Role of CE in a changing healthcare . Perspectives of Mediterranean countries

1. Role of CE in a changing healthcare. Perspectives of Mediterranean countries AlmirBadnjevic, Stefano Bergamasco, LejlaGurbeta, Paolo Lago, Lorenzo Leogrande, Mario Medvedec, Nicolas Pallikarakis, Christophe Parret, Dusan Perovic, LedinaPicari, Jose Domingo Sanmartin Fourth WHO Global Forum on Medical Devices

2. Background • Thanks to IFMBE and the Clinical Engineering Division we have many new opportunities to collaborate and share experiences across Clinical engineers worldwide • International events take place regularly (e.g. the ICEHTMC: Hangzhou 2015, Sao Paulo 2017, Rome 2019) • Local meetings can be arranged to share experiences and common issues for specific geographical areas • European countries share a common legal framework (EU Directives on Medical Devices and Health Technology Assessment) that is becoming increasingly uniform with the new EU Regulations on MDs and IVDs Fourth WHO Global Forum on Medical Devices

3. The event: I Forum of Clinical Engineering in the Mediterranean • The I Forum of Clinical Engineering (CE) in the Mediterranean took place in Bari, Italy the 13th of September 2018. • The event was organized by the Italian Clinical Engineers Association with the support of the Clinical Engineering Division (CED) of the International Federation for Medical and Biological Engineering (IFMBE). • It gathered together representatives from 8 Mediterranean countries, either European Union (EU) members or candidate EU members Fourth WHO Global Forum on Medical Devices

4. The event: I Forum of Clinical Engineering in the Mediterranean Participants: Spain France Italy Croatia Bosnia and Herzegovina Montenegro Albania Greece Fourth WHO Global Forum on Medical Devices

5. The event: I Forum of Clinical Engineering in the Mediterranean • Jose Domingo Sanmartin - Sociedad Espanola de Electromedicina e IngenieriaClinica (SEEIC), Spain • Christophe Parret - Association Francaise des IngenieursBiomedicaux (AFIB), France • Paolo Lago, Stefano Bergamasco, Lorenzo Leogrande - AssociazioneItalianaIngegneriClinici (AIIC), Italy • Mario Medvedec - Croatian Biomedical Engineering and Medical Physics Society (CROBEMPS), Croatia • LejlaGurbeta, AlmirBadnjevic - Bosnia and Herzegovina Medical and Biological Engineering Society (DMBIUBIH), Bosnia and Herzegovina • Dusan Perovic - Clinical Centre of Montenegro, Montenegro • LedinaPicari – Ministry of Health, Albania • Nicolas Pallikarakis - Hellenic Society of Biomedical Technology (ELEVIT), Greece Fourth WHO Global Forum on Medical Devices

6. The event: I Forum of Clinical Engineering in the Mediterranean Left to right: Christophe Parret, Paolo Lago, LedinaPicari, Lorenzo Leogrande, Stefano Bergamasco, Mario Medvedec, LejlaGurbeta, Dusan Perovic, Nicolas Pallikarakis Fourth WHO Global Forum on Medical Devices

7. The Final Statement for the Global Clinical Engineering Day, 21st October 2018 A “Final statement” was prepared following the discussion during the Forum With the occasion of the Global Clinical Engineering Day, 21st October 2018, the participants want to share with the global clinical engineering community, the healthcare authorities and the public the following points that emerged as the most important for effective and safe health technology management. Fourth WHO Global Forum on Medical Devices

8. The Final Statement Medical technology is reshaping the way health care is delivered but is at the same time becoming more complex and extremely diverse. Therefore, it requires special skills to create, deploy, regulate, assess, manage, use and maintain it, to provide quality, safety and efficiency for the benefit of patients and society in our different countries. Comprehensive knowledge and application of the regulations for market surveillance and vigilance, as well as the use of Health Technology Assessment and Health Technology Management Systems becomes more critical than ever. The role of Clinical engineering is worldwide recognized as essential in order to cope successfully with these developments and the forthcoming challenges. Fourth WHO Global Forum on Medical Devices

9. The Final Statement (cont.) The World Health Organization (WHO) initiative to identify an international classification, coding and nomenclature system of Medical Devices (ICMD), freely available and appropriately maintained, is of high importance. Nomenclature is the basis of a correct medical device (MD) inventory and essential for the Computerised Maintenance Management Systems, used today in all developed countries. It is also indispensable for an effective vigilance, pre- and post- market surveillance, as well as for Health Technology Assessment. Fourth WHO Global Forum on Medical Devices

10. The Final Statement (cont.) The new EU regulations on Medical Devices 745/2017 and 746/2017 will be fully enforced in the next couple of years (May 2020 and May 2022 respectively), and all parties involved, amongst them clinical engineers, must get ready to apply them effectively. This will require dissemination of knowledge on these novel aspects, training, etc. However, many practical aspects of these regulations must still be defined by the EU commission with further acts (e.g. the MD nomenclature, UDI system, Eudamed database, single use MD reprocessing rules, etc.). The Clinical engineering professionals are very concerned about whether all these aspects will be ready and well defined in time, to avoid having "grey areas" that may lead to different and uncertain applications across countries, with different situations in terms of health technology manufacturing, post-market surveillance, management, and assessment. Cross-country collaboration will be very useful to share experiences, best practices and promote common approaches. Fourth WHO Global Forum on Medical Devices

11. The Final Statement (cont.) Clinical engineers are key health professionals for patient care quality, safety and efficiency, and in European countries must have career paths fully regulated and contained in the European Commission Database of Regulated Professions, with career opportunities (internship, university (post)graduate specialist study, specialization/residency, sub-specialization, lifelong learning/continuing professional development) just like other health professionals with educational level 6-8. The recent effort led by the WHO to complete a global survey on the number of clinical and biomedical engineering practitioners (more than 800.000 worldwide) is extremely important for the recognition of the profession by the ILO (International Labour Organization) as a distinct and well-defined category. Additionally, the initiative of the European Alliance of Medical and Biological Engineering (EAMBES) that led to the creation of a European Parliament Interest Group - EPIG- on Biomedical Engineering, is highly recognised as a very significant step towards the recognition of the important role of biomedical/clinical engineering in healthcare today. Fourth WHO Global Forum on Medical Devices

12. The Final Statement (cont.) In order to provide high quality, safety and efficiency of health services, it is necessary to define clinical/biomedical engineering staffing needs in healthcare facilities based on well-defined criteria: • Number and type of medical devices • Medical procedures • Patients • Hospital departments and personnel • Hours of users training and continuing professional development • Population • Number of beds • etc. Fourth WHO Global Forum on Medical Devices

13. The Final Statement (cont.) Following WHO resolutions and the recent publication of the WHO Atlas on Medical Devices, we urge European countries to involve much more clinical and biomedical engineers in activities regarding: • National policies on health technology • Regulatory agencies • National health technology assessment units • National health technology management units • Notified Bodies • Medical device nomenclature systems • Introduction of medical devices into the legal metrology for establishing traceability of measurements • Medical device incorporation • Inventory and maintenance in health facilities • etc. Fourth WHO Global Forum on Medical Devices

14. Collaboration and … team building Fourth WHO Global Forum on Medical Devices

15. Disclosure The presenter declares no conflict of interest with the materials provided. Thank you very much on behalf of Stefano Bergamasco (who prepared this presentation) and the whole team Fourth WHO Global Forum on Medical Devices