Why ‘Safer than Ever’ May Not Be Quite Safe Enough

Abstract

Although the blood supply in developed countries is now very safe, residual microbial risks can still be identified. These are mainly due to bacteria. A wide range of sophisticated (and resource-consuming) interventions are in place which are generally successful in dealing with the risk from known viral agents. However, newly emergent viral risks can usually only be addressed after they have been shown to transmit and after tests have been developed. Parasitic and, even more significantly, bacterial risks (especially in platelet preparations which have to be stored at 22 °C) have often not been managed as effectively as the risk for the ‘known’ viruses such as HIV, HBV and HCV. Pathogen inactivation (PI) offers an approach to remove the vast majority of microbial risks. In the future, if the full inventory of transfusable components can be effectively pathogen-inactivated, PI could form an alternative basis for blood safety in terms of microbial risk, rather than just another incremental safety intervention.

Efficacy and Safety of the New Intravenous Immunoglobulin IGIV 10% in Adults with Chronic Idiopathic Thrombocytopenic Purpura

“…However, this approach has been singularly effective in managing agents traditionally considered to pose the highest risk to the patient [4]. As plasma remains predisposed to contamination by a variety of blood-borne pathogens including new or re-emerging infectious agents [1][2][3]7], transfusion specialists and regulatory agencies are now focusing a similar degree of attention on emerging infections with a view to balancing the need for both the safety of the blood supply and the availability of lifesaving blood and blood products [3,4]. The new 10% liquid immunoglobulin preparation, IGIV 10% (KIOVIG, Baxter International Inc., Deerfield, IL, USA), was developed to provide a preparation with an increased margin of safety.…”

Targeting DNA and RNA in Pathogens: Mode of Action of Amotosalen HCl

“…Current testing methods detect only specific viruses, using antibodies, antigens or viral genome sequences. This specificity leaves gaps in the blood safety net that are open to rare pathogens not currently tested as well as opportunistic DNA-and RNA-based pathogens that may enter the blood banking system in the future [1]. Amotosalen HCl (S-59) (see fig.…”

Concerning Caspari et al: Pathogen Inactivation of Cellular Blood Products – More Security for the Patient or Less? Transfus Med Hemother 2003;30:261–263

“…Current blood safety standards are high in the context of the residual risk per donation for selected blood-borne viruses for which sensitive tests have been introduced (HIV, HCV, and HBV). A pan-European view of the residual cumulative risk for HIV, HCV, and HBV across different countries suggests that the cumulative residual risk per blood donation ranges from 1:86,505 to 1:249,750 [3]. Since patients who require labile blood components frequently receive multiple transfusions during a course of therapy, the residual risk should reflect the patient's risk for a course of therapy, rather than the risk per single donation.…”