2. Main articles of 2013/59/EURATOM highlighting the role and competences of MPP
2.1 Article 4(49): definition of the medical physics expert
2.2 Article 83: medical physics expert
- 1.Member States shall require the medical physics expert to act or give specialist advice, as appropriate, on matters relating to radiation physics for implementing the requirements set out in Chapter VII (‘Medical Exposures’)4and in point (c) of Article 22(4) (‘Practices involving the deliberate exposure of humans for non-medical imaging purposes ‘)5of this Directive.4Chapter VII on Medical Exposures is very extensive and must be studied in depth by MPP as it is full of opportunities for the role to assert itself.5This refers to a new category of practices that make use of medical imaging devices for non-medical purposes defined in the Directive.
- 2.Member States shall ensure that depending on the medical radiological practice, the medical physics expert takes responsibility for dosimetry, including physical measurements for evaluation of the dose delivered to the patient and other individuals subject to medical exposure, give advice on medical radiological equipment, and contribute in particular to the following:
- (a)optimisation of the radiation protection of patients and other individuals subject to medical exposure, including the application and use of diagnostic reference levels;
- (b)the definition and performance of quality assurance of the medical radiological equipment;
- (c)acceptance testing of medical radiological equipment;
- (d)the preparation of technical specifications for medical radiological equipment and installation design;
- (e)the surveillance of the medical radiological installations;
- (f)the analysis of events involving, or potentially involving, accidental or unintended medical exposures;
- (g)the selection of equipment required to perform radiation protection measurements;
- (h)the training of practitioners and other staff in relevant aspects of radiation protection;
- 3.The medical physics expert shall, where appropriate, liaise with the radiation protection expert.
2.3 Article 57: responsibilities
- 1.Member States shall ensure that:
- (b)the practitioner, the medical physics expert and those entitled to carry out practical aspects of medical radiological procedures6are involved, as specified by Member States, in the optimisation process;6“those entitled to carry out practical aspects of medical radiological procedures”: such professionals may be Medical Physicists not yet at expert level, radiographers, dental nurses and others.
2.4 Article 58: procedures
- (d)in medical radiological practices, a medical physics expert is appropriately involved, the level of involvement being commensurate with the radiological risk posed by the practice. In particular:
- (i)in radiotherapeutic practices other than standardised therapeutic nuclear medicine practices, a medical physics expert shall be closely involved;
- (ii)in standardised therapeutical nuclear medicine practices as well as in radiodiagnostic and interventional radiology practices, involving high doses as referred to in point (c) of Article 61(1), a medical physics expert shall be involved;
- (iii)for other medical radiological practices not covered by points (a) and (b), a medical physics expert shall be involved, as appropriate, for consultation and advice on matters relating to radiation protection concerning medical exposure.
2.5 Article 22: practices involving the deliberate exposure of humans for non-medical imaging purposes
- 1.Member States shall ensure the identification of practices involving non-medical imaging exposure, in particular taking into account the practices included in Annex V.
- 4.Where a Member State has determined that a particular practice involving non-medical imaging exposure is justified, it shall ensure that:
- (c)for procedures using medical radiological equipment
- (i)relevant requirements identified for medical exposure as set out in Chapter VII are applied, including those for equipment, optimisation, responsibilities, training and special protection during pregnancy and the appropriate involvement of the medical physics expert;
- (ii)where appropriate, specific protocols, consistent with the objective of the exposure and required image quality, are put in place;
- (iii)where practicable, specific diagnostic reference levels are put in place;
3. Main elements of the guidelines highlighting the role and competences of MPP
3.1 Mission statement for MPP
3.2 Competence profile of MPP
- (a)Medical physics core competences expected of all MPP irrespective of their specialty: these are categorized as competences expected of MPP as physical scientists, those expected of MPP as healthcare professionals and those expected of MPP as experts in the clinical use of medical radiological devices and protection from associated ionising radiations.
- (b)Medical physics competences specific for each medical physics specialty: these competences are highly specific to each specialty of medical physics. It is important to note that an MPP from one specialty of medical physics who is required to assume additional specific competences from another specialty should be certified to carry out those additional responsibilities. Such cases may arise for example in a small nuclear medicine facility which requires its nuclear medicine MPP to take responsibility for the management of quality control testing of the CT component of a PET/CT system or at a small radiation oncology facility which requires its radiation oncology MPE to take responsibility for protocol optimization of a planning CT.
- (a)Scientific problem solving service;
- (b)Dosimetry measurements;
- (c)Patient safety/risk management (including volunteers in biomedical research, carers, comforters and persons subjected to non-medical procedures using medical devices);
- (d)Occupational and public safety/risk management when there is an impact on medical exposure or own safety;
- (e)Clinical medical device management;
- (f)Clinical involvement;
- (g)Development of service quality and cost-effectiveness;
- (h)Expert consultancy;
- (i)Education of healthcare professionals (including medical physics trainees);
- (j)Health technology assessment;
|Key Activity||Main Actions|
|Scientific problem solving service||Comprehensive scientific problem solving service involving recognition of less than optimal performance or optimised 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 ionising 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|
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 would 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 optimised 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 specialised 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 organisation 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||Contribution to scientific and technical advancement in medical physics, by developing new or modifying existing technologies, devices, practices, software, techniques, models, protocols, for improved solutions to diagnosis and treatment of disease|
- (a)Hospitals buy those radiological devices (including radiation sources and software devices) having the technical specifications which would deliver the target clinical patient outcomes at acceptable or, for therapeutic purposes, required patient doses (specification and selection of medical devices) Article 83 (2)(d);
- (b)Radiological equipment delivered to the hospital conforms to the tendered specifications and installed appropriately and safely with respect to patients, volunteers in biomedical research, carers and comforters and persons subjected to non-medical imaging procedures and in liaison with the Radiation Protection Expert safely with respect to staff and the general public (acceptance testing and installation design) Article 83 (2)(c)(d) and Article 83(3); It is to be noted that often the role of the Radiation Protection Expert is held also by MPP. This is proactively encouraged by EFOMP in it’s Malaga Declaration [] particularly since there are many instances when doses to patients and staff or carers are highly correlated e.g., interventional procedures, nuclear medicine. Article 19(4) states specifically that “Practices involving medical exposure shall be justified both as a class or type of practice, taking into account medical and, where relevant, associated occupational and public exposures, and at the level of each individual medical exposure as specified in Article 55”.
- (c)Radiological equipment settings are optimised to the health care needs and characteristics of the local patient population and patient groups, quality control benchmarks are established based on locally available quality control equipment and patient dose values established (commissioning7) Article 83 (2)(a);7The Directive unfortunately does not distinguish between acceptance testing and commissioning, but does assume some aspects of commissioning within the acceptance testing itself.
- (d)Radiological equipment is quality controlled on an ongoing basis and appropriate quality control protocols set-up (management and supervision of device quality control procedures; calibration and verification of measurement instruments; establishment of criteria for acceptable performance; carrying out any quality control procedures involving advanced physics, mathematics and computing) Article 83 (2)(b);
- (e)Written use protocols for every type of standard medical radiological procedure and equipment (as required by Article 58(a))8are optimised in terms of clinical effectiveness, efficiency and reduction of risk to individual patients, specific patient groups, volunteers in biomedical research, carers and comforters. This may include analysis of patient data when this involves advanced physics, mathematics and computing. It also includes liaison with the Radiation Protection Expert to ensure radiation protection of staff and public. Article 83 (2)(a) and Article 83(3);8Article 58(a): “Written protocols for every type of standard medical radiological procedure are established for each equipment for relevant categories of patients”.
- (f)Risks are managed well, unintended or accidental exposures prevented, unintended or accidental exposures (e.g., foetal doses) estimated and recommendations put forward to avoid future repeats. The scope includes risks incurred by carers and comforters and by volunteers in medical or biomedical research. Article 83 (2)(e)(f) and Article 4(48)9.Article 4(48) “medical exposure means exposure incurred by patients or asymptomatic individuals as part of their own medical or dental diagnosis or treatment, and intended to benefit their health, as well as exposure incurred by carers and comforters and by volunteers in medical or biomedical research”.109Article 4(48) “medical exposure means exposure incurred by patients or asymptomatic individuals as part of their own medical or dental diagnosis or treatment, and intended to benefit their health, as well as exposure incurred by carers and comforters and by volunteers in medical or biomedical research”.10This would include also the setting up of dose constraints (Article 6(1)(c) “for medical exposure, dose constraints shall apply only with regard to the protection of carers and comforters and volunteers participating in medical or biomedical research”.)
- (g)Patient risk indicators are measured accurately and monitored (external and internal dosimetry and dose monitoring including the establishment of DRL). Article 83 (2) and Article 83 (2)(a)(g);
- (h)Surveillance of medical radiological installations is carried out in an ongoing manner and unsafe devices are decommissioned. Article 83 (2)(e);
- (i)All healthcare professionals are well trained with regard to technical aspects of optimised radiological medical device use and radiation protection. Article 83 (2)(h).
- (a)It is in the form of a written protocol;
- (b)It was developed by a multi-disciplinary team which included as a minimum a physician practitioner, an MPE in the specialty and a senior user;
- (c)It’s development is well-documented and based on international guidelines and current published best evidence (alternatively, when no international guidelines or published best evidence have been available, local research has been carried out to support the practice with the provision that the practice should be revised when international guidelines or published best practice become available);
- (d)It has been updated at appropriate intervals;
- (e)It is not currently under modification;
- (f)It is used in situations with mostly predictable outcome in both efficacy and (low risk of) toxicity, and patient quality-of-life;
- (g)The protocol includes a list of specific circumstances under which the physician practitioner and/or MPE should be contacted for action and/or advice.
- (h)It involves the use of a registered radiopharmaceutical within its authorised clinical application.
5. Role development
- Caruana C.J.
- Cunha J.A.M.
- Orton C.G.
- Delis H.
- Christaki K.
- Healy B.
- Loreti G.
- Poli G.L.
- Toroi P.
- et al.
6. Independent medical physics services
7. Summary recommendations
EC. COUNCIL DIRECTIVE 2013/59/EURATOM of 5 December 2013 laying down basic safety standards for protection against the dangers arising from exposure to ionising radiation, and repealing Directives 89/618/Euratom, 90/641/Euratom, 96/29/Euratom, 97/43/Euratom and 2003/122/Euratom.
EC. Directive 1997/43/Euratom of 30 June 1997 on health protection of individuals against the dangers of ionizing radiation in relation to medical exposure.
EC. RP174 European Guidelines on the Medical Physics Expert; 2014.
European Parliament and Council. Recommendation 2008/C 111/01 on the establishment of the European Qualifications Framework for lifelong learning.
- The changing concept of competence and categorisation of learning outcomes in Europe: implications for the design of higher education radiography curricula at the European level.Radiography. 2011; 17: 230-234
EFOMP’s position on medical physics in Europe, 2006 (‘Malaga Declaration’).
- The conflict between treatment optimization and registration of radiopharmaceuticals with fixed activity posology in oncological nuclear medicine therapy.Eur J Nucl Med Mol Imaging. 2017; 44: 1783-1786
- The evidence base for the use of internal dosimetry in the clinical practice of molecular radiotherapy.Eur J Nucl Med Mol Imaging. 2014; 41: 1976-1988
- EFOMP Policy Statement No 14: the role of the Medical Physicist in the management of safety within the magnetic resonance imaging environment: EFOMP recommendations.Phys Med. 2013; 29: 122-125
- A strategic development model for the role of the biomedical physicist in the education of healthcare professionals in Europe.Phys Med. 2012; 28: 307-318
- A comprehensive SWOT audit of the role of the biomedical physicist in the education of healthcare professionals in Europe.Phys Med. 2010; 26: 98-110
- Subjects such as strategic planning, extra-disciplinary communication, and management have become crucial to medical physics clinical practice and should become an integral part of the medical physics curriculum.Med Phys. 2017; 44: 3885-3887https://doi.org/10.1002/mp.12211
- Moving beyond quality control in diagnostic radiology and the role of the clinically qualified medical physicist.Phys Med. 2017; 41 (Epub 2017 Apr 12): 104-108https://doi.org/10.1016/j.ejmp.2017.04.007
- Nuclear and radiological emergencies: building capacity in medical physics to support response.Phys Med. 2017; 42: 93-98