TY - JOUR
T1 - Enhancing safety
T2 - Multi-institutional FMEA and FTA on 177Lu-based radio-pharmaceutical therapy
AU - George, Siju C.
AU - Aguirre, Santiago
AU - Maughan, Nichole M.
AU - Tolakanahalli, Ranjini
AU - Samuel, E. James Jebaseelan
AU - Gallo, Sven L.
AU - Zoberi, Jacqueline E.
AU - Lee, Yongsook C.
N1 - Publisher Copyright:
© 2024 The Author(s). Journal of Applied Clinical Medical Physics published by Wiley Periodicals LLC on behalf of American Association of Physicists in Medicine.
PY - 2025/1
Y1 - 2025/1
N2 - Purpose: This study investigates potential failure modes and conducts failure mode and effects analysis (FMEA) and fault tree analysis (FTA) on the administration of (Formula presented.) DOTATATE (LUTATHERA) and (Formula presented.) PSMA-617 (PLUVICTO). The quality management (QM) process in radiopharmaceutical therapies (RPTs) requires collaboration between nuclear medicine (NM) and radiation oncology (RO) departments. As part of a multi-institutional study, we surveyed various departments to identify and analyze failure modes, leading to a proposed comprehensive QM program. RPT teams in RO or NM clinics can benefit from this study by continually improving their practice. Methods: We reviewed the literature to investigate the administration of Pluvicto and Lutathera, focusing on prospective procedural failures and potential failure modes (PFMs) and their outcomes. We distributed an FMEA survey to multiple experienced centers in (Formula presented.) -based RPTs and calculated risk priority number (RPN) for various PFM. We conducted an FTA using this information to pinpoint the root causes of potential failures. Results: The findings from the literature review and survey responses on the prospective study have identified several critical areas at risk of failure. These areas include non-optimized treatment delivery, inadequate patient monitoring, and lack of safety training, leading to radiation contamination from the dose excreted by the patients after treatment administration. A segmented FTA was created based on the FMEA results, focusing on radiation contamination with a high RPN value. Conclusion: By identifying the root causes of failures and proposing targeted improvements to the existing QM measures, this analysis enhances safety in treatment delivery of (Formula presented.) -based RPTs. Given the limited number of prospective risk analysis studies in RPTs, our research addresses the necessity for more such studies and recommends methods to apply this study to other RPTs.
AB - Purpose: This study investigates potential failure modes and conducts failure mode and effects analysis (FMEA) and fault tree analysis (FTA) on the administration of (Formula presented.) DOTATATE (LUTATHERA) and (Formula presented.) PSMA-617 (PLUVICTO). The quality management (QM) process in radiopharmaceutical therapies (RPTs) requires collaboration between nuclear medicine (NM) and radiation oncology (RO) departments. As part of a multi-institutional study, we surveyed various departments to identify and analyze failure modes, leading to a proposed comprehensive QM program. RPT teams in RO or NM clinics can benefit from this study by continually improving their practice. Methods: We reviewed the literature to investigate the administration of Pluvicto and Lutathera, focusing on prospective procedural failures and potential failure modes (PFMs) and their outcomes. We distributed an FMEA survey to multiple experienced centers in (Formula presented.) -based RPTs and calculated risk priority number (RPN) for various PFM. We conducted an FTA using this information to pinpoint the root causes of potential failures. Results: The findings from the literature review and survey responses on the prospective study have identified several critical areas at risk of failure. These areas include non-optimized treatment delivery, inadequate patient monitoring, and lack of safety training, leading to radiation contamination from the dose excreted by the patients after treatment administration. A segmented FTA was created based on the FMEA results, focusing on radiation contamination with a high RPN value. Conclusion: By identifying the root causes of failures and proposing targeted improvements to the existing QM measures, this analysis enhances safety in treatment delivery of (Formula presented.) -based RPTs. Given the limited number of prospective risk analysis studies in RPTs, our research addresses the necessity for more such studies and recommends methods to apply this study to other RPTs.
KW - 177Lu$^{177}{\rm Lu}$ radiopharmaceutical therapy
KW - failure mode effects analysis
KW - fault tree analysis
KW - process map
KW - prospective analysis
KW - quality management
UR - http://www.scopus.com/inward/record.url?scp=85209114312&partnerID=8YFLogxK
U2 - 10.1002/acm2.14550
DO - 10.1002/acm2.14550
M3 - Article
C2 - 39535854
AN - SCOPUS:85209114312
SN - 1526-9914
VL - 26
JO - Journal of applied clinical medical physics
JF - Journal of applied clinical medical physics
IS - 1
M1 - e14550
ER -