Multi-stakeholder Workshops on Generic Justification and Accidental and Unintended Exposures
The Council Directive 2013/59/Euratom laying down basic safety standards for protection against the dangers arising from exposure to ionising radiation (European BSS) introduces, in the medical field, specific articles relating to two important and complex areas:
- Justification of medical exposures with respect to new types of practices and the interrelation with bio-medical research and early detection of diseases (art. 55 (2))
- Accidental and unintended exposures of individuals subject to medical exposure focusing on specific requirements on notification and recording of significant events (art. 63 in conjunction with art. 96).
Member States have until the 6 February 2018 to complete the process of transposition into their national regulations.
HERCA organised two multi-stakeholder workshops in Paris on the transposition of these challenging issues in the medical field:
- a Workshop on Generic Justification of Medical Exposures using Ionising Radiation (24 noon – 26 noon, October 2016)
- a Workshop on Accidental and Unintended Exposures(26 noon – 27 October 2016)
The objectives of these two workshops were:
- To explore a common understanding of the new BSS requirements
- To exchange on national approaches relating to the implementation of these new BSS requirements;
- To collect the opinion of important European stakeholders, particularly the European medical societies and manufacturers;
- To assist in the development of HERCA Positions Papers intended to facilitate implementation of the BSS.
Institutional and health care professional stakeholders at European and international levels, as well as a patient representative organisation participated.
Workshop on Generic Justification of Medical Exposures using Ionising Radiation (24 noon – 26 noon, October 2016)
Workshop on Accidental and Unintended Exposures(26 noon – 27 October 2016)