EDQM Publishes 22nd Edition of the Blood Guide
Summary
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has published the 22nd edition of its Blood Guide. This updated guide includes revisions to haemovigilance, new chapters on topical blood components and emergency planning, and updated donor selection criteria.
What changed
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has released the 22nd edition of its comprehensive Blood Guide, a key technical reference for blood donation and transfusion practices. This edition introduces significant updates, including a revised Haemovigilance chapter, two new chapters on "Blood components for topical use or injection" and "Blood supply contingency and emergency planning," and revised donor selection criteria addressing aspects like Creutzfeldt–Jakob disease, malaria, and donor age. The guide aims to reflect the state of the art and support ethical practices in blood donation.
This updated guide is intended for healthcare professionals, regulators, and policymakers involved in blood donation and transfusion. While it is a non-binding technical reference, its comprehensive nature and detailed change log are designed to facilitate the adoption of harmonised European standards for safety, efficacy, and quality. Regulated entities should review the updated guidance to ensure their practices align with the latest recommendations, particularly concerning donor selection and emergency preparedness. The EDQM encourages the uptake of these updated standards to enhance patient and donor safety.
What to do next
- Review the 22nd edition of the Blood Guide for updated technical standards and recommendations.
- Incorporate revised donor selection criteria into relevant protocols.
- Familiarize staff with new chapters on topical blood components and emergency planning.
Source document (simplified)
1 / 2 21 May 2025, Strasbourg, France EDQM publishes 22nd edition of the Blood Guide The European Directorate for the Quality of Medicines & HealthCare (EDQM) of the Council of Europe has published the 22nd edition of the Guide to the preparation, use and quality assurance of blood components (Blood Guide). This comprehensive guide continues to serve as an essential technical reference for healthcare professionals, regulators, policy makers and all those involved in blood donation and transfusion. This edition marks a major milestone in the EDQM’s strategic efforts to address current and emerging public health challenges and priorities, supporting the design and implementation of the best possible donation and transfusion procedures for the benefit of patients and donors alike. It not only reflects the state of the art but also underscores the EDQM’s commitment to ethical practices and the non- remunerated donation of substances of human origin. This new edition, updated over the last two years, includes a complete review of all chapters, an in-depth revision of the Haemovigilance chapter and the addition of two new chapters, Blood components for topical use or injection and Blood supply contingency and emergency planning. Other significant changes relate to donor selection criteria (Creutzfeldt–Jakob disease, malaria, blood pressure and pulse, plasmapheresis, iron stores, donor age and insulin), along with the standardisation of terminology. All changes are documented in a change log to facilitate uptake of the new edition and are supported by background documents detailing the scientific rationale behind them. Betina Sørensen, Chair of the ad hoc Working Group on the Blood Guide (GTS), stated: “I am proud to present this 22nd Edition of the Blood Guide, which reflects our collective commitment to harmonised, European standards that provide safety, efficacy and quality requirements covering all aspects of much-needed blood components in Europe and beyond. This new edition showcases international collaboration, leveraging expertise from a dedicated working group of top professionals from Council of Europe member states and observers. It reflects the commitment to scientific excellence and trust, ensuring that all actors across the blood sector have access to the most recent advances and technical standards.” Petra Doerr, Director of the EDQM, added: “This new edition of the Blood Guide underscores our ongoing dedication to supporting the highest standards in blood transfusion practices. This guide is a testament to decades of rigorous scientific work and international co-operation, ensuring that healthcare professionals have easy access to the latest and most reliable information.” Download or order the Blood Guide The Blood Guide is available in English, in both print and electronic formats, and will soon be published in French. It can be downloaded from FreePub, the EDQM’s free publications platform, or purchased from the EDQM WebStore. For more details, visit the EDQM website: https://go.edqm.eu/BTg. Contact: Evangelos Tasopoulos, Communications and Events Division, EDQM, Council of Europe Tel.: +33 (0)3 90 21 53 90 – E-mail: evangelos.tasopoulos@edqm.eu
2 / 2 Note for the Editor: Further information is available on the internet site www.edqm.eu. The European Directorate for the Quality of Medicines and HealthCare (EDQM) is a structural part of the Council of Europe. It traces its origins in the statute to the Convention on the Elaboration of a European Pharmacopoeia, opened for signature in 1964. Today, 39 member states of the Council of Europe have ratified the convention and more than 30 countries from all over the world participate in the EDQM activities as observers. The EDQM promotes and protects human and animal health by developing standards and supporting their implementation. It is active in four major policy areas: medicines, pharmaceutical care, substances of human origin and consumer health. EDQM staff represent almost 30 different nationalities, and its work is supported by a network of nearly 2 000 experts from all over the world. An international organisation set up in 1949, the Council of Europe works to promote democracy, human rights and the rule of law continent-wide. It also develops common responses to social, cultural and legal challenges in its 46 member states.
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