AbstractRationale, aims, and objectivesFailure mode and effects analysis (FMEA) is a valuable reliability management tool that can preemptively identify the potential failures of a system and assess their causes and effects, thereby preventing them from occurring. The use of FMEA in the healthcare setting has become increasingly popular over the last decade, being applied to a multitude of different areas. The objective of this study is to review comprehensively the literature regarding the application of FMEA for healthcare risk analysis.MethodsAn extensive search was carried out in the scholarly databases of Scopus and PubMed, and we only chose the academic articles which used the FMEA technique to solve healthcare risk analysis problems. Furthermore, a bibliometric analysis was performed based on the number of citations, publication year, appeared journals, authors, and country of origin.ResultsA total of 158 journal papers published over the period of 1998 to 2018 were extracted and reviewed. These publications were classified into four categories (ie, healthcare process, hospital management, hospital informatization, and medical equipment and production) according to the healthcare issues to be solved, and analyzed regarding the application fields and the utilized FMEA methods.ConclusionFMEA has high practicality for healthcare quality improvement and error reduction and has been prevalently employed to improve healthcare processes in hospitals. This research supports academics and practitioners in effectively adopting the FMEA tool to proactively reduce healthcare risks and increase patient safety, and provides an insight into its state‐of‐the‐art.