From directive to practice: applying FMEA to 177Lu therapy according to Euratom 2013/59

Background Radiometabolic 177 Lu-based treatment is a process that involves different specialists. Due to its high complexity and to the potential serious risk of health damages for patients and healthcare professionals, a global analysis of the whole process would allow to identify the weak points and then to improve clinical standards. Radioprotection risk assessment also fulfils the requirement of the 2013/59/EURATOM directive. Aim To identify the main critical points in the process of 177 Lu therapies by using the failure mode and effects analysis (FMEA) method. The focus of the FMEA analysis is the risk to the patient. Materials and methods We divided the whole process of 177 Lu-based therapies into main steps and identified all possible failure modes. Each failure mode was scored for severity (S), occurrence (O) and detectability (D), range 1–10. Based on the Risk Priority Number (RPN = SxOxD), all failures were ranked. Both in-house labelled or already and ready-for-injection radiopharmaceuticals were considered, as well as both 177 Lu-PSMA and 177 Lu-DOTATATE/TOC therapies. Results The failure modes with the highest RPN scores identified were: incorrect infusion supervision based on count measurements, incorrect catheter connections (vial–injection pump–patient), incorrect end of infusion, and false-negative pregnancy test results. Additionally, for in-house labelled radiopharmaceuticals, the incorrect selection of calibration factors in the activimetre for vial activity measure was identified as a critical issue. Conclusions The FMEA analysis allowed the identification of the main failure mode in 177 Lu treatment procedures. Based on the obtained results, strategies could be implemented in clinical practice in order to further improve patient safety. The present results may help the new implementation of 177 Lu-based therapy in the perspective of increasing use of these therapies.