Amended proposal for a Council Directive on health protection of individuals against the dangers of ionizing radiation in relation to medical exposures, replacing the Directive 84/466/Euratom
COMMISSION OF THE EUROPEAN COMMUNITIES <tt*-tt •Cr -tt Brussels, 19. 06. 1997 COM(97) 315 final 96/0230 (CNS) Amended proposal for a COUNCIL DIRECTIVE on Health Protection of Individuals Against the Dangers of Ionizing Radiation in Relation to Medical Exposures, Replacing the Directive 84/466/Euratom (presented by the Commission pursuant to Article 189 a (2) of the EC-Treaty) EXPLANATORY MEMORANDUM 1. INTRODUCTION At its sitting of 14 May 1997, the European Parliament gave its opinion on a proposal for a Council Directive (Euratom) on the health protection of individuals against the dangers of ionizing radiation in relation to medical exposures. The proposal was adopted by the Commission on 26 September 1996^ having considered the opinion given by the Economic and Social Committee on 29 May 1996^ on a draft proposal put forward on 24 November 19953. The present modified proposal takes account of the amendments requested by the European Parliament where the Commission has been able to accept them. 2. ACCEPTED AMENDMENTS The Commission accepts amendments n° 1, 2, 3, 4, 5, 7, 8, 9, 10 and 11. The modified Article 1 takes account of amendment 1 in making reference to Directive 96/29/Euratom that shall replace Directive 80/836/Euratom. The modification in Article 2 of the definition of potential exposures simplifies the text as requested by amendment 2. 1 COM(96)465 final, O. J. C341 of 13 November 1996 2 CES 695/96, O. J. C212 of 22. 07. 1996 3 COM(95)560 final 21 Amendment 3 nfodifîes the definition of Medical Physicist in Article 2 by deleting the reference to his responsibilities regarding the protection of Workers and the public. This modification is in line with the aim of this /Directive which is to ensure the protection of persons undergoing medical exposures. Protection of workers and the public in general is ensured by Directive 96/29/Euratom. The simplification of the definition of Quality Assurance in Article 2, as requested by amendment 4, takes account of the fact that the reference to the personnel is redundant because protection of personnel is already covered by Directive 96/29/Euratom. J /' ' The modifîeç} Artièîe 4 takes account of the reference to provisions laid down b/ife Member States as regards the responsibilities of practitioner. / • •/ -; /aadprescriber as requested by amendment 5. On the basis of amendment 7, the modification in Article 4, which deals with exposures without direct health benefit for the person undergoing the exposure, prohibits these exposures if they are not justified. The modification in Article 9, regarding the taking out of service or replacing equipments and instaîlaîio&s which do not comply with acceptability criteria, takes account of amendment 8. The role of the medical physicist in checking equipment used in radiotherapy is strengthened in the modified Article 5, in line with amendment 9. The modified Article 10 includes exposures for radiotkefapeutic purposes as requested by amendment 10. 3> Protection of women in case of exposures of the pelvic and abdominal regions is strengthened in the modified Article 11 as requested by amendment 11. 3. AMENDMENTS WHICH ARE NOT ACCEPTED The Commission cannot accept amendments n° 6 and 12. Amendment 6 proposes to introduce in Article 4 the possibility for every radiological unit to consult a medical physicist. The Commission believes that the procedures for consultation of the medical physicist is sufficiently covered by Article 5, which is more in line with the actual availability of qualified medical physicists in the Union. Amendment 12 replaces the term "practitioner" with "examining doctor" in Article 13. The definition of practitioner given in Article 2, already includes the concept of "examining doctor". H Amended proposal for a COUNCIL DIRECTIVE on Health Protection of Individuals Against the Dangers of Ionizing Radiation in Relation to Medical Exposures, Replacing the Directive 84/466/Euratom COMMISSION'S ORIGINAL PROPOSAL AMENDED PROPOSAL Article 1 Article 1 This Directive lays down the general principles of the radiation protection of individuals undergoing medical exposures and associated practices involving ionizing radiation. This Directive lays down the general principles of the radiation protection of individuals undergoing medical exposures and associated practices involving ionizing radiation. The purpose of this Directive is to supplement Directive 80/836/Euratom on the basic safety standards as regards medical exposures. The purpose of this Directive is to supplement Directive 96/29/Euratom on the basic safety standards as regards medical exposures. Article 2 Article 2 Potential exposures: exposure with a probability of occurrence that can be estimated in advance for accidents and incidents, such as a failure of equipment, a misadministration. a human error or a computer failure; Medical Physicist: an expert in radiation physics applied to medical exposures whose training and competence to act is recognized by the competent authorities and who, as appropriate, gives advice on patient dosimetry, on the development and use of complex techniques and equipment and on optimization, on quality assurance, including quality control, and on matters relating to radiation protection as defined in Article 3, as appropriate. This expert might also give advice on radiation protection aspects as regards workers and the public; Potential exposures: exposure resulting from events such as equipment failure or faults, or a human error and with a probability of occurrence that can be assessed in advance; Medical Physicist: an expert in radiation physics applied to medical exposures whose training and competence to act is recognized by the competent authorities and who, as appropriate, gives advice on patient dosimetry, on the development and use of complex techniques and equipment and on optimization, on quality assurance, including quality control, and on matters relating to radiation protection as defined in Article 3, as appropriate. Quality Assurance: all those planned and systematic actions necessary to provide adequate confidence that a structure, system or component will perform satisfactorily in service. Satisfactory performance in service implies the optimum quality of the entire procedure. Quality Assurance: all those planned and systematic actions necessary to provide adequate confidence that a structure, system or component will perform satisfactorily in service. Satisfactory performance in service implies the optimum quality of the entire procedure. •r In the case of radiodiagnostic procedure, the consistent production of adequate diagnostic information with minimum exposure of both patients and personnel. in the case of a radiotherapeutic procedure optimum exposure of patients and minimum exposure of personnel. By optimum quality is meant: (a) in the case of radiodiagnostic procedure, the consistent production of adequate diagnostic information with minimum exposure of patients. (b) in the case of radiotherapeutic procedure, the optimum exposure of patients. Article 4. 4 Article 4. 4 Special attention shall be given for those exposures where there is no direct health benefit for the person undergoing the exposure and especially for exposures on medico-legal, insurance and legal grounds. Special attention shall be given for those exposures where there is no direct health benefit for the person undergoing the exposure and especially for exposures on medico-legal, insurance and legal grounds. If such an exposure cannot be justified, it should be prohibited Article 4. 5 Article 4. 5 The prescriber as well as the practitioner shall be involved in the justification process, at the appropriate level. The prescriber as well as the practitioner shall be involved in the process of justification taking specific responsibility in accordance with the provisions laid down by the Member State. Article 5. 5 Article 5. 5 In radiotherapeutic practices, a medical physicist shall be closely involved. In diagnostic nuclear medicine practices, a medical physicist shall be involved as appropriate. For other radiodiagnostic practices, a medical physicist shall be available for consultation on optimization and quality assurance, including quality control, as appropriate, and also to give advice on matters relating to radiation protection concerning medical exposures, as required. In radiotherapeutic practices, a medical physicist shall be closely involved and he must check the equipment used for radiotherapy after any major maintenance procedure. In diagnostic nuclear médecine practices, a medical physicist shall be involved as appropriate. For other radiodiagnostic practices, a medical physicist shall be available for consultation on optimization and quality assurance, including quality control, as appropriate, and also to give advice on matters relating to radiation protection concerning medical exposures, as required. G Article 9. b Article 9b Competent authorities shall at regular intervals perform inspections of radiological installations. They shall ensure that necessary measures are taken by the holder of the installation to improve inadequate or defective features of the installation. They shall ensure that all installations which do not or no longer meet specific criteria adopted by competent authorities for this purpose are taken out of service. Competent authorities shall at regular intervals perform inspections of radiological installations. They shall ensure that necessary measures are taken by the holder of the installation to improve inadequate or defective features of the installation. Member States shall adopt measures to ensure that equipment and installations which do not meet predetermined acceptability criteria are taken out of service or replaced. Article 10. 1 Article 10. 1 Member States shall ensure that medical and paramedical staff performing - frequent paediatric medical exposures - exposures as part of a health screening Member States shall ensure that medical and paramedical staff performing - frequent paediatric medical exposures - exposures as part of a health screening programme programme - examinations involving high doses to the patient and the medical staff, such as interventional radiology and Computed Tomography - examinations involving high doses to the patient and the medical staff, such as interventional Computed radiology, Tomography and radiotherapy receive specific training on the relevant radiological practices and on the relevant radiation protection aspects. receive specific training on the relevant radiological practices and on the relevant radiation protection aspects. Article 11. 2 Article 11. 2 If pregnancy cannot be excluded, depending on the type of medical exposures, special attention shall be given to the justification, particularly the urgency, and to the optimization of the medical exposure both for the mother and the unborn child. If pregnancy cannot be excluded, depending on the type of medical exposures, in particular those involving the pelvic and abdominal regions, special attention shall be given to the justification, particularly the urgency, and to the optimization of the medical exposure both for the mother and the unborn child. V ISSN 0254-1475 COM(97) 315 final DOCUMENTS EN «5 06 14 Catalogue number : CB-CO-97-300-EN-C ISBN 92-78-21553-8 Office for Official Publications of the European Communities L-2985 Luxembourg *