The European Union has adopted new rules on the quality and safety of blood and blood derivatives, such as plasma, used in medical treatment. The rules will apply from the beginning of September next year and will make more comprehensive the EU-wide requirements and standards introduced by the original legislation two years ago.
Traceability rules cover identification, recording, and labelling requirements. They establish a verification procedure for issuing blood and blood components, introduce the concept of annual reporting, and set out measures for recording traceability.
Every medical facility handling blood products will have to operate a system registering the donations they have received. This will also indicate whether the donations were processed locally or not and confirm whether they were used for transfusions, discarded, or returned to the original blood distribution establishment. The records will have to be kept for at least 30 years.
A notification system will enable national governments and the European Commission to draw lessons from any adverse incidents within the EU, even if these do not require any tracing of the defective products.
The measures are designed to ensure that every unit of blood can be tracked from the original donor to its final destination, whether this be a recipient or a manufacturer of medicinal products.
The second set of rules lays down quality standards and specifications for establishments, apart from hospital blood banks, that are responsible for collecting, testing, processing, storing and distributing human blood or blood components.
The legislation addresses issues such as staff qualifications, requirements for premises and areas where blood is handled, eligibility of donors, laboratory testing, processing and validation, and labelling. Its provisions also cover inspection and auditing and procedures for complaints and potential recall of blood batches.
Commenting on the twin measures, Markos Kyprianou, the EU health commissioner, said: “Healthcare staff and patients need to be confident the blood they are using is safe. Having common safety standards and safety systems across the EU helps facilitate cooperation between healthcare systems by enabling them to import blood from each other. It also helps give Europeans confidence that wherever they receive treatment in Europe, they will be properly protected from bloodborne diseases.”
Under the 2003 EU legislation day to day quality control of blood and regulation of the organisations that collect, process, or store it are managed nationally and regionally. However, the European Commission can adopt measures for implementation to ensure common Europe-wide standards, after consulting with national officials and blood safety experts.