Advanced Topics course.  

The new guidance from FDA reminds all businesses in the medical device design industry that considering human factors and usability engineering is extremely important in the risk analysis and management of a project. Patient and user safety is a critical goal of all medical device design. A product that was designed to comply with the most effective risk analysis properties will likely have fewer recalls, updates and extensive modifications, and will have a competitive edge over other products in the marketplace.

For more information please see FDA’s Applying Human Factors and Usability Engineering to Optimize Medical Device Design