New guidelines for the preparation of blood and blood components and for the use of blood components (Hemotherapy) - Alterations, interpretations andcommentary (Part 2)

Since July 2000, the new regulations of the production of blood and blood c omponents and of the application of blood products (hemotherapy) edited by the German Federal Chamber of Physicians (Bundesarztekammer, BAK) and the G erman Federal Agency for Sera and Vaccines (Paul-Ehrlich-Institut, PEI) are effective. With this second part of an article which is published in two s ubsequent issues of INFUSION THERAPY AND TRANSFUSION MEDICINE, the main cha nges regarding the use of blood products (chapter 4) compared to the regula tions of 1996 are presented, interpreted, and commented upon. Major changes in this chapter of the regulations 2000 concern storage and transport of b lood components at the user side, duration of validity and frequency of ant ibody screening and cross-matches, direct antiglobulin test in all newborns , investigation of adverse reactions with special attention to those caused by bacterial contamination of blood products, and detailed instructions fo r an extensive quality assurance system including monitoring of the efficac y of hemotherapy. The establishment of these demands certainly means a cons iderable personal and financial effort for the clinical facilities. On the other hand, a lot of these changes seems not to be sufficiently based on ne w scientific knowledge or experience. Therefore, a broad public and compete nt discussion of these regulations is necessary. It is the explicit aim of this article to initiate this discussion.