S3002
Invited Speaker
ESTRO 2026
5324 A European survey on current practices of in-house medical device software (MDSW) development, management and use in medical physics Christina Zacharatou 1 , Antonio Sarno 2 , Eric Pace 3 , Miguel Angel Suero Rodrigo 4 , Egbert Hovenkamp 5 , Christian Rønn Hansen 6 , Oliver S. Grosser 7 , Jacob Graversen Johansen 8 , Yiannis Roussakis 9 , Dimitris Visvikis 10 , Peter Bernhardt 11,12 , Andre Dekker 13 1 Department of Medical Physics, St Luke's Radiation Oncology Network, Dublin, Ireland. 2 Department of Physics, University of Milano, 20133 Milano, Italy. 3 Medical Physics, Faculty of Health Sciences, University of Malta, Msida MSD2080, Malta. 4 Department of Medical Physics, Cáceres University Hospital, Cáceres, Spain. 5 Department of Regulatory Affairs, Bayer Medical Care B.V., Maastricht, Netherlands. 6 Department of Oncology, Odense University Hospital, Odense, Denmark. 7 Department of Radiology and Nuclear Medicine, Otto-von-Guericke- University, Magdeburg, Germany. 8 Danish Centre for Particle Therapy, Aarhus University Hospital, Aarhus, Denmark. 9 Department of Medical Physics, German Oncology Center, Limassol, Cyprus. 10 National Institute of Health and Medical Research, LaTIM-Laboratory of Medical Information Processing (INSERM LaTIM), Université Bretagne Occidentale, Brest, France. 11 Department of Medical Radiation Sciences, Institute of Clinical Sciences, Sahlgrenska Academy at University of Gothenburg, Gothenburg, Sweden. 12 Department of Medical Physics and Biomedical Engineering (MFT), Sahlgrenska University Hospital, Gothenburg, Sweden. 13 Department of Radiation Oncology (MAASTRO), School for Oncology and Developmental Biology, Maastricht University Medical Centre, Maastricht, Netherlands
References: Macchia G, Sturdza AE, Lancellotta V, Fragomeni SM, Taylor A, Creutzberg CL, Fischerová D, Tagliaferri L, Oonk M, Garganese G. From evidence to practice: Real-world implementation of ESGO 2023 guidelines for adjuvant radiotherapy in vulvar cancer. Radiother Oncol. 2026 Mar 7;219:111477. doi: 10.1016/j.radonc.2026.111477. Oonk MHM, Planchamp F, Baldwin P, Mahner S, Mirza MR, Fischerová D, Creutzberg CL, Guillot E, Garganese G, Lax S, Redondo A, Sturdza A, Taylor A, Ulrikh E, Vandecaveye V, van der Zee A, Wölber L, Zach D, Zannoni GF, Zapardiel I. ESGO Guidelines for the Management of Patients with Vulvar Cancer - Update 2023. Int J Gynecol Cancer. 2023 Jul 3;33(7):1023-1043. doi: 10.1136/ijgc-2023-004486. 5323 Controversies or questions in adjuvant vulvar cancer: The surgical point of view Ate G.J. van der Zee Department of Obstetrics and Gynecology, University Medical Center Groningen, Groningen, Netherlands Current surgical standard of care for early stage vulvar cancer will be presented and the rationale for adjuvant therapy for improved local and regional (groins) control. Two different types of vulvar cancer (HPV and non-HPV) exist, but despite differences in their biological behavior sofar no consequences for diagnostic or therapeutic strategy have been implemented. After radical local excision local recurrences frequently occur with only involved pathological margins as a strict indication for additional therapy (either re-excision or radiotherapy). In patients with a negative sentinel node groins’ control is excellent and no further therapy is warranted. In patients with any presence of tumor in the sentinel node further therapy is indicated: radiotherapy to the groins appears to be equally effective as inguinofemoral lymphadenectomy, but associated with less treatment-related morbidity. In patients with a sentinel node metastasis > 2 mm inguinofemoral lymphadenectomy is first choice of additional therapy. Whether chemoradiation is equally effective in these patients is currently explored in the ongoing GROINSS-V 3 trial. As vulvar cancer is a rare disease treatment should be centralized and performed by an experienced team in a comprehensive cancer center.
Introduction A European-wide survey by the Joint
EFOMP/ESTRO/ESR/EANM Working Group was conducted to investigate the influence of the EU Medical Devices Regulation (MDR 2017/745) on the practice of the development, management and use of Medical Device Software (MDSW). The outcome of the survey would highlight what uncertainties remain and identify areas that require improvement. Method The survey targeted Medical Physics Professionals (MPP), engineers, IT or regulatory experts working in clinical, academic, government/regulator, or industry roles, and who are involved in the development/use of software related to their activities. The scope of the survey was limited to in-house MDSW, defined as a device that is manufactured and used only within a health institution/legal entity
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