Publication of the 21st Edition of the EDQM Blood Guide

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has published the 21st edition of the Guide to the preparation, use and quality assurance of blood components (Blood Guide).

The Blood Guide is a compendium of generally accepted, harmonised European technical standards governing safety, efficacy and quality requirements for the manufacture, use and quality control of blood components in Europe and beyond. It is addressed to all professionals working with blood and blood components (from donation, collection and testing to processing, storage, distribution and transfusion), e.g. for blood establishments or hospital blood banks. It also addresses healthcare professionals and regulators in the blood sector. The Guide provides them with a comprehensive overview of recent advances in the blood sector and in the process of blood donation and collection.

This Guide also includes the Good Practice Guidelines (GPG), which set the standards for the implementation of quality systems in blood establishments and, where appropriate, hospital blood banks. According to the European Commission Directive (EU) 2016/1214, EU Member States should take the GPG into account when implementing quality systems in their blood establishments. On this occasion, Petra Doerr, EDQM Director, stated: "The new edition of the Blood Guide reflects the latest scientific knowledge, data and techniques. It will support the EDQM's objective of contributing to the provision of better healthcare for all. This is why we need to ensure that the Blood Guide standards are constantly updated in a transparent manner - and are based on the most advanced scientific rationale. Bearing in mind that much of the work on this edition was accomplished during the trying COVID-19 pandemic, we thank all the experts involved for their unfailing dedication and tireless efforts."

New in the 21st edition of the Blood Guide

The latest edition of the Blood Guide contains a number of improvements that make the revision process more transparent. For the first time, all changes from the previous edition are documented in a change log, accompanied by background documents explaining the scientific reasons for the changes. Both the change log and the background documents are published together with this 21st edition. The terminology used has been standardised, in particular harmonising the use of the terms "must" and "should", and consistent language has been introduced.

The scientific content of this edition is particularly noteworthy:

  • New and updated standards on data processing systems in CPCs 
  • Changes in donor selection criteria related to haemoglobin, iron stores, allergy and anaphylaxis, cancer and malignancies, interventions and treatments, acupuncture, tattoos, piercings and aesthetic medical procedures, surgical and dental treatment. 
  • In relation to plasmapheresis, the same allowable annual donation frequency as in the 20th edition, but a reduction in the recommended frequency for monitoring donor IgG levels 
  • The recommendation of glucose measurement instead of pH as a more appropriate quality indicator for platelets in additive solutions.

For more information, see the 21st edition of the "Guide to the preparation, Use and Quality Assurance of Blood Components (Blood Guide)".

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