by fiods-ifbdo | Gen 22, 2016 | News |
Blood and Plasma Regulations – Towards a revision of the EU Blood Directive: What is needed in a new Directive / Should Plasma be included in the Blood directive ? KEY STRATEGIC AREAS PLUS Consensus Conference 2016 Intercontinental Hotel, Estoril Portugal 14-15 January 2016 Key strategic areas/topics • Increasing plasma collection in the European Union to ensure the availability of PDMPs – Maximize use of recovered plasma – Increased use of plasmapheresis • Need to focus on availability of treatments for patients Key strategic areas/topics New scope? Quality, safety and supply Need for better clarification between blood collection/labile blood products and plasma collection/PDMPs Need for clear and precise definitions: – Blood – Bloodcomponents – Plasma – Plasmafortransfusion – Plasma for further manufacturing – Voluntary, voluntary unpaid, self-sufficiency, sufficiency, compensation, remuneration Key strategic areas/topics Perspectives of patients, healthcare professionals, donors should be pro-actively considered in drafting the directive Involvement of all key stakeholders in drafting the directive Implications of directive for movement of plasma internationally (for internal consideration) Key strategic areas/topics Patient and donor health & safety Need to update technical directives EU Blood Directive and Plasma IFBDO view-point IFBDO/FIODS The EU Directives covers patient and donor safety related to components and products from human blood– Including plasma whether it is recovered or source When the source material is human blood, thereis always a donor behind – No donors means no plasma We remain dependant on donors to secure blood components and products to treat and improve the life of patients, and there must be an obligation not to harm the donors IFBDO/FIODS • The Donors main...
