Safe Blood is Critical to Improving Patient Outcomes.
But the continued risk of transfusion-transmitted infections (TTI) from bacteria and emerging pathogens, as well as blood shortages, have brought global attention to the importance of blood safety and availability.1-11
In fact, FDA has made clear through guidance that standard aerobic primary culture alone is insufficient to protect the platelet supply, and have called for new measures to minimize risk of bacterial contamination.1
INTERCEPT BLOOD SYSTEM
Effective in reducing the risk of transfusion-transmitted infections (TTI),12 pathogen reduction for platelet components provides a solution to blood centers and hospital clients that ultimately benefits patients who need it most.
Not only does pathogen reduction comply with FDA’s pending guidance on addressing bacterial contamination,1 it reduces risk beyond bacteria with mitigation of TTI due to viruses and parasites, as well as TA-GVHD due to T-Cells.12
Cerus Forms Group to Research Optimal Production of COVID-19 Convalescent Plasma
Addressing Bacterial Contamination – FDA Issues Final Guidance
*Certain non-enveloped viruses (e.g., HAV, HEV, B19, and poliovirus) and Bacillus cereus spores have demonstrated resistance to the INTERCEPT process.
1. Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion: Guidance for Industry, December 2020. 2.Kleinman S et al. Transfusion 2013;53:1603-1618. 3. Stramer SL, Hollinger FB, et al. Transfusion 2009;49(Suppl 2):1S-29S. 4. Rasongles P, et al. Transfusion 2009;49:1083-91. 5. Succo T et al. Euro Surveill. 2016 May 26;21(21). 6. Gjenero-Margan I et al. Euro Surveill. 2010 Sep 2;15(35). 7. Danis K et al. Euro Surveill. 2011 Aug 25;16(34). 8. Barzon L et al. Euro Surveill. 2009 Aug 6;14(31). 9. Schmidt M et al. Transfus Med Hemother 2014;41:10-17. 10. “FDA. Revised Recommendations for Reducing the Risk of Zika Virus Transmission by Blood and Blood Components. FDA Guidance for Industry July 2018. 11. ABC News; “The Nation Has a Major Blood Shortage,” September 19, 2018. 12. The INTERCEPT Blood System for Platelets Package Insert, Cerus Corporation; May 28, 2019.