179 Vox Sanguinis (2007) 93, 179–182 RAPID COMMUNICATION © 2007 Blackwell Publishing Ltd No claim to original US government works DOI: 10.1111/j.1423-0410.2007.00937.x Blackwell Publishing Ltd Pathogen inactivation: making decisions about new technologies – preliminary report of a consensus conference H. G. Klein, 1 D. Anderson, 2 M.-J. Bernardi, 3 R. Cable, 4 W. Carey, 5 J. S. Hoch, 6 N. Robitaille, 7 M. L. A. Sivilotti 8 & F. Smaill 9 1 Department of Transfusion Medicine, Clinical Center, National Institutes of Health, Bethesda, MD, USA 2 QE II Health Sciences Centre, Halifax, Nova Scotia, Canada 3 CRIR – Centre de Recherche Interdisciplinaire en Réadaptation, Montreal, Quebec, Canada 4 American Red Cross Blood Services, Farmington, CT, USA 5 Owen Sound, Ontario, Canada 6 St. Michael’s Hospital, Toronto, Ontario, Canada 7 CHU St. Justine, Montreal, Quebec, Canada 8 Queen’s University, Kingston, Ontario, Canada 9 McMaster University Health Sciences, Hamilton, Ontario, Canada Key words: blood transfusion, pathogen reduction. Received: 20 April 2007, accepted 24 April 2007, published online 16 May 2007 Methods to inactivate pathogens, used extensively in the manufacture of plasma protein fractions, have all but eliminated transmission of infection by these products [1]. Technologies for reducing the risk of infection from single-donor blood components are not as well-established and have not been as enthusiastically embraced. None of these methods has been adopted in North America. Reasons for slow acceptance include: (i) the current safety of the volunteer blood supply, (ii) absence of any single method to treat whole blood or all components, (iii) the success of surveillance and screening test development in dealing with emerging pathogens, (iv) the inability of current technologies to inactivate some agents such as certain small, non-encapsulated viruses, spores, and prions, (v) concerns regarding remote risks from the residual chemical agents used during the pathogen inactivation (PI) process, and (vi) the perceived lack of cost- effectiveness of these technologies compared to strategies to reduce non-infectious risks of transfusion [2]. The Canadian Blood Services and Héma-Québec organized a consensus conference in March 2007 to provide recommendations and guide decision-making in this area. An independent panel of nine health professionals and members of the public answered predetermined questions based on a literature review and on experts’ presentations of the scientific evidence in an open forum. The Panel’s draft statement was read in its entirety to the experts and the audience for comment. The statement was then finalized by the Panel within a few weeks of the conference. The questions and conclusions are summarized below. 1. Is the current risk of transfusion- transmitted diseases acceptable in relation to other risks of transfusions? Dramatic advances in the safety of allogeneic blood trans- fusion have been made during the last quarter of a century. At present, the estimated residual risk of transmission through transfusion of human immunodeficiency virus (HIV), hepa- titis C virus (HCV), hepatitis B virus (HBV), and human T-cell lymphotropic virus (HTLV) in Canada is, respectively, 1 in 7·8 million donations, 1 in 2·3 million donations, 1 in 153 000 donations, and 1 in 4·3 million donations [3]. The risk of bacterial contamination has been reported as high as 1 in 2000 platelet transfusions (active surveillance in the USA) prior to the implementation of bacterial testing of platelets and bacterial sepsis has occurred on the order of 1 in 41 000 Correspondence: Harvey G. Klein, MD, Department of Transfusion Medicine, Clinical Center, National Institutes of Health, Bethesda, MD 20892, USA E-mail: hklein@dtm.cc.nih.gov