https://doi.org/10.1140/epjp/s13360-026-07582-z
Regular Article
From directive to practice: applying FMEA to 177Lu therapy according to Euratom 2013/59
1
Medical Physics Department, IRCCS Istituto Romagnolo Studio Tumori “Dino Amadori”, Meldola (FC), Italy
2
Medical Oncology Ward Department, IRCCS Istituto Romagnolo Studio Tumori “Dino Amadori”, Meldola (FC), Italy
3
Nuclear Medicine Department, IRCCS Istituto Romagnolo Studio Tumori “Dino Amadori”, Meldola (FC), Italy
4
Oncology Pharmacy Department, IRCCS Istituto Romagnolo Studio Tumori “Dino Amadori”, Meldola (FC), Italy
5
Nursing and Technical Directory Department, IRCCS Istituto Romagnolo Studio Tumori “Dino Amadori”, Meldola (FC), Italy
6
Healthcare Direction Department, IRCCS Istituto Romagnolo Studio Tumori “Dino Amadori”, Meldola (FC), Italy
a
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Received:
16
June
2025
Accepted:
18
March
2026
Published online:
16
April
2026
Abstract
Background: Radiometabolic 177Lu-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 177Lu 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 177Lu-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 177Lu-PSMA and 177Lu-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 177Lu 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 177Lu-based therapy in the perspective of increasing use of these therapies.
Supplementary Information The online version contains supplementary material available at https://doi.org/10.1140/epjp/s13360-026-07582-z.
© The Author(s) 2026
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