Author: Jeremy T. Booth, Sonja Dieterich, Jonathan Hindmarsh, Paul J. Keall 👨🔬
Affiliation: Northern Sydney Cancer Centre, Royal North Shore Hospital, UC Davis Medical Center, Image X Institute, Faculty of Medicine and Health, The University of Sydney 🌍
Purpose: Prospective hazard analysis (PHA) is a core medical physics function. PHA was investigated by AAPM Task Group 100 for the purpose of keeping patients safe and assessing the risks of novel technologies. This work reviews the PHA literature focusing on which technologies have been assessed and what can be learnt.
Methods: The search for English language, peer-reviewed, full-text articles was conducted across five databases and the citations of three seminal papers using a common search strategy. The collation, filtration, and analysis of articles was conducted in accordance with the PRISMA-statement reporting standard utilising a PICOS approach.
Results: 61 studies were determined to be eligible for inclusion. PHA has been applied to C-arm treatment systems (19), SRS (8), TomoTherapy (6), SBRT (5), Ethos (5), Halcyon (3), MRIdian (3), review activities (3), commissioning (2), Unity (1), CyberKnife (1), RefleXion (1) and other novel software and hardware systems (6). Disciplines involved in the studies were physicists (92%), physicians (75%), radiation therapists or dosimetrists (71%), external experts (38%), and facilitators (33%). Failure mode and effects analysis (FMEA) was used in 79% of studies, 10% used FMEA derived methods, 10% used system theoretic process analysis. High-risk failure modes (579) were extracted from studies, 50% applied to patient treatment delivery sessions and 25% applied to contouring and treatment planning. The mitigation strategies recommended by studies tended to add to the departmental workload.
Conclusion: 61 studies were identified that used PHA in radiotherapy. PHA was found to identify previously unknown failure modes that impacted patient safety. However, it was not apparent that any meaningful reductions in workload were achieved. Due to the variability in how studies were published, learnings for conducting future PHAs were limited. The findings of this review should be used to inform recommendations around how to better perform and publish PHA studies.