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Failure modes and effects analysis for clinical implementation of online adaptive radiotherapy: A systematic review.

Deepikaa Balaji·Sonja Wegener·Sebastian Klüter·Sara L Hackett
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Abstract

BACKGROUND: The accuracy of radiotherapy is limited by anatomical variations occurring over time scales ranging from sub-seconds to days. Online Adaptive Radiotherapy (OART) addresses this by enabling daily plan adaptation based on real-time imaging. While OART offers improved dose conformity, its dynamic, time-constrained workflow introduces novel failure modes that challenge traditional quality assurance protocols. PURPOSE: This study aims to synthesize the existing literature on Failure Modes and Effects Analysis (FMEA) for OART to systematically catalog risks and identify mitigation strategies. METHODS: A systematic literature search was conducted to identify studies applying FMEA to OART workflows. Eleven studies were included, covering MR-guided (ViewRay MRIdian, Elekta Unity), CBCT-guided (Varian Ethos), and MR-enhanced C-arm linac systems. To address heterogeneity in risk scoring methodologies (e.g., TG-100 10-point scales vs. 5-point rankings), extracted failure modes were harmonized into a standardized three-tier risk classification system (Class I: Low, Class II: Intermediate, Class III: High). RESULTS: A total of 300 unique failure modes were identified, with 49.6 percent classified as high-risk (Class III). Analysis revealed that the majority of high-risk failures were concentrated in the online treatment delivery phase, specifically within human-computer interactions and anatomical contouring steps. CONCLUSIONS: This study supports the development of tailored, robust QA frameworks that prioritize human factors and process consistency to guide safe implementation in diverse clinical settings.

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HumansRadiotherapy Planning, Computer-AssistedQuality Assurance, Health CareRadiotherapy DosageNeoplasmsRadiotherapy, Intensity-ModulatedHealthcare Failure Mode and Effect AnalysisOrgans at RiskRadiotherapy, Image-GuidedParticle AcceleratorsFailure Modes and Effects AnalysisOnline Adaptive RadiotherapyQuality AssuranceJournal ArticleSystematic ReviewReview

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Deepikaa Balaji, Sonja Wegener, Sebastian Klüter, Sara L Hackett. 2026. Failure modes and effects analysis for clinical implementation of online adaptive radiotherapy: A systematic review.. https://doi.org/10.1002/acm2.70749

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Humans subjectJournal Article subjectJournal Article; Systematic Review; Review resourceNeoplasms subjectSystematic reviews study

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