This study aims at understanding the essential criteria needed to work as clinical/biomedical engineer in health facilities.

This study has been reviewed and given approval by the University of Warwick’s Biomedical and Scientific Research Ethics Committee (Ethical approval number REGO-2018-2283-AM01). Read the respondent leaflet here.

Start the Survey here.

Background: in order to ensure an equal level of safety and effectiveness for European patients, the European Parliament has published new regulations aiming at ruling the free circulation of medical devices among European countries. However, several other important aspects relevant for patient safety are not regulated. This is the case of minimum requirements to work as clinical engineers in European public hospitals or local Trusts. This survey is part of a wider study aiming at analyzing different requirements to work as a clinical engineer in different European countries.

Since 2015, Dr Pecchia has coordinated the collaboration among the European Alliance of Medical and Biological Engineering and Science (EAMBES) and the European Parliament through the establishment of the first European Parliament Interest Group on Biomedical Engineering (EPIG BME).

In the framework of this collaboration, the second EPIG BME meeting was organised in the European Parliament the 11th of October 2018. The final agenda is below and the relevant twits are available at https://goo.gl/VMVbMG 

This meeting brought together WHO representatives, ‘African, Caribbean and Pacific and European Union (ACP-EU) representatives and the most influential BME representatives form 4 continents (i.e., Europe, USA, Africa and Asia) via their scientific associations: the International Federation of Medical and Biomedical Engineering (IFMBE), International Organization for Medical Physics (IOMP) and their umbrella organization the International Union for Physical and Engineering Sciences in Medicine (IUPESM).

The topics discussed during the meeting where three:

· recognise BME as independent profession, by including BME as independent discipline in the ESCO database;

· to provide an independent space for research in biomedical engineering field creating a BME panel in the 3 European schemes for excellent science (e.g., ERC, FET and MSCA)

· establish stable collaboration with Africa Union in order to help them harmonizing their regulations on medical devices and medical locations among different African Courtiers and with the European one

The meeting was very well attended, with eminent and competent representatives from the European Parliament, European Commission, WHO and four Scientific Societies (EAMBES, IFMBE, IUPESM, IOMP).

· EPIG BME Parliamentary Members: Nicola Caputo (Italy, chair), Lara Comi (Italy, video), Neena Gill (UK, present), Lojze Peterle (Slovenia, not present, Peterle’s assistants), Marijana Petir (Croatia, present at the opening, Petir’ assistants stayed for all the meeting), Davor Škrlec (Croatia, present) and Cécile Kyenge (Italy, participated for 30min due to other commitments).

· European Commission Member: Bernd Rainer, DG Research (present).

· Speakers: Prof Panayiotis Kyriacou (UK, EAMBES President); Dr Umberto Bracale (Italy, Assistant Prof of Surgery at the University Federico II of Naples); Miss Tanja Valentin (Belgium, Director External Affairs, MedTech Europe); Prof Jari Hyttinen (Finland, EAMBES Fellow Chair); Dr Ashenafi Hussein (Ethiopia, IFMBE African Working Group on Biomedical Engineering); Miss Adriana Velazquez (Switzerland, Focal Point of Medical Devices at World Health Organization, WHO); Dr Leandro Pecchia (UK, University of Warwick and IUPESM Secretary General).

· Open discussion: moderators: Prof Shankar Krishnan (USA, IFMBE President); Prof Timo Jämsä (Finland, EAMBES Elected President), Prof Ratko Magjarevic (Croatia, IFMBE Elected President), Prof Marc Nyssen (Belgium, IFMBE Treasurer), Prof Slavik Tabakov (UK, IUPESM Past President), Prof Nicolas Pallikarakis (Greece, EAMBES), Dr Ernesto Iadanza (Italy, Chair IFMBE HTA Division), Prof Steven Keevil (UK, IUPESM), Mr Mariano Votta (Italy, Cittadinanzattiva), Dr Stefano Bergamasco (Italy, AIIC), Dr Antonella Belotti (Italy, Medical Doctor), Dr Carmelo De Maria (Italy, University of Pisa), Dr Peter Grainger (Irland, Naas General Hospital), Dr Magdalena Stoeva (Bulgaria, Medical University of Plovdiv), Dr Almir Badnjevic (Bosnia and Herzegovina, International BURCH University) and Dr Giuseppe Braghieri (Italy, Medical Doctor).

The ABSPIEH was represented by Dr Leandro Pecchia and Dr Rossana Castaldo.

Since 2015, the European Alliance of Medical and Biological Engineering and Science (EAMBES) started a stable collaboration with the European Institutions and in particular with the European Parliament through the establishment of the first European Parliament Interest Group on Biomedical Engineering (EPIG BME).

 EAMBES is advocating for an increased involvement of biomedical engineers (BMEs) in defining European regulations and forthcoming research frameworks.

The EAMBES, together with WHO and EPIG BME, have organized a new meeting in the European Parliament to discuss those topics (European Parliament, 11th of October 2018). The draft agenda is below and the latest will be available at https://goo.gl/VMVbMG

This event will bring the BME community inputs, thought the most influential BME representatives form 4 continents (i.e., Europe, USA, Africa and Asia) via their scientific associations: the International Federation of Medical and Biomedical Engineering (IFMBE), International Organization for Medical Physics (IOMP) and their umbrella organization the International Union for Physical and Engineering Sciences in Medicine (IUPESM).

The topics of the meeting will be two:

· How to maximally profit form the BME community inputs while design the forthcoming European framework for research (i.e., Horizon Europe)

· How to harmonise international regulation on medical devices and medical setting across these continents.

Five European Parliament Members will participate to the meeting, including Madame Neena Gill (S&D, West Midland representative at the Euro parliament for the Labour Party, UK), Lara Comi (EPP Vice-president from Italy) and Nicola Caputo (S&D, Italy), EPIG BME President.

From the European Commission, Mr Bernd Rainer (DG Research) will attend the meeting.

Ignatius Gomes, Secretary General of the “African, Caribbean, and Pacific Group of States Organization” will also participate to the meeting to discuss Africa-related BME topics.

The Warwick Biomedical Engineering (WEB) group, in the School of Engineering, is a proactive member of the EAMBES and had a key role in the organization of this event. Dr Leandro Pecchia, WEB member drafted the agenda as Chair of the EAMBES public affairs working group and General Secretary of the IUPESM.

The International Union for Physical and Engineering Sciences (IUPESM) is the umbrella organization for the International Organization for Medical Physics (IOMP) and International Federation of Medical and Biological Engineering (IFMBE). This union is regarded as the world scientific society for biomedical engineering and medical physics and federates more than 100 national societies from all the 6 continents, and the main transnational societies such as IEEE EMBSor EAMBES.

Each 3-years, the IUPESM organizes the World Congress on Medical Physics & Biomedical Engineering, which this year was in Prague (WC2018).

This was the first time that the University of Warwick was so well and successfullyrepresented in this important event!

Prof Tony Esty (Canda) wrote: "March 28th, 2018

Dear Leandro,

It is with great pleasure that the IFMBE/Clinical Engineering Division (http://cedglobal.org/) Awards Committee would like to inform you that your manuscript Health Technology Assessment of Medical Devices in Low and Middle Income Countries: study design and preliminary results, published in the Proceedings of the EMBEC & NBC 2017, was selected as a Best Manuscript for 2018. This award recognizes an individual or a group that published the best clinical engineering-related manuscript in IFMBE conferences proceedings and/or journals published in 2017. The main criteria for the award is that the publication must demonstrate innovation and research contributions by the author/s to the global clinical engineering and healthcare communities, and must help to improve patient outcomes through a combination of the following categories:

1.0 Originality and significant impact upon the clinical engineering field Original contribution to knowledge with an emphasis on the paper’s innovativeness in one or more of:

1.1 Global interest of subject matter

1.2 Patient safety

1.3 Best practices

2.0 Quality of arguments

2.1 Critical analysis of concepts, theories and findings

2.2 Consistency and coherency

2.3 Clear positioning of paper in existing international literature

3.0 Writing styleQuality of writing style in terms of:

3.1 Readability

3.2 Clarity

3.3 Organization of the article

The committee felt that your manuscript fully meets the above requirements.

Congratulations on receiving this award."