This addendum to the Seventh edition contains revisions of Chapters 21, 22, 23 and 24 that take account of the relevant EU Directives* and resulting UK Regulations.
The advice in these printed Guidelines is believed to represent acceptable practice at the time of printing. It is policy to revise these Guidelines as new developments occur. However, it may not be possible to do so at the time of such change and the Guidelines should therefore be used with due regard to current acceptable practice.
As and when it becomes necessary to make further changes to these guidelines, these will published on the website www.transfusionguidelines.org.uk. Notifications of such changes are also sent to the management of each of the four UK Blood Services, to the British Association of Tissue Banks, British Society of Blood and Marrow Transplantation, and the Health Protection Agency.
In accordance with the Directives, any changes in donor selection criteria that are necessitated by new information about the epidemiology of infections are also notified to the Medicines and Healthcare products Regulatory Agency (MHRA) and to other institutions with Blood Establishment status.
I wish to thank the members of the Standing Advisory Committees who undertook the task of revising or writing the relevant chapters. In particular we wish to thank Caroline Smith for her painstaking preparation of the material for this publication.
* Directive 2006/17/EC of 8 February 2006 'implementing Directive 2004/23/EC of the European Parliament and of the Council as regards certain technical requirements for the donation, procurement and testing of human tissues and cells'. OJ, 9.2.2006
Directive 2006/86/EC of 24 October 2006 'implementing Directive 2004/23/EC of the European Parliament and of the Council as regards traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells'. OJ, 25.10.2006
Professional Director, Joint UKBTS/NIBSC Professional Advisory Committee
Scottish National Blood Transfusion Service
Protein Fractionation Centre
Ellen's Glen Road