2.1 Background

Previous EU Initiatives

In 1999 the European Commission published the report “Blood safety in the European Community: an initiative for optimal use”, the outcome of a symposium held in Wildbad Kreuth, Germany. (Download from the bottom of this page.) The following paragraphs are from this report, referred to elsewhere in the text as the EU 1999 Optimal Use Initiative:

“…Considerable attention has been given to ensuring that the material collected and the processes adhered to in the preparation and distribution of (blood) products are as safe as possible. While attention has also been given to the therapeutic use … through guidelines, consensus conferences etc, there is increasing evidence that the results have been less than satisfactory and as a consequence over-use, under-use and inappropriate use of blood products persists. This can contribute to increased risks for patients and the waste of resources.”

“Transfusion of blood … involves numerous steps … which need to be strictly controlled to ensure the safety of patients and to prevent (avoidable) adverse events. These steps can be related to:

The patient, including assessment of physical condition and the need for blood under emergency or non emergency conditions; verification of identity; informed consent to the transfusion and taking a blood sample for pretransfusion testing.

The (blood) product, including reserving products in the transfusion service; identification of the assigned unit; delivery to the clinical ward and management of used and unused blood products.

The product and the patient, including identification before transfusion, administration to the patient, and documentation of outcomes.

“…Every effort should be made to establish a quality management system … in the clinical part of the blood transfusion chain.”

These points were reiterated at a second Wildbad Kreuth symposium in May 2009 on “The Optimal Clinical Use of Blood Components: Quality and Best Practices in Haemotherapy”, at which participants noted that despite many developments since 1999, concerns persist about the safety and effectiveness of blood component transfusions.

The European Commission SANGUIS study showed wide variations in surgical blood use in 43 European Hospitals during 1989-90. More recent audits have continued to show variations. Such variations in practice are an indicator of clinical uncertainty in prescribing. There were similar findings in a recent Austrian survey

Wildbad Kreuth Report 1999 PDF1.22 MB