Human Factors MD is pleased to have contributed to a new book covering the application of human factors to medical device design. Tim, Christina, Eric and Liz authored chapters on Root Cause Analysis and Human Factors Validation Testing of Combination Products.
Our Root Cause Analysis chapter outlines a framework for understanding the causes of errors people make when using a medical device. We begin by exploring differing views of use error, including a discussion of differing taxonomies that have been proposed for characterizing the causes of use errors. We go on to describe the objective of Root Cause Analysis and review methods for conducting Root Cause Analysis we have found helpful in practice. We outline how these methods can be applied to understanding the causes of errors with medical devices. Finally, we offer some insight into common pitfalls in conducting Root Cause Analysis and provide examples of good and bad descriptions of root causes.
In our chapter on Human Factors Validation Testing of Combination Products, we discuss the ways in which human factors validation testing of a combination product may differ from that of a medical device. These differences arise in part because combination products include a drug or biologic. The inclusion of a drug introduces use-related risks that are not of concern typically with medical devices. The inclusion of a drug or biologic in a combination product also means that a different center at the Food and Drug Administration (FDA) may lead the review for approval of the product than the center that leads reviews of medical devices. These centers have nuanced differences in their approach to human factors that have implications for human factors validation testing. We review these differences in this chapter. We also cover other human factors tests that may be needed instead of human factors validation tests to support marketing applications for combination products involving generic drugs or biosimilars, specifically Threshold Analysis and Comparative Use Human Factors Testing.
The book is edited by Mary Beth Privitera, published by Elsevier, and available for purchase on Amazon.