Optimization of radiation protection in radiodiagnostic imaging: the EU context Georgi Simeonov Esch-sur sur-alzette, 20 January 2010 1
European Radiation Protection Legislation (1) Euratom Treaty, Rome, 25 March 1957 Article 2: the Community shall establish uniform standards to protect the health of workers and of the general public 2
European Radiation Protection Legislation (2) Basic Safety Standards (BSS) from 1959 Directive to 96/29/Euratom Directive 97/43/Euratom on medical exposure (MED) BSS being recast with MED and three other Euratom Directives 3
Directive 97/43/EURATOM Replaces EU Directive 84/466/Euratom Patients, health screening, (bio)medical research and carers and comforters Also covers occupational health surveillance and medico-legal procedures Protection based on principles of Justification and Optimization 4
Optimization of protection in MED (1) Article 4, Optimization All doses due to medical exposure for radiological purposes except radiotherapeutic procedures shall be kept ALARA consistent with obtaining the required diagnostic information, taking into account economic and social factors. 5
Dose levels in medical radiodiagnostic practices or, in the case of radio-pharmaceuticals, levels of activity, for typical examinations for groups of standard-sized patients or Optimization of protection in MED (2) standard phantoms for broadly defined types of equipment. These levels are expected not to be exceeded for standard procedures Member when States good and shall: normal practice regarding diagnostic and technical performance is applied. Promote the establishment and the use of diagnostic reference levels (DRL) for radiodiagnostic examinations, and the availability of guidance for this purpose having regard to European diagnostic reference levels where available. A restriction on the prospective doses to individuals which may result from a defined source, for use at the planning stage in radiation protection whenever optimization is involved. Ensure that dose constraints are established for carers and comforters and for volunteers in research. 6
Optimization of protection in MED (3) The optimization process shall include: selection of equipment, consistent production of adequate diagnostic information as well as the practical aspects, quality assurance including quality control and the assessment and evaluation of patient doses or administered activities, taking into account economic and social factors. 7
Optimization of protection in MED (4) Article 6, Procedures Written protocols for every type of standard radiological practice shall be established for each equipment. Clinical audits shall be carried out in accordance with national procedures. Local reviews are undertaken whenever DRL are consistently exceeded and corrective actions are taken where appropriate. 8
Optimization of protection in MED (5) Responsibilities (Articles 5 and 6) Member States shall ensure that any medical exposure is effected under the clinical responsibility of a practitioner. For other radiological practices (no RT nor NM), a MPE shall be involved, as appropriate, for consultation on optimization including patient dosimetry and QA, and also to give advice on matters relating to radiation protection concerning medical exposure, as required. The practical aspects for the procedure or part of it may be delegated to one or more individuals entitled to act in this respect in a recognized field of specialization. 9
Optimization of protection in MED (6) Article 7, Training (1) MS shall ensure that practitioners, MPE and those individuals dealing with practical aspects have adequate theoretical and practical training for the purpose of radiological practices, as well as relevant competence in radiation protection. For this purpose MS shall ensure that appropriate curricula are established and shall recognize the corresponding diplomas, certificates or formal qualifications. 10
Optimization of protection in MED (7) Article 7, Training (2) MS shall ensure that continuing education and training after qualification is provided and, in the special case of the clinical use of new techniques, the organization of training related to these techniques and the relevant radiation protection requirements. MS shall encourage the introduction of a course on radiation protection in the basic curriculum of medical and dental schools. 11
Optimization of protection in MED (8) Article 8, Equipment Member States shall ensure that appropriate QA programmes including quality control measures and patient dose or administered activity assessments are implemented by the holder of the radiological installation. If new radiodiagnostic equipment is used, it shall have, where practicable, a device informing the practitioner of the quantity of radiation produced by the equipment during the radiological procedure. 12
Optimization of protection in MED (9) Article 9, Special Practices MS shall ensure that appropriate radiological equipment, practical techniques and ancillary equipment are used for the medical exposure of children, as part of a health screening programme, involving high doses to the patient, such as interventional radiology, computed tomography or radiotherapy. Special attention shall be given to the QA programmes, including quality control measures and patient dose or administered activity assessment. MS shall ensure that practitioners and those individuals performing the exposure obtain appropriate training on these radiological practices 13
EC Guidelines (1) DG TREN Radiation Protection web-page http://ec.europa.eu/energy/nuclear/radiation_protection/publications_en.htm ions_en.htm 14
EC Guidelines (2) DG TREN Radiation Protection web-page 109: Diagnostic Reference Levels, 1999 116: Education E and training in radiation protection for medical exposures,, 2000 119: Radiation Protection Training in Interventional Radiology (MARTIR), 2000 159: Clinical Audit, 2009 15
EC Guidelines (3) EC Research Programmes Quality criteria for diagnostic radiographic images, 1996 Quality criteria for diagnostic radiographic images in paediatrics, 1996 Quality criteria for computed tomography, 1997 QA in mammography screening, 3rd Edition, 2001 16
Ongoing EC work (1) European Medical ALARA Network (EMAN) stakeholders network on optimization of protection in medical exposure launched in October 2009, 3 year support by EC topics for (initial consideration): Optimization of protection in CT Interventional radiology X-ray outside radiology room 17
Ongoing EC work (2) Framework Programme 7 Breast CT: Dedicated CT of the female breast http://www.imp.uni-erlangen.de/breastct erlangen.de/breastct/ SEDENTEXCT: New and emerging dental X-ray modality http://www.sedentexct.eu 18