Abstract
Keywords
Introduction
Main elements of the guidelines with a direct impact on the present EFOMP policy statement
EC Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market.
Mission statement for Medical Physicists and Medical Physics Experts
Key activities of Medical Physicists and Medical Physics Experts
Key activity | Main actions |
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Scientific problem solving service. | Comprehensive scientific problem solving service involving recognition of less than optimal performance or optimized use of medical devices, identification and elimination of possible causes or misuse, and confirmation that proposed solutions have restored device performance and use to acceptable status. All activities are to be based on current best scientific evidence or own research when the available evidence is not sufficient. |
Dosimetry measurements (all physical agents e.g., effective dose in ionizing radiation, SAR in MRI, thermal and mechanical indices in ultrasound). | Measurement and calculations of dose received by patients, volunteers in biomedical research, carers, comforters and persons subjected to non-medical procedures using medical devices for the purpose of supporting justification and optimization processes; selection, calibration and maintenance of dosimetry related instrumentation; independent checking of dose provided by dose reporting devices (including software devices); measurement of quantities required as inputs to dose reporting or estimating devices (including software). Measurements to be based on current recommended techniques and protocols. |
Patient safety/risk management (including volunteers in biomedical research, carers, comforters and persons subjected to non-medical procedures using medical devices). | Surveillance of medical devices and evaluation of clinical protocols to ensure the on-going protection of patients, volunteers in biomedical research, carers, comforters and persons subjected to non-medical procedures using medical devices from the deleterious effects of physical agents in accordance with the latest published evidence or own research when the available evidence is not sufficient. Includes optimization, the development of risk assessment protocols, including the analysis of events involving, or potentially involving, accidental or unintended medical exposures to physical agents and dose audit. |
Occupational and public safety/risk management when there is an impact on medical exposure or own safety a Authors' note: When the reduction of occupational and public risk would have an impact on medical effectiveness and exposure to physical agents (e.g., in interventional radiology in which patient and occupational exposure are correlated, or nuclear medicine in which patient, occupational and public risk are correlated) optimization may require input from both an MPE and other experts e.g., Radiation Protection Expert (or an MPE recognized also as RPE). The MP and MPE are always required to have knowledge and skills in occupational radiation protection sufficient to take responsibility for own protection. | Surveillance of medical devices and evaluation of clinical protocols with respect to the protection of workers and public from physical agents when impacting the exposure of patients, volunteers in biomedical research, carers, comforters and persons subjected to non-medical procedures or responsibility with respect to own safety. Correlation of occupational, public and medical exposures – balancing occupational and public risk and patient needs. |
Clinical medical device management. | Provide technical advice and participate in the specification, selection, acceptance testing, commissioning, installation design and decommissioning of medical devices in accordance with the latest published European or International recommendations. The specification, management and supervision of associated quality assurance/control programmes. Design of all testing protocols is to be based on current European or international recommended techniques and protocols. |
Clinical involvement. | Carrying out, participating in and supervising everyday patient physical agent protection and quality control procedures to ensure on-going effective and optimized use of medical devices and including patient specific optimization, prevention of unintended or accidental exposures and patient follow-up. Optimization of protocols before first use with patients via the use of anthropomorphic phantoms and simulation using specialized physical agent dosimetry software. |
Development of service quality and cost-effectiveness. | Support the introduction of new medical devices into clinical service, lead the introduction of new medical physics services and participate in the introduction/development of clinical protocols/techniques whilst giving due attention to economic issues. |
Expert consultancy. | Provision of expert advice to outside clients (e.g., smaller clinics with no in-house medical physics expertise). |
Education of healthcare professionals (including medical physics trainees) | Contributing to quality healthcare professional education through knowledge transfer activities concerning the technical-scientific knowledge, skills and competences supporting the clinically-effective, safe, evidence-based and economical use of medical devices. Participation in the education of medical physics students and organization of medical physics residency programmes. |
Health technology assessment (HTA) | Taking responsibility for the physics component of health technology assessments related to medical devices and/or the medical uses of physical agents. |
Innovation | Developing new or modifying existing devices (including software) and improved use of protocols for the solution of hitherto unresolved clinical problems. |
Qualification framework for Medical Physicists and Medical Physics Experts in Europe
- (a)All qualification frameworks in Europe should be referred to the EQF and the qualification framework for the MP and MPE is based on the levels defined by the EQF. For the purpose of this policy statement the appropriate levels are EQF Level 6 (e.g., Bachelor or equivalent), EQF Level 7 (e.g., Masters or equivalent) and EQF Level 8 (Expert level, highest level of the EQF). The definition of these levels can be found in the EQF. Henceforth the MPE is defined as a clinically qualified MP who has reached EQF level 8 in his/her own specialty of clinical Medical Physics (e.g., Diagnostic and Interventional Radiology, Radiation Oncology, Nuclear Medicine, Physiological Measurement, Neurology, Audiology).
- (b)The qualification framework would make it possible for more individuals to achieve clinically qualified MP and MPE status through its flexibility, cost-effectiveness and lifelong learning approach.
- (c)The qualification framework would facilitate the mobility of the clinically qualified MP and MPE in Europe through an agreed set of minimum criteria for achievement of such status.
- (d)Owing to the rapid expansion of medical device technology and physical agent research publication, it is becoming increasingly difficult for a MP and MPE to become competent in more than one specialty of medical physics; therefore, early specialization has become a necessity and the MP and MPE should be independently recognized in each specialty of medical physics [19,20,21].

Note | Rationale | |
---|---|---|
(i) | The fundamental educational level for medical physics professionals is a level 6 in physics and associated mathematics [1] | Medical Physics professionals need to have good foundations in physics and mathematics as Medical Physics is a physical, numeric and exact science. |
(ii) | ‘Equivalent’ here meaning EQF level 6 with a high level of physics and mathematics content. | This will make it possible for graduates from other Level 6 programmes which include a high level of physics and mathematics (e.g., engineering, biophysics) to enter the field. |
(iii) | The educational entry level for the medical physics professional has been set at EQF level 7. | At entry level the medical physics professional needs to have highly specialized knowledge, critical awareness of knowledge issues in the field, specialized problem-solving skills, ability to manage work contexts that are complex and ability to review the performance of teams [2] . Medical physics professionals require highly specialized knowledge in protection from physical agents and medical devices and specialized problem-solving and troubleshooting skills. The medical physics professional is involved in clinical contexts that may be very complex and reviews the performance of physical agent protection and quality control teams in own specialty of medical physics. |
(iv) | ‘Equivalent’ here meaning EQF level 7 with a high level of physics and mathematics content plus the educational component of the core KSC of medical physics and the educational component of the KSC specific to the specialty of medical physics for which the candidate would be seeking clinical certification. This additional education can be concurrent with the training. | This will make it possible for candidates with Masters in physics, biophysics, engineering etc. to enter the field; however, such candidates need to undertake an additional educational programme which includes the educational component of the core KSC of medical physics and the educational component of the KSC specific to the specialty of medical physics for which the candidate would be seeking clinical certification. |
(v) | The Medical Physicist at entry level is a professional with clinical certification in medical physics i.e., having a level of education in medical physics at a level intermediate between EQF levels 7 and 8, having typically 2 years full-time equivalent accredited clinical training and recognized as competent to act independently through enrollment in a national register for Medical Physicists. | The education and training to clinical certification in medical physics is a necessary foundation for further development to MPE EQF Level 8. |
(vi) | Structured accredited residency based training for clinically based development of the core KSC of medical physics and the KSC specific to the specialty of medical physics for which the candidate would be seeking clinical certification. The duration of this structured training is typically two full-time year equivalents. | A training period of two full-time year equivalents for any one specialty of medical physics is recommended 19 , 20 , 21 |
(vii) | The MPE in a given specialty of medical physics is a clinically qualified Medical Physicist with clinical certification in the specialty who has achieved the highest level of expertise in that particular specialty. The clinically qualified Medical Physicist through structured advanced experience, ongoing extensive CPD and commitment develops the KSC to the highest possible level i.e., EQF level 8. | The qualification level for the MPE has been set at EQF Level 8 because the MPE requires knowledge at the most advanced frontier of a field of work and at the interface between fields, the most advanced and specialized skills and techniques, including synthesis and evaluation, required to solve critical problems in research/innovation and to extend/redefine existing professional practice, demonstrate substantial authority, innovation, autonomy, professional integrity and sustained commitment to the development of new ideas or processes at the forefront of work contexts including research [2] . To carry out activities requiring expert action, involvement or advice with authority and autonomy and which are based on current best evidence (or own scientific research when the available evidence is not sufficient), the MPE requires frontier knowledge in own specialty of medical physics and at the interface between physics and medicine. The MPE requires specialized skills and techniques in protection from physical agents and comprehensive experience regarding the effective and safe use of the medical devices in own specialty, and the synthesis and evaluation skills required to solve critical problems in service development, research, innovation and the extension and redefinition of existing professional practice. |
(viii) | This will mean that to reach MPE status (Level 8) in the specialty area requires a minimum total of four years equivalent clinical training (2 years equivalent of foundation training in the specialty area to certification as Medical Physicist and a further two years equivalent of advanced, structured experience and CPD in the specialty). | It should be emphasized that the further 2 years to reach MPE status must consist of advanced, structured experience and CPD and not simply CPD designed to maintain competence as Medical Physicist. The two years minimum advanced experience must be measured from the time when the advanced experience commences. The advanced experience and CPD might not follow immediately the 2 years of basic training if the candidate is not deemed to be sufficiently prepared. It is to be understood that senior MPEs practicing in large medical centers with a full range of devices would need more years of advanced experience than the 2 years minimum. On the other hand small facilities can be serviced by novice MPEs working under the guidance of a senior MPE. |
(ix) | A person who is currently recognized as an MPE and is in possession of the core KSC of medical physics and the KSC specific to the specialty for which recognition is sought should be deemed to satisfy the requirements for recognition as an MPE if they are currently on active duty as an MPE and are deemed to have reached EQF level 8. | This is a grandparenting clause. |
(x) | This is the requirement for an MPE to maintain recognition. | A five year cycle for re-certification (i.e., recognition as having maintained an EQF level 8 in the particular specialty of Medical Physics) is recommended. |
Curriculum framework for Medical Physicist and Medical Physics Expert educational and training programmes in Europe
- (a)Generic skills consist of transferable skills which are expected of all professionals at a particular level of the EQF. In this case the relevant levels are level 7 [[22]] and level 8 [[23]].
- (b)Subject specific KSC are specific to a profession. These are further classified into sub-categories as determined by the particular profession. In the case of Medical Physics the sub-categories are those specified in Refs. [24,25], that is:
- (i)Medical Physics core KSC: these KSC are expected of all MP/MPEs irrespective of their specialty:
- -KSC for the MP/MPE as physical scientist: these are fundamental physics KSC expected of all physical scientists
- -KSC for the MP/MPE as healthcare professional: these are KSC expected of all healthcare professionals
- -KSC for the MP/MPE as expert in the clinical use of medical devices and protection from associated physical agents: these represent medical device and safety KSC required by all specialties of medical physics.
- -
- (ii)Medical Physics Specialty KSC: these KSC are highly specific to each specialty of medical physics
- (i)

- a.Medical physics textbooks such as the handbooks and training manuals produced by the IAEA for physics in radiation oncology, nuclear medicine and diagnostic and Interventional radiology,
- b.International, European and national legislation including all EU Directives relevant to radiation protection, medical devices, physical agents and personal protective equipment,
- c.Relevant EC reports, recommendations and protocols (e.g., Radiation Protection Series http://ec.europa.eu/energy/nuclear/radiation_protection/medical/publications_en.htm),
- d.Reports, recommendations and protocols from relevant International organizations (e.g., IAEA, IEC, ICRP, ICRU, WHO, UNSCEAR),
- e.Reports, recommendations and protocols from International, European and national medical physics professional bodies (e.g., IOMP, EFOMP, AAPM, IPEM),
- f.Reports, recommendations and protocols from European professional and scientific bodies associated with the specific areas of medical physics practice (e.g., ESTRO, ECR, EANM),
- g.Reports, recommendations and protocols from relevant national authorities (e.g., HPA (UK), STUK (FI))
- h.Primary research reports and review articles from the research literature.
Summary recommendation
Acknowledgments
References
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