van Asten Wim, Markidou Erato Stylianou, Gromoll Christian, Gourzoulidis George A, Maguire Susan, Guidi Gabriele, Pace Eric, Spruijt Hugo, Martinez-Ortega Jaime, Klöck Stephan
EFOMP, The Netherlands.
EFOMP, The Netherlands.
Phys Med. 2023 Apr;108:102557. doi: 10.1016/j.ejmp.2023.102557. Epub 2023 Mar 9.
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.
医学物理专业人员接受与医学实践相关的物理学分支方面的培训。医学物理专业人员拥有扎实的科学背景和技术技能，非常适合在医疗设备生命周期的各个阶段发挥主导作用。医疗设备生命周期的各个阶段包括通过用例评估确定需求、投资规划、医疗设备采购、验收测试（尤其是关于安全性和性能方面）、质量管理、有效且安全的使用与维护、用户培训、与信息技术系统对接，以及医疗设备的安全退役和移除。作为医疗保健机构临床工作人员中的专家，医学物理专业人员在实现医疗设备的平衡生命周期管理方面可以发挥重要作用。鉴于医疗设备的功能及其在常规临床实践和研究中的临床应用严重依赖物理学和工程学，医学物理专业人员与医疗设备及相关物理因素的硬科学方面和先进临床应用密切相关。事实上，这在医学物理专业人员的使命声明中得到了体现[1]。目的：描述医疗设备的生命周期管理以及相关程序。这些程序由医疗保健环境中的多学科团队执行。该工作组的任务重点是阐明并详细说明医学物理学家和医学物理专家（在此统称为医学物理专业人员）在这些多学科团队中的作用。本政策声明描述了医学物理专业人员在医疗设备生命周期各个阶段的作用和能力。如果医学物理专业人员是这些多学科团队的一个组成部分，投资的有效利用、安全性和可持续性可能会提高，同时医疗设备在其生命周期内提供的整体服务质量也会提高。这将带来更好的医疗保健质量并降低成本。此外，这将使医学物理专业人员在整个欧洲的医疗保健机构中拥有更强大的地位。
