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

21st edition of Guide to the preparation, use and quality assurance of blood components

21st edition of Guide to the preparation, use and quality assurance of blood components

The Guide to the preparation, use and quality assurance of blood components (“the Blood Guide”) is a compendium of widely accepted, harmonised, European standards that provide safety, efficacy and quality requirements for the preparation, use and quality control of blood components in Europe and beyond. Updated regularly, as a technical appendix to Council of Europe Recommendation No. R(95)15 the Blood Guide collates the most current scientific information available to provide a comprehensive overview of the most recent advances and technical standards in the blood sector.

The Blood Guide also provides guiding principles to be considered for the donation of blood and blood components and includes the Good Practice Guidelines (GPG) which provide standards for the implementation of quality systems in blood establishments and, where applicable, hospital blood banks. In accordance with European Commission Directive (EU) 2016/1214, the GPG should be taken into account by EU member states in the implementation of quality systems in blood establishments.

The Blood Guide is elaborated by a dedicated working group (the GTS) composed of internationally recognised experts. The GTS works under the aegis of the European Committee on Blood Transfusion (CD-P-TS) the steering committee responsible for blood transfusion activities at the Council of Europe.

The Blood Guide is intended for all professionals working in the donation, collection, testing, processing, storage, distribution and transfusion of blood and blood components, for blood establishments, hospital blood banks and healthcare and regulatory professionals in the blood sector.

 

What is new in the 21st Edition?
 

The latest edition of the Blood Guide introduces a number of improvements to the revision process. For the first time, all changes with respect to the previous edition have been documented in a change log, accompanied by background documents detailing the scientific rationale behind them. Both the change log and background documents are published alongside this 21st edition.

The terminology has been standardised, harmonising in particular the use of the terms “must” and “should” in the guide, and inclusive language has been introduced.

Highlights of this edition include:

  • New and updated standards on data-processing systems in the GPG
  • Changes in donor selection criteria where related to:
    • haemoglobin
    • iron stores
    • allergies and anaphylaxis
    • cancer and malignancies
    • interventions and treatments
    • acupuncture, tattooing, body piercing, and aesthetic medical procedures
    • surgery
    • dental treatment
  • With regard to plasmapheresis, the same permitted annual donation frequency as in the 20th Edition, but a reduction in the recommended frequency for monitoring of donor IgG levels.
  • The recommendation of glucose measurement as a more appropriate quality indicator than pH for platelets in additive solutions
  •  
Download :

https://freepub.edqm.eu/publications/AUTOPUB_48/detail

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    1. Sherif Abd El Monem

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