
==== Front
Z Med Phys
Z Med Phys
Zeitschrift für Medizinische Physik
0939-3889
1876-4436
Elsevier

S0939-3889(24)00050-3
10.1016/j.zemedi.2024.05.002
Forum
Risk management in radiation-based therapies
Bert Christoph christoph.bert@uk-erlangen.de

Department of Radiation Oncology, University Hospital Erlangen, Friedrich-Alexander-University Erlangen-Nürnberg (FAU), Erlangen, Germany
12 6 2024
8 2024
12 6 2024
34 3 355356
© 2024 The Author
2024
https://creativecommons.org/licenses/by-nc-nd/4.0/ This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
==== Body
pmcQuality management in radiation therapy rests on several pillars, including quality assurance and risk management, as outlined in details in the Radiation Protection Series Publication RP 181 of the European Commission [1]. With Council Directive 2013/59/EURATOM, risk management was introduced for radiation therapy and was transposed into national law in Germany by the Radiation Protection Ordinance (StrSchV) in 2019. In addition to the regulations on radiation protection, IT security, general quality management, e.g. in accordance with ISO 9001, regulations on patient treatment in general, or the Medical Device Regulation also require risk management [2]. Each of these sectors has a different flavor, but often involves the same staff, especially medical physicists, who, at least in Germany, are also formally obliged to support risk analysis for radiation based-therapies according to §132 StrSchV.

Although risk management has been formally required in Germany for more than 5 years, the transition to daily practice in clinical institutions, but often also in regulatory bodies, is still ongoing and a steady state has not yet been reached. This is natural and in line with experiences reported from France, for example, where risk management was introduced in 2009 and it took a decade to implement the tools [3]. The German Society for Medical Physics (DGMP) was involved early on in supporting the implementation of risk analysis in Germany. In 2015, the Federal Office for Radiation Protection (BfS) and several German associations presented a report [4], and in 2017 a DGMP working group on risk management was founded, which recently published two reports on the implementation of risk management [5], [6]. This special issue of Zeitschrift für Medizinische Physik also aims to support the process of reaching a steady state in the implementation of risk management. It is one of the first virtual special issues of the journal, i.e., it will be complemented in the coming months and will then be available as an online collection of articles related to risk management.

As a starting point for this issue, Kornek et al. propose a process failure mode and effects analysis (PFMEA) template and an iteration of the action priority (AP) as an alternative to the commonly used risk priority number (RPN) [7]. The establishment of alternatives to the RPN has already been proposed in an editorial in this journal in 2021 [8]. The proposed AP is a radiation oncology-specific iteration of an implementation in the automotive industry and was benchmarked against the number of corrective actions to mitigate the effects of failure modes.

The second paper addresses a risk management tool for daily practice [9]. This contribution focuses on the clinical implementation and benchmarking of a new software that provides FMEA and fault tree analysis.

The other two papers by Wegener et al. deal with the risk assessment of a novel adaptive radiation therapy device based on cone beam computed tomography. In the first article, the authors describe a prospective risk analysis that identified 122 potential adverse events, leading to the implementation of additional quality assurance measures [10]. After one year of clinical experience, they recorded 126 irregularities, not all of which had been prospectively anticipated [11]. These findings support the formal requirement of §126 StrSchV for a regular update of the risk analysis.

The current collection of articles in this issue can be seen as an introduction and kick-off to this rather important topic. As mentioned above, all further incoming articles on this topic will not only be published in future issues of the journal, but will also be collected and linked in a kind of dynamically growing library in the form of a virtual special issue and made available for download on the journal's homepage at any time.

Therefore, I would like to invite you to take a look at the Call for Papers on Risk Management in Radiation-Based Therapies on the journal’s homepage (https://www.sciencedirect.com/journal/zeitschrift-fur-medizinische-physik/special-issues) and submit your contributions by the deadline (December 31, 2024). Your contributions will help shape the future of radiation therapy and ensure that it remains a safe and effective treatment option, but also support all medical physicists involved in risk management.
==== Refs
References

1 European Commission, Directorate-General for Energy, General guidelines on risk management in external beam radiotherapy, Publications Office, 2015. https://data.europa.eu/doi/10.2833/667305.
2 Lohmann D. Lang-Welzenbach M. Feldberger L. Risk analysis for radiotherapy at the Universitätsklinikum Erlangen Z Med Phys 32 3 2022 273 282 35012863
3 Pourel N. Meyrieux C. Lisbona A. Quality/risk management system in radiotherapy: changes afoot Cancer Radiother 26 1 2022 14 19 34953695
4 Empfehlungen von BfS, DEGRO, DGMP und DGN zur Risikoanalyse bei therapeutischen Strahlenanwendungen nach Artikel 63 Buchstabe b der EU-Direktive 2013/59/Euratom. 2015. https://www.bfs.de/SharedDocs/Downloads/BfS/DE/fachinfo/ion/empfehlungen-risikoanalyse.pdf?__blob=publicationFile&v=1.
5 DGMP-Bericht 25. Eine Prozessbeschreibung zur Umsetzung des Risikomanagements für die Strahlenbehandlung gemäß §126 StrlSchV. 2022 Arbeitskreis Risikomanagement der Deutschen Gesellschaft für Medizinische Physik e.V. https://cdn.dgmp.de/media/document/4107/2022-DGMP-Bericht-ProzessbeschreibungRisikomanagement.pdf.
6 DGMP-Bericht 28. Eine Durchführungshilfe zur Umsetzung des Risikomanagements für die Strahlenbehandlung gemäß § 126 StrlSchV: Prozessbasierter Ansatz. 2024 Deutsche Gesellschaft für Medizinische Physik e.V. https://cdn.dgmp.de/media/document/4995/20240430-DGMP-Bericht-Durchfuehrungshilfe.pdf.
7 Kornek D, Bert C. Process failure mode and effects analysis for external beam radiotherapy: Introducing a literature-based template and a novel action priority. Z Med Phys 2024, this issue.
8 Buchgeister M. Hummel D. Risikoanalyse in der Strahlentherapie: Muss es die FMEA-Methode mit RPZ sein? Z Med Phys 31 4 2021 343 345 34657782
9 Kornek D, Menichelli D, Leske J, et al. Development and clinical implementation of a digital system for risk assessments for radiation therapy. Z Med Phys 2024, this issue.
10 Wegener S, Exner F, Weick S, et al. Prospective risk analysis of the online-adaptive artificial intelligence-driven workflow using the Ethos treatment system. Z Med Phys 2024, this issue.
11 Wegener S, Käthner P, Weick S, et al. Re-evaluation of the prospective risk analysis for artificial-intelligence driven cone beam computed tomography-based online adaptive radiotherapy after one year of clinical experience. Z Med Phys 2024, this issue.
