Blood Establishments (BEs) have faced, and will face in the years to come, a number of issues arising from recent developments, such as new regulations on medical devices, the globalisation of the supplier marketplace, and the changing scope of practice for health professionals in the field. BEs have also been faced with the major implications of the COVID-19 pandemic.
This virtual conference, a series of six webinars, will:
- provide participants with the latest information on each of the topics, as well as their state of play;
- discuss opportunities and risks in relation to changes and emerging issues; and
- provide expert opinions and recommendations on mitigating risks.
The aim was to draft recommendations that would support stakeholders and decision makers in the sector in developing strategies to overcome emerging issues and that could serve as a basis for future legislative and technical instruments.
Target audience
This virtual conference (webinars) is intended for blood sector professionals.
Webinar 1: The EDQM/Council of Europe and the EC - 10 years of co-operation in the field of blood transfusion
This webinar gives an overview of the accomplishments and successes of the EDQM/Council of Europe and the EC and the key achievements of 10 years of successful co-operation in this field.
Duration: 2 hours, 40 minutes.
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- 20 years of European Commission governance in the field of blood, by Andrzej Rys
- 60 years of Council of Europe governance in the field of blood, by Susanne Keitel
- 10 years of EC and EDQM co-operation in the field of blood, by Laurent Mallet
- EC & EDQM Collaboration: Towards the future in the Blood sector, by Marie-Laure Hecquet
- EC & EDQM Collaboration: Towards the future in other SoHO sectors, by Marta Lopez-Fraga
- Update on the evaluation of the EU blood legislation (and beyond), by Stefaan van der Spiegel
- Setting the Scene, by Marie-Laure Hecquet
Reading Materials
eBrochure : 10 years of co-operation between the European Commission and the EDQM
Webinar 2: The COVID-19 pandemic: Impact on the continuity of blood supply and lessons learnt
The COVID-19 pandemic is creating major disruption at all levels of healthcare services, including blood donations and supply. The second half of this webinar focuses on how BEs can ensure continuity of blood supply, maintain critical processes such as collection and transportation, and how they can rely on their Quality Management System (QMS) during the pandemic. It also shares the viewpoint of a regulatory/competent authority, their experience and lessons learnt during the outbreak.
Duration: 3 hours.
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- COVID-19 and the blood sector: Risks, response measures and developments, by Dragolslav Domanovic
- Competent authority viewpoint: Experience and lessons learnt, by Verena Plattner
- Blood Establishment Viewpoint: How to rely on the QMS during COVID-19, by Samantha Rowlands
- Blood Establishment Viewpoint: Maintaining critical processes in time of COVID-19 Focus on collection and transportation, by Jaap van den Blink and Francis Swaneveld
- The importance of ensuring business continuity for Blood Establishments, by Paul McKinney
Poster Presentations
- Effect of the pandemic on Blood supply in Hungary – K. Baroti-Toth, A. Matusovits, B. Jenei, S. Nagy
- The experience of a hospital blood bank during nationwide lockdown due to the COVID-19 pandemic – M. Skertsou, T. Dimoudi, A. Makri, I. Dendrinou, B. Tsangari, E. Tzini, N. Vgontza
- Contingency plan of a blood transfusion service during the SARS-CoV-2 pandemic – A. Argyroy, S. Nikolopoulou, M. Georgopoulou, C. Panagiotopoulou, A. Gafou
- Blood donation in Greece in the era of SARS-CoV-2 pandemic – S. Valsami, A. Argyrou, A.Pouliakis, M. Ganidou, S. Mellou, V. Papadopoulos, K. Stamoulis
Webinar 3: Globalisation of the supplier marketplace: State of play, opportunities and issues in the blood sector
This webinar provides an insight into the implementation of the EU procurement law in BEs and the challenges being faced by BEs in supply management and auditing of suppliers.
Duration: 3 hours.
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- Implementation of EU procurement law in Blood Establishment Quality Systems: Challenges and Issues, by Paul Behan
- Key challenges in supplies management, Blood Establishment’s perspective, by Alex Aquilina
- Challenges in auditing suppliers, Blood Establishment perspective, by Stéphane Bégué
- Business Continuity to ensure blood supply, viewpoint from a supplier, by Nigel Talboys
Reading Materials
Oral Testimonial
Webinar 4: New regulatory environment for medical devices: State of play, opportunities and issues in the blood sector
This webinar focuses on the impact of the new Medical Device (MD) and In Vitro Medical Device (IVD) Regulations on suppliers and their relations with BEs, on IT systems and in-house testing methods in BEs, as well as the reclassification of DEHP. The EDQM B-PTS Programme and considerations for Common Technical Specifications are also presented.
Duration: 3 hours.
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- Medical Device Regulation: Overview and Implementation, by Paul Piscoi
- Impact of MDR on the suppliers and their relations with Blood Establishments, by Pascale Van Hoydonck
- Impact of MD/IVD EU regulations on IT systems and in-house testing methods, by Ulrik Sprogøe
- Reclassification of DEHP: Impact on Blood Establishments, by Dirk de Korte
- Blood Proficiency Testing Scheme (B-PTS) Programme: Considerations for Common Technical Specifications (CTS), by Richard Forde
Poster Presentations
Webinar 5: Health professionals, changing scope of practice: State of play, opportunities and issues in the blood sector
The activities of healthcare professionals working in BEs, including nurses, physicians and pharmacists, are regulated by national and EU laws which define their scope of practice. However, in light of ongoing demographic changes, variations in the availability of personnel in certain professions and evolving competences and needs, there are growing demands to redeploy health professionals with a view to ensuring their efficient utilisation and safeguarding blood supply continuity. This session cover EU law governing the work of health professionals and share experiences as well as enablers and obstacles of the changing scope of practice for health professionals in BEs.
Duration: 2 hours, 26 minutes
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- Health professionals in the blood sector: State of play – Result from a focus, by Marie-Laure Hecquet
- EU law on healthcare professionals: the legal contexts for blood safety, by Tamara Hervey
- Change of scope of practice of healthcare professionals in Blood Establishment’s: The Austrian Experience, by Christof Jungbauer
- Trained senior nurses as first line consultants in blood donor eligibility matters: Operational process change in 2015, by Johanna Castrén
- Changing scope of practice: towards model approaches, by Craig Spalding
Oral Testimonial
Webinar 6: Working together to support blood establishments and ensure continuity of supply
Ensuring the continuity of blood supply, both donations (collection) and transfusion (demand), is a challenge for BEs. The last part of this webinar shares information on the various initiatives that have been launched, for example the EDQM/EC initiative on contingency planning, the initiatives that have been taken in the medical devices sector, and the supporting initiatives started by the European Centre for Disease Prevention and Control (ECDC), DG-REFORM, the European Commission and the EDQM/Council of Europe.
Duration: 2 hours, 30 minutes
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- Blood Supply Contingency and Emergency Plan (B-SCEP), by Richard Forde
- EU support mechanisms for the blood sector, by Stefaan van der Spiegel
- Technical support in health sector reform, by Maria Isabel Farfan Camacho
- EDQM supporting initiatives to help European Blood Establishments to have more resilient and sustainable blood systems, by Marie-Laure Hecquet
- Preliminary Conference Outcomes, by Richard Forde
- Concluding remarks: From HIV epidemic to COVID-19 pandemic, by Alex Aquilina
Poster Presentations
- Montenegrin experience with the EDQM B-PTS & B-QM Programmes, by Gordana Rasovic
- Cypriot experience with the EDQM B-PTS & B-QM Programmes, by Socrates Menelaou
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