This month's comprehensive EU affairs update includes news about the EU medical devices regulation, our "radiologist's summary" of the Basic Safety Standards directive, and continued efforts to raise awareness of patient safety and quality of care.
Update on EU medical devices regulation
After one and a half years of negotiations, the EU Council reached agreement on a general approach (please see the Medical devices press release in the links section) regarding the medical devices and in-vitro medical devices regulations at the June 19 meeting of its Employment, Social Policy, Health and Consumer Affairs (EPSCO) configuration, paving the way for negotiations with the European Parliament.
The approach set out in the Latvian presidency proposals contains compromises on strengthening the rules for the designation and monitoring of notified bodies, tasking notified bodies with carrying out unannounced inspections, as well as manufacturers’ responsibilities for post-market surveillance and publishing summaries of the safety and performance of high risk devices. The Council also agreed on the introduction of unique device identifications to be registered at a central database to ensure traceability.
As for the scrutiny procedure of medical devices, the Council’s position will in essence preserve the current system of evaluation by notified bodies instead of the more extensive pre-market authorisation process favoured by the European Parliament.
The Council’s overall approach is closer to the European Commission’s original legislative proposal than the position adopted by the European Parliament, which will now have to be reconciled through trilogue negotiations.
The rapporteur for the medical devices regulation in the European Parliament, Glenis Willmott (S&D/UK), welcomed the fact (please see the second link in the links section) that the Council was getting ready to start negotiations, but pointed out that significant differences between the institutions’ positions remain.
ESR BSS directive summary
The ESR’s Radiation Protection Subcommittee has developed a radiologists’ summary (see the links section for further information) of the European Basic Safety Standards (BSS) directive (Directive 2013/59 Euratom) that will be transposed into national law by EU Member States by February 6, 2018. This paper, published in Insights into Imaging, provides a concise overview of those parts of the directive relevant to radiologists, to help them understand the legislation’s impact on radiology departments and new requirements that must be complied with.
The new Euratom directive is a significant overhaul of European radiation protection legislation as it consolidates the five current Euratom directives (including Directive 97/43 on medical exposure) into a single piece of legislation. The BSS directive emphasises the need and clarifies responsibilities for justification, outlines procedures such as optimisation processes, clinical protocols and clinical audit, and introduces new requirements on patient information. It further reinforces rules for recording and reporting doses as well as the use of diagnostic reference levels.
The radiologists’ summary of the BSS directive is part of the ESR’s active efforts to work with EU institutions and regulators during the transposition phase to ensure the radiology profession’s viewpoints are taken into account as laws, regulations and practices are adapted to the new requirements in order to ensure the highest standards of safety for patients across Europe.
Update on the activities of the ESR Patient Advisory Group
The ESR Patient Advisory Group (ESR-PAG), launched at the European Congress of Radiology (ECR) in 2013, aims to bring together patients, the public and imaging professionals to positively influence advances in the field of medical imaging and to foster a patient-centred approach in the work of ESR.
ESR-PAG is chaired by Nicola Bedlington, secretary general of the European Patients’ Forum (EPF) and the ESR’s Communications and External Affairs Committee chair Prof. Boris Brkljačić serves as vice-chair of the group. Besides four more ESR representatives, the ESR-PAG includes representatives from EuropaDonna (the European Breast Cancer Coalition), EuropaUomo (the European Prostate Cancer Coalition, the European Federation of Crohn’s Ulcerative Colitis Associations (EFCCA), the European Federation of Neurological Associations (EFNA), the Stroke Alliance for Europe (SAFE), the Pelvic Pain Support Network (PPSN) and the European Federation of Radiographers Societies (EFRS).
One of the group’s core goals is the ‘involvement of patient representatives in strategic decisions regarding medical imaging and the collaboration with relevant ESR committees and subcommittees’. The ESR-PAG has therefore developed a ‘driver diagram on patient-centred care’ in close collaboration with the ESR Audit & Standards Subcommittee. The driver diagram is intended to provide examples of best practices and improve quality of care, and was launched during ECR 2015 in Vienna.
The ESR-PAG will continue its active involvement in the ECR and two further sessions on the implementation of the driver diagram, as well as the future of health research in the context of the planned EU data protection regulation, are planned for 2016.
Since its establishment in 2013, the group has contributed to the International Day of Radiology (IDoR), taking place each year on November 8th. This year, the day will be dedicated to paediatric imaging.
For further information on the ESR Patient Advisory Group’s activities as well as useful related links, please see the links section to the right.
ESR continues efforts to raise awareness of patient safety and quality of care at EU level
Improving safety and quality of care for patients is one of the top priorities of the ESR, which has led to the development of initiatives such as the EuroSafe Imaging Campaign to promote radiation protection as well as the ESR Action Plan for Medical Imaging, which was launched at the European Parliament in November.
The call addresses issues that are of key importance to the ESR, such as the harmonisation of training requirements for radiologists, eHealth and personalised medicine.
Besides 41 national radiological societies as well as all European radiological subspecialty societies, the members of the ESR Patient Advisory Group, the European Federation of Radiographer Societies (EFRS) and the European Federation of Organisations in Medical Physics (EFOMP) endorse the ESR call for a European Action Plan for Medical Imaging.
In order to ensure the ESR’s activities in the field are recognised at EU level and to implement concrete measures addressed, the ESR’s leadership held a number of meetings in Brussels in June with key stakeholders including representatives from the European Commission’s DG Health and Food Safety (SANTE), the European Parliament and Luxembourg, currently holding the Council presidency.
The ESR is confident that the fruitful discussions held in Brussels will increase the visibility of the profession’s key objectives and will positively affect the healthcare environment for the benefit of Europe’s patients.
HERCA multi-stakeholder meeting – ESR voluntary “self-commitments”
As part of the HERCA (Heads of the European Radiological protection Competent Authorities) multi-stakeholder approach to optimisation, the ESR submitted its voluntary “self-commitments” on the optimised use of CT scanners in July 2015.
The ESR “self-commitments” contain measures on diagnostic reference levels (DRLs), which comprise the ESR-led PiDRL tender project on paediatric DRLs, and a new initiative on clinical DRLs led by the ESR Radiation Protection Subcommittee. The latter project aims to develop DRLs for clinical indications in order to transform requirements in the BSS directive and recommendations from the ICRP (International Commission on Radiological Protection) into concrete action for users.
The survey series ‘Is your Imaging EuroSafe?’ is a further commitment, aiming to collect data on CT practices in order to create benchmarks for CT doses for specific clinical indications, and to allow for the future development of DRLs. To drive this process forward, the ESR aims to recruit around 50 imaging departments as ‘EuroSafe Imaging Stars’ that will serve as model institutions and champions of best practice in radiation protection.
As a result of discussions at the last HERCA multi-stakeholder meeting on April 1, the ESR has submitted an additional commitment on appropriate image quality. An ad hoc working group has been set up that brings together different stakeholders, including industry representatives, and a concept and methodology will be developed by September 2015.
To further develop the ESR’s approach to the upgrading of imaging equipment in Europe, which was set out in a paper published in 2014, the ESR is merging its Management in Radiology Subcommittee and its Economics Working Group into a new group that will be charged with developing a fully fledged equipment upgrade policy.