Advancing risk management in nuclear medicine diagnostic and therapy through incident-driven risk management tools - Advances risk management in nuclear medicine

Sep 29, 2026

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Accidental or unintended exposures in nuclear medicine create substantial patient risks, requiring proactive, structured risk management. The study develops and implements a software tool that combines Failure Modes and Effects Analysis (FMEA) and Fault Tree Analysis (FTA) into a unified platform for diagnostic and therapeutic workflows. Multicenter results show improved standardization of risk analysis, stronger interdisciplinary collaboration, and scenario ranking using a refined Risk Priority Number (RPN). The approach supports scalable patient safety practices and future template refinement.

LanguageEnglish

CategoryResearch & Report

FormatPDF

Pages7

Reading Time18 min

AccessFree to download

Abstract

Introduction

Regulatory requirements for medical exposure risk management

Definition and types of unintended exposures in nuclear medicine

Failure Modes and Effects Analysis (FMEA) and Risk Priority Number (RPN)

| Original Paper
Advancing risk management in nuclear medicine diagnostic and therapy through incident-driven risk management tools ✩
Lidia Strigari a,⁎, David Menichellib, Elisa Lodi Rizzini c, Arber Golemid, Gian Mauro Sacchetti e, Lucia Leva e, Cristina Nannid, Paolo Castelucci d, Stefano Fantid,f, Alessio Giuseppe Morganti c,f, Roberta Matheoud g
a Department of Medical Physics, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy bIBA Dosimetry, Bahnhofstraße 5, 90592 Schwarzenbruck, Germany
c Radiation Oncology, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy d Nuclear Medicine, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy e Nuclear Medicine Department, University Hospital Maggiore della Carità, Novara, Italy
fDepartment of Medical and Surgical Sciences (DIMEC), Alma Mater Studiorum University of Bologna, Bologna, Italy g Medical Physics Department, University Hospital Maggiore della Carità, Novara, Italy | | | | --- | --- | --- | | A R T I C L E I N F O | | A B S T R A C T | | Keywords:
Radiation safety Patient risk analysis Nuclear medicine Radioembolization Radioligand therapy Extravasation | | Accidental or unintended exposures in nuclear medicine present signiﬁcant risks, demanding proactive and systematic risk management strategies. This study explores the development and implementation of a novel software tool that integrates Failure Modes and Effects Analysis (FMEA) and Fault Tree Analysis (FTA) into auniﬁed platform tailored for nuclear medicine. The tool addresses the complexities of risk assessment across diagnostic and therapeutic workﬂows, offering customizable templates and a streamlined process for identifying, prioritizing, and mitigating failure modes.
A multicenter study involving nuclear medicine departments of various sizes demonstrated the tool’s efﬁcacyin standardizing risk analysis and enhancing interdisciplinary collaboration. Key scenarios, such as errors in radiopharmaceutical preparation and administration, were assessed, with rankings assigned based on a reﬁned Risk Priority Number (RPN) system.
The results underscore the transformative potential of combining FMEA and FTA in nuclear medicine, addressing the limitations of standalone methodologies. This approach improves workﬂow efﬁciency and ensures a robust framework for patient safety. Future directions include expanding the tool’s applications, reﬁning templates, and fostering a proactive culture of risk assessment. These advancements pave the way for safer, more efﬁcient practices in nuclear medicine, beneﬁting patients and professionals alike. | Introduction European Council Directive 2013/59/EURATOM [1] requires that Member States ensure that (a) all reasonable measures are taken to minimize the probability and magnitude of accidental or unintended exposures of individuals subject to medical exposure, and (b) for radiotherapeutic practices the quality assurance program includes a study of the risk of accidental or unintended exposures. Unintended exposures in the context of medical procedures are taken as meaning the exposure of a patient to a different radiation level than it was planned for the procedure carried out [2]. If the patient risk analysis in radiotherapy practice has been thoroughly explored and several reports, papers and guidelines have been published by international commissions and organizations [3–7], the risk analysis for nuclear medicine procedures has been studied only recently [2,8,9]. As far as nuclear medicine is concerned, unintended exposures are related to misadministration of radiopharmaceutical activities to patients for both diagnostic and therapeutic procedures. In this context, misadministration refers to the inadvertent administration of the radiopharmaceutical to an incorrect patient, the administration of an inappropriate radiopharmaceutical or an incorrect activity to ✩ This article is part of a special issue

FAQs

What problem does the study address in nuclear medicine risk management?

The study addresses accidental or unintended exposures during nuclear medicine diagnostic and therapeutic procedures, which require proactive risk management strategies.

What is the core method proposed by the authors?

The authors propose a software tool integrating Failure Modes and Effects Analysis (FMEA) and Fault Tree Analysis (FTA) into a unified platform with customizable templates.

How was the tool evaluated and what outcomes were reported?

A multicenter study evaluated the tool across nuclear medicine departments of different sizes, showing its effectiveness in standardizing risk analysis and improving interdisciplinary collaboration, with scenario ranking via a refined RPN system.

Sep 29, 2026

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