Understanding Use Errors for Medical Devices: Analysis of the MAUDE Database

Abstract

Use error is a type of error in a system wherein a user’s actions—or lack of actions— result in a different outcome than intended, possibly resulting in an adverse event. Use error in medicine is especially important, as adverse events can result in life-critical situations. Studies investigating use error have been conducted using databases of medical adverse events (e.g., the United States Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database of adverse events related to device usage). However, these studies are limited by being specific to a context of use (e.g., drug delivery pumps in anesthesia). Therefore, this study investigated use error for medical devices across all contexts of use through a systematic search of the MAUDE database. We found that use error 1) is reported across many sub-fields and contexts of medicine; 2) is associated with many steps in the device usage process; 3) occurs during device operation by both lay users and health professionals; 4) has varying underlying causes; 5) cooccurs in adverse events; and 6) results in a wide array of outcomes, including death. This analysis provides valuable insights into characteristics and context of use errors that can guide design to minimize such errors.