Risk assessment of HTLV-I/II transmission by tissue/cell transplantation : Part 2: Risks by tissue type, impact of processing and effectiveness of prevention measures

An important part of ECDC's function is to provide its stakeholders with scientific advice upon their request. On 2 August 2010, ECDC received such a request from the European Commission's Directorate-General for Health and Consumers (DG SANCO) - Directorate C Public Health and Risk Assessment. ECDC was asked to assess the epidemiological history of Human T-lymphotropic Virus (HTLV), possible risks of HTLV transmission through transplantation of human tissues and cells, and the possible measures to prevent such transmission, in particular with regard to tissues and cells imported from the United States. Testing for HTLV-I/II infection among most tissue and cell donors was recently discontinued in the US. In the European Union, testing for HTLV-I is required for tissues and cells donors living in, or originating from high incidence areas, or with sexual partners originating from those areas, or where the donor's parents originate from those areas. In accordance with its internal procedures for providing scientific advice, ECDC addressed the question by setting up an ad hoc expert group of internal and external experts in the field. The expert group was set up in cooperation with the EU Commission's DG SANCO (Directorate C Public Health and Risk Assessment)and the EU Competent Authorities for Tissues and Cells. However, in accordance with its internal procedures, ECDC selected experts based on their individual scientific and professional qualifications. After receiving clarifications on specific questions from the Commission, ECDC performed a literature review to capture all evidence available. The expert group then reviewed the scientific evidence, assessing its validity and generalisability in relation to the question asked. ECDC is presenting the results of its assessment in two separate technical reports (Parts 1 and 2), of which this is the second part. This report addresses the potential risk of HTLV transmission through transplantation of human tissues and cells and possible measures to prevent such transmission, in particular in relation to tissues and cells imported from the United States.