(1)

Article 2, point (b), of the Treaty establishing the European Atomic Energy Community (‘Euratom Treaty’) provides for the establishment of uniform safety standards to protect the health of workers and of the general public against the dangers arising from ionising radiation.

(2)

In order to achieve that objective, Article 31 of the Euratom Treaty entrusts the Council with the task of establishing basic standards for the protection of the health of workers and the general public against the dangers arising from ionising radiations on a proposal from the Commission, while Article 32 allows those basic standards to be revised or supplemented.

(3)

The Council has adopted several directives laying down those basic safety standards. The most recent one is Council Directive 2013/59/Euratom (1).

(4)

The standards established by Directive 2013/59/Euratom apply among others to medical radiological practices, where ‘medical radiological’ are defined as pertaining to radiodiagnostic and radiotherapeutic procedures, and interventional radiology or other medical uses of ionising radiation for planning, guiding and verification purposes. Directive 2013/59/Euratom further defines ‘radiodiagnostic’ as pertaining to in-vivo diagnostic nuclear medicine, medical diagnostic radiology using ionising radiation, and dental radiology, and ‘radiotherapeutic’ as pertaining to radiotherapy, including nuclear medicine for therapeutic purposes.

(5)

Article 58, point (e), of Directive 2013/59/Euratom requires Member States to carry out clinical audits in accordance with national procedures. A ‘clinical audit’ is defined as a systematic examination or review of medical radiological procedures which seeks to improve the quality and outcome of patient care through structured review, whereby medical radiological practices, procedures and results are examined against agreed standards for good medical radiological procedures, with modification of practices, where appropriate, and the application of new standards if necessary.

(6)

Medical uses of ionising radiation are an essential component of modern medical diagnosis and treatment which, if conducted appropriately, offer significant benefits to patients and society. At the same time, medical procedures remain by far the largest artificial source of exposure to ionising radiation of Union citizens, with particular safety and quality challenges identified in diagnostic and interventional radiology, radiotherapy, and nuclear medicine procedures.

(7)

It is of paramount importance to ensure effective protection of patients against the potential undesirable effects arising from medical exposure to ionising radiation, as well as of workers and members of the public from associated occupational and public exposures respectively.

(8)

A clinical audit of medical radiological procedures is an essential tool within clinical governance that ensures continuous quality and safety improvement of healthcare services, and thus results in improved healthcare for patients. Ensuring quality and safety of medical applications contributes to the implementation of the Europe’s Beating Cancer Plan (2), which aims to deliver higher-quality care to cancer patients.

(9)

While a clinical audit is an essential part of ensuring quality in healthcare, the use of ionising radiation is only one of the many practices and risks that has to be managed. Moreover, a clinical audit of practices and risks not covered by Directive 2013/59/Euratom, such as contrast agents, magnetic resonance, and ultrasound imaging, would contribute to the overall quality and safety of medical imaging.

(10)

The concept of clinical audit is complementary to, and should not be confused with, inspections performed by the competent authorities, and regulatory audits, which may be performed by the undertaking.

(11)

Experience acquired after many years of implementation of clinical audits across the Community showcases that Member States differ considerably in the way they implement them and face differing challenges in establishing or developing an effective clinical audit infrastructure.

(12)

A recent Commission study (3) found that, despite some progress, clinical audit uptake and implementation still remain variable across the Community. The study concluded that a clinical audit, as defined in Directive 2013/59/Euratom, is most effective when incorporated as a core element of existing clinical audit infrastructure within the wider healthcare system. It further identified common barriers and areas of future work for enhancing the clinical audit uptake and implementation in Member States.

(13)

Good practices, guidance and various resources relating to clinical audits have been developed by Member States, professional bodies, and international organisations, including examples, practical guidelines and manuals in the medical disciplines of radiology, radiotherapy, and nuclear medicine.

(14)

Furthermore, the importance of properly established clinical audits has been emphasized by the Council (4), and further guidance was issued in this area by the Commission (5) and by the Heads of the European Radiological protection Competent Authorities (HERCA) (6).

(15)

It is therefore appropriate to make recommendations for harmonising the provisions applicable in the Member States regarding the implementation of the provisions of Directive 2013/59/Euratom on the clinical audit of medical radiological practices, in order to promote a more harmonised approach at Community level.

(16)

This Recommendation takes into account the positions put forward by the Steering Group on Quality and Safety of medical applications of ionising radiation (‘SGQS’) (7), whose objective is to support the implementation in Member States of activities in the area of quality and safety of medical applications of ionising radiation,