Department of Biological Standardisation OMCL Network & Healthcare (DBO)

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1 Department of Biological Standardisation OMCL Network & Healthcare (DBO) Implementation of Pathogen Reduction Technologies for Blood Components for Transfusion: Updated Table COUNCIL OF EUROPE European Committee (Partial Agreement) on blood (CD-P-TS) Study coordinators: Miguel LOZANO 1, Jean-Pierre CAZENAVE 2, Bernhard BRÄUNIG 3, Marie-Emmanuelle BEHR-GROSS 3 1. Hospital Clinic Provincial, Villarroel 170, Barcelona, Spain 2. Etablissement Français du Sang (EFS-Alsace), 10 rue Spielmann, BP 36, Strasbourg, France 3. European Directorate for the Quality of Medicines & HealthCare, Council of Europe, Strasbourg, France (Corresponding author: marie-emmanuelle.behr-gross@edqm.eu)

2 s Australia Pathogen reduction technology was not implemented in Australia in Universal leukocyte depletion was implemented in 2008 Austria 21,6% o p u 70,9% 7,2% Belgium 0% small perc. 96,57% 3, , ,3 0 Bosnia & Herzegovina Pathogen reduction technologies remain under review Bulgaria 65% 0% ,8% Canada Croatia 0% approx approx. 6% 0% 0 0 Cyprus Pathogen inactivated blood and blood components are not being manufactured or distributed by the Canadian blood establishments that supply all Canadian hospitals with blood and blood components intended for The Cyprus Blood Establishment does not perform plasma fractionation or manufacture medicinal products derived from human blood or plasma Czech. Rep 100% % experimentally 2

3 s Denmark 0% 0% 0% 0% 0% % 0% 0% Estonia 0% 0% 0% 0% 0% % 0% 0% 0% Finland 100% 0% 0% 0% % 0% 0% 0% France 0% 21,79% 64,72% 13, ,94% 0% Georgia 7,520 (2,820 of FFP for 3 months, 4,700 for 2 months) Plasma quarantine just in two blood facilities. In 2008, from approx. 32,000 of FFP prepared countrywide, 7520 have been Germany 94% 6% none none none ,07% none Greece (difficulties in logistics and stock management) 33,522 (satisfactory results - Coagulation factors losses within the accepted range - adverse reactions rate 1:2,177) A trial with pathogen reduction of 500 of apharesis platelets using the technology was planned to start at the end of 2009 Hungary Iceland 3

4 s Ireland 98,5% 100% Italy 3,9% 17% ,5% 0% Latvia 100% % Bact ALERT Lituania 93% % 2,7% Macedonia % Malta 30% % Moldova % Montenegro Netherlands 100% % New Zealand Norway 100% 0% 0% 0% % 0% 17% 0% Poland Portugal Romania 50% % for apharesis 10% for recovered 4

5 s litres* *Russian official BTS-statistic Russia litres* *Russian official BTS-statistic Serbia 2,26% ,2% 3,9% Slowak Rep. 70% % Slovenia ,57 68,45% Spain 35% 0 59% 5% 0% % Evaluation Sweden 2% % 12% Switzerland 91,8% 8,2% United Kingdom 0 19% 3% small number USA ,7% 2008 = not, opu = of plasma data from 2009 (2008 where specified) Data from

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