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Project TS057: Risk Behaviours having an impact on Blood Donor Management and Transfusion Safety
Recommendation by the European Committee on Blood Transfusion (CD-P-TS)
Exclusion criteria for blood donors, especially with regard to sexual behaviours, are much debated. The present situation, involving the permanent exclusion of individuals whose behaviour places them at higher risks of acquiring severe infectious diseases that are transmissible by blood, is being questioned by citizens and by the press in terms of whether this kind of donor deferral is rightful, appropriate, efficient and required.
Despite the testing of blood donations with highly sensitive test systems, there remains a residual risk of transfusion-transmitted infection due to donations given in the 'window' period i.e. the time period between infection and detectability of the infection. This is not always recognised by the public.
As a consequence, the CD-P-TS of the EDQM, Council of Europe has appointed a working group (TS057) to monitor current practices, evaluate scientific data and define a harmonised approach to establishing rules for donor deferral, linked to the risks attributable to sexual behaviour (1). The group started its work in February 2010 and will finish during autumn 2011.
The working group has performed a common European evaluation of donor selection criteria according to Resolution 2008 (5) of the Committee of Ministers of the Council of Europe. Preparation of the technical memorandum outlining the results of the study is now complete. A draft Resolution with further recommendations for such evaluations will be submitted to the Committee of Ministers for adoption following consultation of the Bioethics Steering Committee of the Council of Europe.
The preliminary findings of the working group re-emphasise that adherence to deferral rules is crucial for blood safety. Standardised donor questionnaires and donor education are needed to increase adherence to deferral rules. Also standardised collection of data throughout Europe needs to be performed for monitoring epidemiology and adherence since, at present, the available data do not allow a decision to move away from the donor deferral rules currently being applied in relation to sexual behaviours.
Therefore, the CD-P-TS presently recommends to Member States not change donor selection criteria for the collection of blood components neither for collection of blood components for transfusion nor for the preparation of medicinal products before the current study has been completed.
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Additional Information & Documentation
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NEW: Technical Memorandum (PA/PH/TS (11) 28 R)
UPDATED: Terms of Reference of the Working Group (PA/PH/TS (09) 28 3 R)
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