Applying failure mode effects and criticality analysis in radiotherapy: Lessons learned and perspectives of enhancement

Introduction: The radiation oncology process along with its unique therapeutic properties is also potentially
dangerous for the patient, and thus it should be delivered under a systematic risk control. To this
aim incident reporting and analysis are not sufficient for assuring patient safety and proactive risk assessment
should also be implemented. The paper accounts for some methodological solutions, lessons
learned and opportunities for improvement, starting from the systematic application of the failure mode
effects and criticality analysis (FMECA) technique to the radiotherapy process of an Italian hospital.
Materials and methods: The analysis, performed by a working group made of experts of the radiotherapy
unit, was organised into the following steps: (1) complete and detailed analysis of the process (integration
definition for function modelling); (2) identification of possible failure modes (FM) of the process,
representing sources of adverse events for the patient; (3) qualitative risk assessment of FMs, aimed at
identifying priorities of intervention; (4) identification and planning of corrective actions.
Results: Organisational and procedural corrective measures were implemented; a set of safety indexes for
the process was integrated within the traditional quality assurance indicators measured by the unit. A
strong commitment of all the professionals involved was observed and the study revealed to be a powerful
‘‘tool” for dissemination of patient safety culture.
Conclusion: The feasibility of FMECA in fostering radiotherapy safety was proven; nevertheless, some lessons
learned as well as weaknesses of current practices in risk management open to future research for
the integration of retrospective methods (e.g. incident reporting or root cause analysis) and risk
assessment.