Root cause analysis

Abstract To make medical devices safer and to optimize their designs, manufacturers need to understand when users are likely to have difficulties using devices and the factors that contribute to or cause errors. This isn't just good practice. Regulators require that manufacturers conduct root cause analysis of use issues that arise during validation testing in order to determine the residual risk and priorities for implementing additional risk management measures (Food and Drug Administration, 2016). This chapter outlines a framework for understanding the causes of errors people make when using a medical device. It begins by exploring differing views of error, including a discussion of differing taxonomies that have been proposed for characterizing the causes of use errors. It describes the objective of Root Cause Analysis and reviews methods for conducting that are found helpful in practice. It describes how these methods can be applied to understanding the causes of errors with medical devices. Finally, this chapter discusses pitfalls in conducting Root Cause Analysis with examples of good and bad descriptions of root causes.