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Royal Decree Medical Exposure: Information Obligation, Regulatory Framework


Katrien Van Slambrouck

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How to Cite: Van Slambrouck K. Royal Decree Medical Exposure: Information Obligation, Regulatory Framework. Journal of the Belgian Society of Radiology. 2019;103(1):74. DOI:
  Published on 18 Nov 2019
 Accepted on 06 Sep 2019            Submitted on 03 Sep 2019

A new royal decree for medical exposures of ionising radiation is in the pipeline. This royal decree will replace the current chapter VI of the ARBIS/RGPRI (Koninklijk besluit van 20 juli 2001 houdende algemeen reglement op de bescherming van de bevolking, van de werknemers en het leefmilieu tegen het gevaar van de ioniserende stralingen – Arrêté royal du 20 juillet 2001 portant règlement général de la protection de la population, des travailleurs et de l’environnement contre le danger des rayonnements ionisants). The main goal of the royal decree is the transposition of the new requirements of the Euratom/2013/59 directive; meanwhile some ambiguities in the current legislative texts are resolved.

An important topic in the Euratom directive is the information towards the patient. Article 57 1(d) describes this principles for the patients as well as for their carers and comforters. The directive also specifies in several articles that special attention needs to be given to (possible) pregnancies, exposures of children and interventional procedures when performing radiological examinations.

Giving and obtaining the necessary information starts at the referrer’s, continues when appointments are made as well as when the patient arrives at the radiology department, before the radiological procedure and might even continue after the radiological procedure.

To facilitate the implementation of the new requirements into practice, OLV Aalst-Asse-Ninove, UZ Leuven and FANC are preparing a toolkit. This toolkit will consist of a explicatory document, learning material, supporting communication media (flyers, poster and a movie), as well as an aftercare document in case of interventional procedures with risk of skin effects.

The toolkit gives an overview of a possible information path for ambulant and hospitalised patients and gives guidance for some frequently occurring situations.

The toolkit contains information flyers on discussing the risk of X-rays, the need to talk about pregnancy with female patients and X-ray examinations with children. It also provides learning materials for you and your staff on the possible risks and how to communicate the risks with your patients.

The aim is that radiologists, their staff and the patient feel confident that the procedure to be performed is the right procedure.

Competing Interests

The author has no competing interests to declare.

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