Skip Navigation LinksHome > Advocacy > Statements

Statement Before ACBSA on Support for a U.S. Hemovigilance/Biovigilance Program – 5/9/06

Statement of AABB before the Advisory Committee on Blood Safety and Availability

Presented by Barbee I. Whitaker, PhD

May 9, 2006
Support for a U.S. Hemovigilance/Biovigilance Program

AABB believes strongly that there is a clear need for a U.S. biovigilance program to capture and analyze data regarding infectious and non-infectious risks associated with receiving a blood transfusion or a tissue transplant.  Other countries, notably the United Kingdom, Canada and France, already have in place hemovigilance programs that provide policy makers and operational facilities with valuable data regarding transfusion risks.  Because the United States, unlike these other countries, does not have a national blood program and because the U.S. population is approximately five to ten times bigger than any of these other countries, we believe that any U.S. hemovigilance program must seek to coordinate and integrate the existing efforts, to reduce duplication, and must be a public/private initiative to ensure that the effort is sustainable.


AABB has presented to this committee on numerous occasions about the need to invest in the collection and analysis of data regarding a host of blood and transfusion safety issues.  Absent reliable data, policy decisions regarding transfusion safety will continue to be based on incomplete data and anecdotal evidence.  Today, we do not have fully reliable data in the United States about the relative risks of transfusion, whether the risk is an emerging infectious agent or a non-infectious serious hazard of transfusion.  For example, it is widely believed that current data underestimate the magnitude of noninfectious risks of transfusion.  These underestimates are due in part to the fact that current data on noninfectious hazards are derived from passive reporting systems rather than the prospective, active investigation of blood components transfused into patients.  A study involving three major teaching hospitals in Belgium concluded that current, passive reporting systems underestimate the true frequency of serious hazards of transfusion by 30-fold.  Even fatal transfusion mishaps are subject to “significant underreporting.”  Despite the established occurrence of fatal transfusion-associated graft versus host disease (TA-GVHD), there were no TA-GVHD fatalities reported to FDA from 1976 to 1985.  As the government and private sector continue to face budget constraints, the Advisory Committee, HHS and blood organizations will need good, reliable data to prioritize corrective measures to mitigate transfusion risks


The AABB has long identified the development of a national hemovigilance system as a priority.  The AABB 2006-2007 strategic plan identifies the development of a broader biovigilance system as one of the primary objectives for the association.  As a practical matter, however, the AABB alone cannot implement a comprehensive national hemovigilance or biovigilance program.  AABB, however, believes that it can serve a critical role in the development and implementation of this system.  AABB has a demonstrated track record in bringing organizations and their interests together towards a common goal. Same examples are the Bacterial Contamination Task Force, the West Nile Virus Task Force, the AABB Inter-Organizational Task Force on Domestic Disasters and Acts of Terrorism, and the Nationwide Blood Collection and Utilization Survey.


On June 1, AABB is initiating a pilot project to collect needed early warning data regarding the threat of transfusion-transmitted West Nile virus.  With our unique perspective representing virtually all of the nation’s blood collection facilities, including community blood centers, the American Red Cross facilities and the hospital transfusion services responsible for transfusing most of the blood in the United States and our substantial experience in data collection – including several editions of the Nationwide Blood Collection and Utilization Survey – AABB is well-suited to collect and analyze such data.  AABB is prepared to establish an inter-organizational task force and work with other interested parties, including HHS and international organizations that have many years experience in managing hemovigilance networks, to expand this project to collect and analyze data regarding other infectious, as well as noninfectious, risks of transfusion. 


In the future, our larger goal is to expand such a hemovigilance program to a biovigilance program that will include data on tissues and cellular products, including hematopoietic stem cells.  Our efforts in helping hospital blood banks managing tissue inventory in compliance with JCAHO and AABB standards, will put us in an excellent position to accomplish this endeavor.


AABB strongly believes that the private sector transfusion medicine community needs to work closely with the government in advancing our common goal of collecting and analyzing data regarding transfusion risks that will be used to improve patient care.  We respectfully urge the Advisory Committee and Department of Health and Human Services to support the concept of a joint public/private initiative that brings the best of both sectors to address this urgent need.