Failure mode and effects analysis of hazardous drugs preparation workflows using isolators with contextual evaluation of laminar airflow cabinets in hospital pharmacy

BackgroundHazardous drugs preparation is a high-risk process requiring strict control of aseptic conditions to ensure product sterility and to protect healthcare workers. Isolators and laminar airflow cabinets are widely used in hospital pharmacies for the preparation of hazardous drugs. Structured assessments of process-related risks associated with routine handling practices remain limited.ObjectivesThis study aimed to apply Failure Mode and Effects Analysis (FMEA) to identify and prioritize high-risk handling steps in hazardous drugs preparation workflows using isolators and to evaluate risk profiles associated with laminar airflow cabinets.MethodsAn observational FMEA-based risk assessment was conducted in a hospital pharmacy during routine hazardous drugs preparation. Six critical handling steps were evaluated: glove installation, surface cleaning, material transfer, documentation, waste removal, and glove removal. For isolator-based preparation, 100 routine preparations were directly observed to quantify failure frequencies and to assign occurrence scores. For laminar airflow cabinets, failure modes and occurrence levels were evaluated using observational insights combined with structured expert consensus. Severity and detection scores were assigned by an interdisciplinary expert panel. Risk Priority Numbers (RPNs) were calculated to prioritize critical failure modes.ResultsFMEA identified surface cleaning, material transfer, and glove handling as the most critical steps in hazardous drugs preparation workflows. In isolator-based preparation, the highest initial RPNs were observed for surface cleaning (RPN = 240), material transfer (RPN = 210), and glove installation (RPN = 144). Risk assessment highlighted different underlying drivers of failure across workflows. In isolators, elevated risks were mainly associated with handling complexity and limited detectability of failures within a closed system. In laminar airflow cabinets, risks were primarily related to open-system exposure and greater dependance on operator technique and environmental control.ConclusionFMEA proved to be a practical tool for systematically identifying and prioritizing risks in hazardous drugs preparation workflows. The analysis highlighted critical handling steps requiring targeted risk mitigation strategies and demonstrated the importance of workflow design, operator training, and adherence to standard operating procedures. The proposed FMEA-based approach provides a transferable framework to support continuous quality improvement and enhance safety in oncology pharmacy practice.