Using the FDA MAUDE and Medical Device Recall Databases to Design Better Devices

Abstract

This article provides recommendations to manufacturers on using the Food and Drug Administration's MAUDE (Manufacturer and User Facility Device Experience) and Medical Device Recall databases to identify unknown use issues, discover design opportunities, and improve one's risk management file. These recommendations are based on the experiences of researchers who have spent time analyzing and working with both database systems and have developed a methodology for each. Manufacturers can leverage the suggested practices described in this article to address regulatory requirements. As medical devices and human-system interactions become more complex, usability issues are a persistent challenge and are gaining more recognition for their impact. A 2016 Johns Hopkins study reported that medical errors are the third leading cause of death in the United States.1 Prioritizing human factors is imperative to decrease the occurrence of design flaws, eliminate or reduce use-related hazards, improve patient adherence, and ultimately ensure safe outcomes for end users of medical devices. Objectives This article seeks to guide manufacturers on using the Food and Drug Administration's (FDA's) Manufacturer and User Facility Device Experience (MAUDE) and Medical Device Recall (hereafter referred to as Recall) databases to gain knowledge about medical device usability issues and develop safer devices. To achieve this objective, the researchers describe the two databases, demonstrate how to extract data from each, suggest ways to classify the data by root cause and identified trends, and explain how the findings can be used to develop better devices.