Healthcare Application of Failure Mode and Effect Analysis (FMEA): Is There Room in the Infectious Disease Setting? A Scoping Review

Background: Failure mode and effect analysis (FMEA) is a valuable risk analysis tool aimed at predicting the potential failures of a system and preventing them from occurring. Since its initial use, it has also recently been applied to the healthcare setting, which has been made progressively more complex by technological developments and new challenges. Infection prevention and control (IPC) is an area that requires effective strategies. The aim of this study is to review the literature on the employment of FMEA in the healthcare environment, with special consideration for its application in the infectious disease setting. Methods: An extensive search was carried out in two international and public databases, PUBMED and EMBASE; we included all studies regarding the use of FMEA in hospital settings and human patient care processes. Results: A total of 163 studies published over the period from 2003 to 2023 were included for data extraction. These studies were analyzed regarding bibliometric data (publication year and country of origin), the healthcare issues to be addressed, the application fields, and the utilized FMEA methods. Among these, 13 studies were found that took an interest in infectious diseases. Conclusions: FMEA can be effectively used for healthcare risk assessment. Its implementation as a standard tool in healthcare settings, though demanding, may serve as an important tool for preventing the risk of biohazard incidents, epidemics, and environmental contamination, thereby improving safety for both patients and healthcare workers.