TraQ Program of the PBCO
 
 


EU Blood Directive 

TraQ Backgrounder

by Pat Letendre

First posted 2 April 2004; Last updated: 22 Jan. 2010

Background. Being curious about why an EU directive that came out in 2002 and was amended in January 2003 merited a special meeting of the BBTS and IBMS in June 2004, I contacted a UK colleague. Dave Doolan and Chris Elliot of Leeds Teaching Hospitals kindly provided the basis for the UK overview below. Also included are updates that have happened since.

In a nutshell, EU directives have become UK law through the Blood Safety and Quality Regulations 2005 (Statutory Instrument 2005/50 and Statutory Instrument 2005/1098). See New Regulations Implementation.

Related resources

Overview of some of the issues in the UK

Relevance to Canada

Overview of some of the issues in the UK

Initially many people thought that this legislation was to be directed at the national blood services of each country. In the UK, the NBS is already highly regulated, coming under the MHRA - Medicines and Healthcare Regulatory Agency,  which ensures that the production, quality, storage, security, etc., of the NBS is up to the stringent standards applied to the pharmaceutical industry.

Now there is concern that the  legislation will apply to hospital sites and have a serious impact. The latest time that the directive can be incorporated into each countries' legal framework is Feb. 8, 2005 and from incorporation there is a period of 9 months grace. Therefore,  the latest deadline for implementation is Nov. 2005. 

Key areas for hospital laboratories include

  • Article 10 - covers adequate ongoing staff training and makes CPD mandatory (already in place in UK)
  • Article 11 - requires formal quality systems to be in place
  • Article 12 - requires secure document control
  • Article 14 - requires vein to vein tracebility
  • Article 15 - incident reporting - could make SHOT participation in the UK mandatory
  • Article 21 - will set standards for storage, transport & distribution
  • Article 23 - data protection legislation (already in place in UK)

The June meeting will clarify the impact of applicable articles in the EU Directive on UK hospital transfusion services.

Update (August 2005): The final report to the Department of Health prepared by the NHS Operational Impact Group (OIG) recognised that some activities currently undertaken in hospital transfusion laboratories might potentially be classified as "processing" under the new Blood Safety and Quality Regulations. The MHRA have confirmed that the activities (listed below) can only be carried out by licensed Blood Establishments after the 8 Nov. 2005:

  • Pooling of cryoprecipitate
  • Irradiation of blood components
  • Manipulation of hematocrit for neonatal transfusion
  • Splitting of components
  • Washed red cells

There are many more implications, including financial. See the

Relevance to Canada

In Canada a similar situation has occurred regarding CAN/CSA-Z902 (Blood and Blood Components), scheduled to be published in April 2004. For several years Canadian transfusion services have been planning how they will meet the impending new regulations. As background documents see

Initiatives

Just a few of the initiatives related to development of quality systems and increased blood safety in Canadian transfusion services:

Related Resources 

 

 

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