Systematizing the risk management process in clinical radiotherapy practice: Recommendations of the working group on risk management of the DGMP

Sep 29, 2026

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The Deutsche Gesellschaft für Medizinische Physik (DGMP) has published two reports (No. 25 and No. 28) that describe how to design and implement a risk management process in German radiotherapy departments. The study summarizes the multi-year development work: weekly meetings of experienced medical physicists produced FMEA-derived recommendations usable across clinic sizes. It applies a process-based method to identify hazardous breast radiotherapy scenarios under surface guidance and DIBH, using three criticality approaches. Peer review by radiation oncologists and MPs supports practical adoption.

LanguageEnglish

CategoryResearch & Report

FormatPDF

Pages7

Reading Time18 min

AccessFree to download

Introduction

Methods and Materials

Results

Conclusions

| Original Paper
Systematizing the risk management process in clinical radiotherapy practice: Recommendations of the working group on risk management of the DGMP
Dominik Kornek a,b,⁎, Cordelia Hoinkis c, Natasa Milickovicd, Ailine Lange e, Alena Knak f, Manuel März g, Mieke L. Möller h, Markus Buchgeisteri
a Department of Radiation Oncology, Universitätsklinikum Erlangen, Friedrich-Alexander-University Erlangen-Nürnberg (FAU), 91054 Erlangen, Germany b Comprehensive Cancer Center Erlangen-EMN (CCC ER-EMN), 91054 Erlangen, Germany
c Department of Radiotherapy and Radiation Oncology, Faculty of Medicine University Hospital Carl Gustav Carus, Technische Universität Dresden (TUD), 01307 Dresden, Germany d Department of Medical Physics and Engineering, Radiation Oncology Clinic, Sana Klinikum Offenbach, 63069 Offenbach, Germany
e MVZ Prüner Gang, 24103 Kiel, Germany
fKlinik für Strahlentherapie, Klinikum Herford, 32049 Herford, Germany
g Department of Radiotherapy, Regensburg University Medical Center, 93053 Regensburg, Germany h Radiologische Allianz Hamburg, 20357 Hamburg, Germany
i Faculty of Mathematics-Physics-Chemistry (II), Berliner Hochschule für Technik (BHT), 13353 Berlin, Germany | | | | --- | --- | --- | | A R T I C L E I N F O | | A B S T R A C T | | Keywords:
Risk management FMEA Radiotherapy Best practice Patient safety | | Purpose: The Deutsche Gesellschaft für Medizinische Physik [German Society of Medical Physics] has recently published two coherent reports, No. 25 and No. 28, detailing the design and implementation of a risk management (RM) process for German radiotherapy (RT) departments. This study offers an overview and background of the efforts behind these reports.
Methods and Materials: For three years, up to nine medical physicists (MPs) with practical RM experience held weekly meetings to develop recommendations for a clinical RM process. Care was taken to ensure that the recommendations were equally applicable to RT departments of various sizes. A process-based method derived from the failure mode and effects analysis (FMEA) was created to identify and address risks from unintentional radiation exposure. This method was applied to exemplarily analyze the hazardous scenarios in breast RT using surface guidance and deep inspiration breath hold (DIBH) techniques. Three common criticality methods—risk matrix, risk priority number, and action priority—were applied, and each step was schematically explained for ﬁrst-time users. Each report was peer-reviewed by two radiation oncologists and 11 MPs.
Results: In report No. 25, basic requirements were outlined for running the RM process, conducting risk assessments, and monitoring clinical procedures. A three-year plan-do-check-act cycle was proposed for continuous improvement. In report No. 28, general process lists for external beam radiotherapy (EBRT), brachytherapy, and radionuclide therapy were designed. Based on the EBRT process list, 45 hazardous scenarios in the surface-guided breast RT in DIBH were identiﬁed. Two scenarios were used to illustrate handling instructions for the three criticality methods.
Conclusions: The recommendations provide clinical MPs and other health professionals with a pragmatic approach to RM, balancing both the needs of smaller practices and larger clinics in Germany. The risk of unintended exposures of patients is viewed acceptable once it has been lowered to a state that is as low as reasonably achievable. | ⁎ Corresponding author. Dominik Kornek. Department of Radiation Oncology, Universitätsklinikum Erlangen, Friedrich-Alexander-University Erlangen-Nürnberg (FAU), 91054 Erlangen, Germany E-mail addresses: [dominik.kornek@tuta.io](dominik.kornek@tuta.io), [dominik.kornek@uk-erlangen.de](dominik.kornek@uk-erlangen.de) (D. Kornek), cordelia.hoinkis@ukdd.de (C. Hoinkis), [natasa.milickovic@sana.de](natasa.milickovic@sana.de) (N. Milickovic), [ailine.lange@gmx.de](ailine.lange@gmx.de) (

FAQs

What reports from DGMP form the basis of the study?

The study is based on two coherent DGMP reports: No. 25 and No. 28, which outline design and implementation of risk management processes for German radiotherapy departments.

How were the recommendations developed?

Over three years, up to nine medical physicists with practical risk management experience held weekly meetings to create recommendations for a clinical risk management process, ensuring applicability to different department sizes.

Which risk analysis techniques were used in the example application?

A process-based method derived from FMEA was applied, and three criticality methods were used: risk matrix, risk priority number, and action priority, with step-by-step schematics for first-time users.

Sep 29, 2026

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