Abstract

Background: Approximately 10% of hospitalized patients experience adverse events, many of which are preventable. Failure Mode and Effects Analysis (FMEA) is a proactive risk management tool used to identify potential failures before they occur. Objectives: This study aimed to synthesize existing evidence on the application of Failure Mode and Effects Analysis (FMEA) in hospital settings and to describe the reported outcomes of FMEA implementation in quality improvement and patient safety across selected clinical domains. Methods: A systematic review following PRISMA 2020 guidelines was conducted using PubMed, Scopus, and Web of Science databases for studies published between 2000 and 2025. Data were extracted and synthesized using a narrative approach. Results: A total of 35 studies were included in the review. FMEA was mainly applied in high-risk hospital processes such as medication management, laboratory testing, blood transfusion, surgery, and radiotherapy. The included studies commonly reported changes in Risk Priority Number (RPN), reductions in process-related errors, improved compliance, and enhanced patient safety following FMEA implementation. Frequently reported implementation components included process standardization, checklist use, and the application of information technology to support risk assessment. 210 TẠP CHÍ Y DƯỢC HUẾ - HUE JOURNAL OF MEDICINE AND PHARMACY ISSN 3030-4318; eISSN: 3030-4326 Conclusions: The reviewed studies suggest that FMEA has the potential to support risk identification and process improvement in hospital settings, particularly in high-risk and multi-step processes. However, further studies with more rigorous designs are needed to better evaluate the effectiveness and applicability of FMEA across different healthcare contexts.