Abstract

The aspects of the new European Directive 2013/59/Euratom most relevant to diagnostic imaging and intervention are summarised. The Directive, laying down basic safety standards for protection against the dangers from exposure to ionising radiation, emphasises the need for justification of medical exposure (including asymptomatic individuals), introduces requirements concerning patient information and strengthens those for recording and reporting doses from radiological procedures, the use of diagnostic reference levels, the availability of dose-indicating devices and the improved role and support of the Medical Physics Experts in imaging. Relevant changes include new definitions, a new dose limit for the eye lens, non-medical imaging exposures, procedures in asymptomatic individuals, the use and regular review of diagnostic reference levels (including interventional procedures), dosimetric information in imaging systems and its transfer to the examination report, new requirements on responsibilities, the registry and analysis of accidental or unintended exposure and population dose evaluation (based on age and gender distribution). These changes will require Member States, the radiology community and the industry to adapt regulations, practices and equipment for a high standard of radiation safety. By 6 February 2018, the Directive has to be transposed into the national legislation of the Member States of the European Union.Main messages• The new European Basic Safety Standards Directive impacts radiology departments• Changes in justification, patient information, responsibilities and dose reporting are most significant• Diagnostic reference levels and the role of medical physics experts are clarified• Dose limits to the eye lens are lower than in the previous directive• Responsibilities in radiation safety have been defined

Highlights

  • The new European Directive 2013/59/Euratom [1], laying down basic safety standards (BSS) 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, is expected to have a relevant and positive impact on European radiology

  • This applies to medical doctors, dentists and other health professionals entitled to take clinical responsibility for individual medical exposures, to medical physics experts and to other professionals carrying out practical aspects of medical radiological procedures, such as radiographers and technicians in radiodiagnostic medicine, nuclear medicine and radiotherapy

  • & Member States shall ensure that practitioners and the individuals involved in the practical aspects of medical radiological procedures have adequate education, information and theoretical and practical training for the purpose of medical radiological practices, as well as relevant competence in radiation protection

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Summary

Introduction

The new European Directive 2013/59/Euratom [1], laying down basic safety standards (BSS) 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, is expected to have a relevant and positive impact on European radiology. & Member States shall ensure that practitioners and the individuals involved in the practical aspects of medical radiological procedures have adequate education, information and theoretical and practical training for the purpose of medical radiological practices, as well as relevant competence in radiation protection. 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: 1. Article 58 (procedures), part d, indicates that a medical physics expert shall be involved in radiodiagnostic and interventional radiology practices involving high doses as referred to in point (c) of Art. 61(1) (i.e. interventional radiology and (a) The use of fluoroscopy equipment without a device to automatically control the dose rate, or without an image intensifier or equivalent device, is prohibited. The equipment shall have the capacity to transfer this information to the record of the examination

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