The new European Directive laying down basic safety standards for protection against the dangers arising from ionising radiation exposure will come into effect on 6 February 2018. The most relevant change for interventionists in the occupational exposure section is the new annual limit for the lens of the eyes (20 mSv/year, instead of 150 mSv/year), write Eliseo Vano (Madrid, Spain) and Gabriel Bartal (Kfar Saba, Israel).
With this new radiation safety legislation coming into effect soon, the Radiation Protection Pavilion at the Cardiovascular and Interventional Radiological Society of Europe’s annual meeting in Denmark was a timely and interactive awareness campaign for radiation protection and dose management.
The new European Directive 2013/59/Euratom laying down basic safety standards for protection against the dangers arising from exposure to ionising radiation is expected to have a relevant impact on European diagnostic and interventional radiology. The Directive was adopted by the Council of the European Union (EU) on 5 December 2013. Member States of the European Union are required to complete the transposition of the Directive into national legislation by 6 February 2018. After the transposition, the implementation of the new requirements will represent a serious challenge for the interventional practices in Europe, but is expected to substantially improve the radiation exposure safety for patients, as well as personnel.
The most relevant changes in the new Directive (with impact on interventional practices) in comparison to the existing ones may be summarised as follows: Use and regular review of diagnostic reference levels (DRLs) including interventional procedures; Education and training (not included in the chapter on medical exposures); Responsibilities (involvement of several professionals in optimisation); Role of medical physics experts in diagnostic and interventional procedures; New requirements for equipment; Procedures: optimisation process, clinical protocols and clinical audit; Registry and analysis of accidental or unintended exposures of the patients. The most relevant change in the occupational exposures is the new annual limit for the lens of the eyes (20 mSv/year instead of 150 mSv/year).
The use and regular review of diagnostic reference levels is a new requirement. Appropriate local reviews are needed whenever diagnostic reference levels are consistently exceeded and require corresponding corrective action without undue delay. The impact of complexity factors when setting diagnostic reference levels in interventional procedures will be a challenge and implemented gradually with the transition to new angiography equipment.
Member States shall ensure that practitioners and the individuals involved in the practical aspects of medical radiological procedures have relevant competence in radiation protection. Appropriate curricula need to be established and corresponding diplomas, certificates or formal qualifications, recognised. Continuing education and training after qualification need to be provided and especially when new techniques are introduced.
With regards to responsibilities, it is stressed that any medical exposure takes place under the clinical responsibility of a practitioner and that the practitioner, the medical physics expert and those entitled to carry out practical aspects of the procedures shall be involved in the optimisation process.
The Directive contains new requirements for equipment: Any equipment used for interventional radiology shall have a device or a feature informing on the quantity of radiation produced by the equipment during the procedure and shall have the capacity to transfer the dosimetric information to the record of the examination (equipment installed prior to 6 February 2018 may be exempted from this requirement). Member States shall ensure that “Information relating to patient exposure forms part of the report of the medical radiological procedure”.
It is also required to give information to the referrer, the practitioner, and the patient or their representative, about clinically significant unintended or accidental exposures and the results of the analysis and to declare them as soon as possible to the competent authority.
Eliseo Vano is a professor at the Department of Medical Physics Service, Radiology Department, San Carlos Hospital, Complutense University Madrid, Spain.
Gabriel Bartal is director, Department of Medical Imaging and Interventional Radiology at Meir Medical Center, Kfar Saba, Israel.
The authors have reported no disclosures pertaining to the article.
- European Council Directive 2013/59/Euratom on 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. OJ of the EU. L13; 57: 1–73 (2014).
- European Society of Radiology (ESR). Summary of the European Directive 2013/59/Euratom: essentials for health professionals in radiology. Insights Imaging. Aug; 6(4): 411–417 (2015).
- Vano, E. Radiation Protection: Are you prepared for the new legislation in 2018? Hot Topic Symposium. Radiation Protection: Burning Issue. CIRSE 16–20 September, Copenhagen, Denmark. (2017).