Aditya Pratama Putra
Radiopharmaceutical handling is a complex process involving both pharmaceutical risks and radiation exposure throughout the healthcare workflow. Therefore, an effective risk management approach is required to systematically identify potential failures before they compromise patient and staff safety. This study reviews the application of Failure Mode and Effects Analysis (FMEA) in radiopharmaceutical risk management through a narrative literature review. Scopus-indexed articles published between 2016 and 2026 were analyzed, with the final literature search conducted in June 2026. The review included studies on radiopharmacy, nuclear medicine, radiotherapy, and healthcare quality management. The findings indicate that FMEA effectively identifies and prioritizes failure modes using the Risk Priority Number (RPN). Major risks include patient misidentification, radiolabeling errors, dose calculation errors, and human and communication factors. The reviewed studies demonstrate that FMEA improves patient safety, strengthens quality management systems, and promotes a safety culture through integration with Fault Tree Analysis (FTA) and incident learning systems. However, further standardization of risk assessment methods and prospective multi-institutional studies are needed to strengthen FMEA implementation in radiopharmaceutical therapy. FMEA is recommended as an integral component of quality management and radiation safety systems to improve the quality of radiopharmaceutical services. Keywords: Failure Mode and Effects Analysis (FMEA), risk management, radiopharmaceuticals, radiation safety, nuclear medicine