Reporting of Accidental and Unintended Medical Exposures
On 12th May 2017, on the occasion of the 19th meeting of the association HERCA which brings together the Heads of European Radiological protection Competent Authorities, HERCA has approved a Position Paper “Accidental and Unintended Medical Exposures”.
While use of medical radiation is in general conducted to the highest standards of safety, there are occasions when accidental and unintended medical exposures occur, as is the case for other adverse events in medicine. As part of the transposition process for Council Directive 2013/59/Euratom laying down basic safety standards for protection against the dangers arising from exposure to ionizing radiation (BSS-Euratom), for the first time Member States are required to put in place a regulatory system to address such exposures. The Directive identifies that different requirements are necessary to respond to:
(1) all medical exposures involving or potentially involving accidental or unintended medical exposures – where analysis and record keeping is appropriate
(2) clinically significant unintended or accidental exposures – where the patient or others and professional staff associated with the care of the patient should be informed
(3) significant events as defined by the competent authority – where reporting to the competent authority is required
and that mechanisms should be in place to share information regarding significant events.
HERCA has conducted surveys and a multi-stakeholder workshop (October 2016) to discuss these requirements and to inform this publication. The outcomes of these, and deliberations of the HERCA Working Group on Medical Applications have resulted in a Position Paper which includes its key findings and 7 key messages. These include the roles of professional bodies and competent authorities with regard to significant and therefore reportable events and other exposures. The paper postulates that different approaches are required for events involving diagnostic and radiotherapeutic exposures. Other common factors are highlighted for consideration by Member States and others, although no single reporting approach will be possible for the whole of Europe.