title: Interpretive conundrum on the exclusion criterion of "transplantation with xenografts" for tissue and cell donation.
abstract: In the context of the EU Directives for human tissues and cells (2004/23/EC, 2006/17/EC and 2006/86/EC) further interest has arisen on the practical application of a few clauses. One such aspect, for the evaluation phase of a potential donor, is the interpretation of the exclusion criterion "transplantation with xenografts." This article outlines the consensus viewpoints regarding the earlier evaluation of the risks related to xenotransplantation and describes the current status of the terminology and recommendations/laws in several healthcare sectors. The application of uniform terminology is encouraged within the healthcare sectors at the international level.
authors.affiliation: Danish Medicines Agency, Axel Heides Gade 1, 2300, Copenhagen S, Denmark. mic@dkma.dk
authors.forename: Michael A
authors.initials: MA
authors.lastname: Cox
authors.forename: Scott A
authors.initials: SA
authors.lastname: Brubaker
mesh_terms: D000818:Animals; D001803:Blood Transfusion; D046148:Donor Selection; D004864:Equipment and Supplies; D006801:Humans; D014019:Tissue Donors; D014183:Transplantation, Heterologous