Medical Applications | Application of the justification principle/ Justification of Individual Medical Exposures for Diagnosis: A HERCA Position Paper

On 12 June 2014, on the occasion of the 13^th meeting of the association HERCA which brings together the Heads of European Radiological protection Competent Authorities, HERCA has approved the document “ Justification of Individual Medical Exposures for Diagnosis: A HERCA Position Paper “ The document is intended to provide the regulator’s view on the roles and responsibilities in the justification process of medical exposures. Improving the application of the justification principle in medical imaging is the responsibility of many stakeholders. In doing so the position paper considers the requirements of the new European Basic Safety Standards (BSS) Directive 2013/59/Euratom¹ and discusses a number of emerging challenges associated with efficient, effective and rapidly changing healthcare systems.

In summary

• the justification process should be completed prior to the exposure taking place and include consideration of the following:
  • adequate information regarding the clinical condition(s) of the patient, relevant to the imaging request -this must be available including known possible contraindications (eg pregnancy, breastfeeding)
  • the diagnostic question(s) to be addressed
• where practicable, information, with regard to possible previous/concurrent examinations
• the decision on the appropriate imaging procedure including the option of one that does not involve ionizing radiation
• traceability of the above to the referrer and practitioner,
• the role of the regulator is to provide, through regulations and associated guidance, a clear and unambiguous regulatory framework including requirements for the justification process and accountability within local procedures – these will be subject to inspection,
• the role of the undertaking and the professionals involved is to demonstrate compliance with regulations through procedures and documentation associated with each individual exposure, showing beyond reasonable doubt that the elements of the justification process have been completed, and by whom, in accordance with the responsibilities laid down in procedures.

The position paper concludes that appropriate justification processes offer the most effective method to achieve dose reduction in medical imaging, for the individual and for the exposed population. HERCA is committed to providing clarity regarding the regulatory frameworks within which clinical professionals involved in medical exposures conduct their clinical practice and to working together with professional bodies and organizations in order to provide a safe environment for the medical exposures of patients.