Proactive risk analysis in chemotherapy nursing processes: A systematic review of FMEA/FMECA applications.

Abstract

BackgroundChemotherapy management is a high-risk process, especially in oncology nursing, where errors can have serious consequences. Proactive risk analysis tools such as Failure Mode and Effects Analysis (FMEA) and its variant with Criticality Analysis (FMECA) are increasingly used to enhance safety.AimTo systematically review the effectiveness of FMEA/FMECA methodologies in identifying and mitigating risks within nursing processes related to chemotherapy preparation, administration, and management.MethodsA systematic review was conducted following PRISMA 2020 guidelines. Literature was searched in PubMed and the Cochrane Library (as of February 9, 2025), including studies published from 2016 onwards in English, Italian, or Spanish. The quality of included studies was assessed using the Newcastle-Ottawa Scale, and a qualitative synthesis was performed.ResultsThirteen studies met the inclusion criteria. FMEA/FMECA proved effective in identifying vulnerabilities in chemotherapy workflows, leading to the implementation of preventive and corrective actions. Improvements were observed in patient and staff safety, error reduction, process standardization, and integration of technological solutions.ConclusionFMEA/FMECA are valuable tools in proactively managing risks in oncology nursing. Their success depends on the active involvement of nursing staff and continuous training. Routine use is recommended to improve care quality and occupational safety.