EFOMP policy statement 17: The role and competences of medical physicists and medical physics experts in the different stages of a medical device life cycle.

MPPs are trained in the branches of physics associated with the practice of medicine. Possessing a solid scientific background and technical skills, MPPs are well suited to play a leading role within each stage of a medical device life cycle. The various stages of the life cycle of a medical device include establishment of requirements with use-case assessment, investment planning, procurement of medical devices, acceptance testing especially regarding safety and performance, quality management, effective and safe use and maintenance, user training, interfacing with IT systems, and safe decommissioning and removal of the medical devices. Acting as an expert within the clinical staff of a healthcare organisation, the MPP can play an important role to achieve a balanced life cycle management of medical devices. Given that the functioning of medical devices and their clinical application in routine clinical practice and research is heavily physics and engineering based, the MPP is strongly associated with the hard science aspects and advanced clinical applications of medical devices and associated physical agents. Indeed, this is reflected in the mission statement of MPP professionals [1]. PURPOSE: The life cycle management of medical devices is described as well as the procedures involved. These procedures are performed by multi-disciplinary teams within a healthcare environment. The task of this workgroup was focused on clarifying and elaborating the role of the Medical Physicist and Medical Physics Expert - here collectively referred to as the Medical Physics Professional (MPP) - within these multi-disciplinary teams. This policy statement describes the role and competences of MPPs in every stage of a medical device life cycle. If MPPs are an integral part of these multi-disciplinary teams, the effective use, safety, and sustainability of the investment is likely to improve as well as the overall service quality delivered by the medical device during its life cycle. It leads to better health care quality and reduced costs. Furthermore, it gives MPPs a stronger position in health care organisations throughout Europe.

A collapsed-cone based transit EPID dosimetry method.

PURPOSE: To develop a transit-dose portal dosimetry method based on a commercial collapsed-cone algorithm. METHODS: A Varian Clinac21EX (Varian Medical Systems, USA), equipped with an amorphous-silicon EPID aS1000, was used. Dose calculations were performed with the collapsed-cone algorithm of Pinnacle3 v8.0 m (Philips Medical Systems, USA). A model for the energy of 6 MV was made in Pinnacle3 and afterwards validated for clinical use. A virtual phantom with different densities was contoured and superimposed on the patient images, simulating the presence of the EPID during the treatment. Corrections for photon spectral variations were introduced using Matlab (Mathworks, USA). Transit dosimetry was verified with an anthropomorphic phantom, on which different treatment fields were simulated in locations of skull, thorax and pelvis. In addition, a prostate treatment with IMRT was administered thereon. Dose distributions were compared with gamma index. RESULTS: The dose differences at the central point did not exceed 2%, except for the 20 x 20 cm2 field size centered in the skull. The model presented in this work, assumes that the dimensions of the solid water phantom, are infinite, except for the thickness. The mean values for the gamma index pass rates were 85.62% for (3%, 3 mm), 91.73% (4%, 3 mm) and 95.68% (5%, 3 mm). CONCLUSIONS: The value of 95% for γ (5%, 3 mm) can be established as the value below which the origin of the discrepancies should be investigated. It should be considered that the proposed method is complementary and not a substitute for pre-treatment dosimetry.