Quality & safety of substances of human origin
Blood transfusion
The EDQM’s blood transfusion activities aim to ensure the safety, quality and optimal use of blood and blood components, with a direct focus on protecting both donors and recipients. By promoting the principles of voluntary and non-remunerated donation, mutual assistance and the responsible use of blood products, the EDQM helps improve public health outcomes and reduce wastage of these critical resources.
Overseen by the European Committee on Blood Transfusion (CD-P-TS), these activities address ethical, legal and organisational aspects of blood transfusion, generating reports and guidance aimed at maintaining safe, effective and equitable systems. By gathering international data, monitoring practices across Europe and facilitating knowledge sharing among experts, the EDQM fosters collaboration and continuous improvement in this vital area of healthcare.
Work programme
Blood Guide
The CD-P-TS is responsible for the regular review and update of technical standards for blood and blood components and the Good Practice Guidelines (GPG) included in the Guide for the preparation, use and quality assurance of blood components (Blood Guide), in accordance with Recommendation No. R (95) 15 on the preparation, use and quality assurance of blood components. All Council of Europe Committee of Ministers recommendations and resolutions related to blood transfusion are available at https://go.edqm.eu/BloodTexts.
The 22nd edition of the Blood Guide was adopted by the CD-P-TS in November 2024, with publication scheduled for spring 2025. As a sign of the EDQM’s commitment to extending its global outreach, a French edition of the Blood Guide is also planned. This considerable undertaking will bring the guide’s benchmark standards to an even greater professional audience.
Highlights of the 22nd edition include:
- changes in donor selection criteria related to variant Creutzfeldt–Jakob Disease (vCJD), malaria, blood pressure and pulse, donor age, iron stores, insulin and plasmapheresis;
- a complete revision of the haemovigilance chapter;
- new chapters on blood components for topical use or injection and on blood supply contingency and emergency planning (B-SCEP).
As with the previous edition, all changes are documented in a change log, accompanied by background documents detailing the scientific rationale behind the changes to standards. Both the change log and background documents are published alongside this edition.
The transition to a modern online platform for future editions has also begun. To better meet the needs of public consultation and the publication of guidelines, an advanced, interactive online format is being designed. One important feature will be ease of access during consultations and its daily use in clinical practice. The new platform will have a direct connection with the European Commission substances of human origin (SoHO) platform (currently under development), allowing users to interact with content hosted there. The EDQM and the EC SoHO publication platforms should be linked by Q2 2027, before the new EU SoHO regulation comes into force.
Data collection and monitoring of practices
The CD-P-TS publishes annual activity reports on the donation, collection, testing, use and quality aspects of blood and blood components. Each report provides comprehensive activity data from the CD-P-TS member states and highlights new or changed practices, addressing trends in the blood sector in Europe.
In 2024, work continued on a comprehensive report detailing the trends and observations on the collection, testing and use of blood and blood components in Europe over the period 2020-2023. This report, scheduled for publication in 2025, aims to inform strategic developments and policy making in the European blood sector.
Simultaneously, progress was made on developing an up-to-date mapping of the blood components prepared and used across Europe. This work, presented under the title “Towards removal of non-leucocyte depleted blood components from European standards”, was highlighted through an abstract and poster presentation at the International Society of Blood Transfusion (ISBT) Congress in June 2024 and will serve as a vital resource for understanding current practices and addressing emerging needs. Its insights will play a key role in shaping the strategic revision of the blood component monographs in the Blood Guide.
Risk behaviours with an impact on blood donor management and transfusion safety
A dedicated working group of the CD-P-TS is responsible for the continuous collection of data on the incidence and prevalence of sexually transmitted infections that might impact the safety of transfusions, as required by Resolution CM/Res(2013)3 on sexual behaviours of blood donors that have an impact on transfusion safety.
In 2024, progress was made on compiling a compendium of deferral policies across Council of Europe member states concerning sexual behaviours and blood donor selection. This critical topic, presented under the theme “Sexual Behaviours and Blood Donor Selection in Europe – A Changing Landscape”, was highlighted through an abstract and poster presentation at the ISBT Congress in June 2024. The findings from this work offer valuable insights to enhance blood donation policies and strengthen transfusion safety practices across Europe.
Blood supply continuity
The CD-P-TS continues to lead efforts to support blood supply continuity throughout Europe, playing a pivotal role in co-ordinating and collaborating with stakeholders to drive the exchange and implementation of best practices.
In 2024, the CD-P-TS advanced initiatives to enhance military–civilian co-operation and contributed to a broader strategy to develop comprehensive contingency and emergency guidelines, addressing ongoing challenges and key needs to strengthen the resilience and sustainability of blood supplies in Europe.
A key focus was the incorporation of the Blood Supply Contingency and Emergency Plan (B-SCEP) into the 22nd edition of the Blood Guide. This includes comprehensive recommendations for establishing, implementing and maintaining a B-SCEP and specific recommendations for member states, blood establishments and hospital blood banks. The inclusion of B-SCEP standards and supporting guidance in the Blood Guide is crucial to facilitate contingency arrangements and backup systems for blood supply, with the aim of safeguarding continuity.
Plasma supply continuity
The CD-P-TS also continues to conduct activities to help strengthen the implementation of measures to promote and support safe plasma donation and donor protection, and to ensure continued and safe access for patients to plasma-derived medicinal products (PDMPs) for life-saving treatments. This includes the continual revision of standards relating to the safe donation and collection of plasma for fractionation in the Blood Guide, data collection and reporting on the trends in plasma supply in Europe, supporting the co-ordination of meetings on the use of PDMPs and rare disease treatment, and supporting plasma collection-targeted activities.
The CD-P-TS plays an important co-ordinating role in supporting the exchange and implementation of good practices, facilitating communication and collaboration among stakeholders. It provides support for research and development efforts on safe plasma donation, optimising the plasma supply chain and efforts towards achieving and maintaining a sustainable supply of plasma and PDMPs.
In 2024, the CD-P-TS continued its efforts to advance the Anti-D immunoglobulin (IgG) project, exploring ways to contribute to the increase of anti-D plasma donations by starting or restarting collection programmes across Europe. The CD-P-TS also held a plasma supply continuity stakeholder event in March 2025 with an agenda focusing on the latest developments in plasma supply across Europe, including strategies to improve and increase the safe collection and sufficient supply of plasma and PDMPs.
Blood PTS and Blood QM Programmes
The EDQM continued to run the Blood Proficiency Testing Scheme (B-PTS) and Blood Quality Management (B-QM) Programmes to support blood establishments (BEs) in implementing the EU blood legislation and the standards laid out in the Blood Guide and the GPG. Both programmes have been co-funded by the European Commission and the EDQM since 2010.
The external assessment of the testing capability of European BEs also continued in 2024. Seven B‑PTS studies were organised, with an average of 69 laboratories participating in each. A new type of study for the bacterial testing of platelet components was developed and added to the B-PTS portfolio in 2024 after a successful pilot phase in 2023. In order to avoid any bias, it should be noted that the calculation of the average number of participants does not take into account the study on bacterial testing of platelet components, as this was the first full-fledged study of this kind. Additionally, bacterial testing is not performed routinely in all European BEs.
In 2024, the B-QM Programme was run fully on-site. Nine assessment schemes were organised; six were performed on-site following cancellations due to unforeseen circumstances (changes in BE management, etc.). One scheme was rescheduled for 2025. No virtual training on Quality Management was foreseen in 2024.
The EDQM worked to organise a conference entitled “Innovation in Blood Establishment Processes”, a two-day, in-person event in Strasbourg held on 14 and 15 January 2025.
