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News Details
News Date: 07 February 2005
News Title: BBTS response to Draft Health and Safety Legislation
News Group: BBTS
News Story: British Blood Transfusion Society Response to Draft Health and Safety Legislation on The Blood Safety and Quality Regulations 2005

The above legislation is based on the Directive 2002/98/EC of the European Parliament and of the council of 27th January 2003; and of the Commission Directive 2004/33/EC of 22nd March 2004.

This is an extract from the BBTS response. You can download the full response from the members resources section

The Blood Transfusion ‘Industry’ in all Developed Countries has become increasingly complex. In order to achieve the standards of quality and safety appropriate and required of the modern age, a high degree of professionalism and care has to be reached and maintained by well trained multidisciplinary staff work forces in Blood Centre and in Clinical settings. As the Society represents a wide cross-section of all the health care professionals involved in the whole transfusion process (from ‘vein to vein’) its voice on all matters to do with transfusion theory and practice is uniquely placed within those of all health practitioners.

The Directives of the European Union in relation to Blood Transfusion are timely and broadly appropriate. The Society welcomes them and applauds their intentions, which are to maximise patient welfare and safety within the margins of a cost effective service provision. However, there is no doubt that full implementation of the Draft legislation as it stands would be extremely difficult and of dubious cost-efficacy. This is principally because although standard blood products can be defined relatively clearly and consistently, particularly as ‘outputs’ or ‘products’ of a manufacturing Blood Centre (‘Blood Establishment’), the definition of their final preparation and use in clinical settings is more difficult and, moreover, beyond the clinical ‘control’ of the manufacturing sector.

Biological factors have an inevitable and profound influence on the quality and standard of Blood Products. The ‘raw materials’ (the donors) have an inherent variability which does not compare, for example, with the raw materials (specific chemicals) required for the manufacture of drugs. This variability – most pronounced in genetic factors such as blood groups – is also evinced in ‘intra-donor’ variables; for example, blood taken on one occasion from one donor will differ from the blood collected at the next donation. Nevertheless, it is vital that any blood product for transfusion is safe, effective and needed.

This is an extract from the BBTS response. You can download the full response from the members resources section
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