Effect of legal regulations on the use of fresh arterial homografts

摘要

abstract_textpRegulated by the German Transplant Act from 1997 the use of fresh arterial homografts was a routine procedure. In 2007 the Tissue Act came into place and since then the further use of fresh homografts was no longer supported by the appropriate regulatory authorities./ppThe current legal regulations were analyzed for the possibility of further use of fresh arterial homografts/ppThe manufacture and transplantation of homografts is regulated by the Pharmaceutical Act. A key prerequisite of this regulation is a final microbial examination according to Pharmacopoeia. As a consequence the manufacture and supply with fresh arterial homografts lacking a microbial monitoring was not accepted by the regulatory authorities. The exemption from the regulation in the context of individual treatment trial is excluded due to legal interpretations./ppThe effects of the "Tissue Law" on the use of fresh arterial homografts are disappointing. Despite the good results of fresh homograft applications further use in Germany is currently not possible./p/abstract_text