›FDA, Department of Health and Human Services, CDC, and American Red Cross have Safety of Donated Blood on the Agenda Sept. 10-12
September 3, 2008 (BUSINESS WIRE) MEDIA ADVISORY
WHAT:
Officials from the U.S. Food and Drug Administration Blood Products Advisory Committee (BPAC) will meet with government institutions and top experts from academia and private industry on September 10, 11 and 12 in two separate meetings to address issues related to safety of the blood supply including:
• Bacterial contamination of donated blood products for transfusion, which can lead to sepsis (Sept. 10)
• Risk of infectious disease such as malaria from blood donors traveling abroad, and impact on donor pool and blood shortages (Sept. 11)
• Emerging concerns of U.S. diseases spread by ticks like babesiosis and lyme disease (Sept. 12)
WHY:
All of these organizations are committed to ensuring the safety of the nation's blood supply. Recent fines against the American Red Cross have shed public light on concerns around contaminants in the blood supply and areas for improving blood product safety. For example:
• 125 blood transfusion related fatalities were reported to the FDA in 2005 and 2006
• 1 in 3,000 units of platelet blood components are believed to be bacterially contaminated at time of transfusion putting 1 in 500 patients at risk for sepsis (based on an average of 6 units of platelets per transfusion)
• West Nile Virus took four years to identify and arguably more than 3,200 people were infected through blood transfusion
• FDA reported a total of five deaths related to transfusion-transmitted babesiosis in 2006 and 2007
The FDA BPAC and Department of Health and Human Services Advisory Committee on Blood Safety and Availability (ACBSA) have previously met to discuss strategies to improve blood safety, including pathogen inactivation, a proactive approach to eradicate bacteria, viruses and pathogens from the blood supply.
HOW:
Pathogen inactivation technologies have the ability to inactivate bacteria, viruses and parasites from donated blood that may not be detected by current diagnostic tests. Many European countries are currently using pathogen inactivation to safeguard their blood supply.
WHO:
Speakers will include representatives from the American Red Cross, Centers for Disease Control, academic and industry experts.
Dr. Jeff McCullough, M.D., American Red Cross Professor, Transfusion Medicine, Professor, Laboratory Medicine & Pathology, University of Minnesota
Dr. Larry Corash, M.D., Chief Medical Officer, Cerus Corporation
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