Mining MAUDE: Human Factors Perspectives on EHR and Device Design from the FDA Manufacturers and Users Device Experience Database

Electronic Health Record (EHR) systems have been under development for several years, and have been in operational use by individual practices and healthcare delivery institutions since at least 2008. The federal Food and Drug Administration (FDA) maintains the Manufacturer and User Facility Device Experience (MAUDE) database to collect voluntary and mandatory reports of adverse events involving medical devices. In recent years, this system has also been used for reporting incidents involving electronic health record (EHR) systems. An examination of the FDA's MAUDE database identified recent entries that point clearly to serious human factors issues in the design of EHR systems. This paper describes an initial attempt to develop a systematic approach to the analysis of MAUDE data with the specific goal to gain insight into the nature and number of human factors issues that may be implicated in adverse events involving EHR systems. The paper presents results of preliminary analysis using these techniques. The results suggest that human factors issues are beginning to emerge in the design of EHR systems, manifesting themselves as adverse health care outcomes.