Upping the Ante on Safety: Hemovigilance and Biovigilance Programs

By Laura Fusco

You may have heard the term “biovigilance” more often in the past few years, as this concept has just recently caught on in the United States. Biovigilance and hemovigilance are systems designed to help improve the health and lives of patients by systematically collecting, analyzing and reporting on the outcomes of collection and transfusion and/or transplantation of blood components and derivatives, cells, tissues and organs. Such data can provide the basis for continuous process improvements and evidence-based standards setting.  

Europe Leads the Way

Recognizing the need for this type of systematic data program, the government of France passed a law in 1993 that established the world’s first hemovigilance system. The British followed in 1996 by developing the Serious Hazards of Transfusion network based on the French system. “Other countries saw the value of having this type of system, and now every developed country in the world except the U.S. has a hemovigilance network,” explains James AuBuchon, MD, FCAP, FRCP(Edin), a moderator and faculty member for Monday afternoon’s session on hemovigilance.

Although Canada and Europe set the standard for hemovigilance systems, the United States is quickly coming into its own, with several biovigilance initiatives already under way, including the Medical Error Reporting System for Transfusion Medicine and the Transplantation Transmission Sentinel Network system. The West Nile Virus Biovigilance Network and the Chagas’ Biovigilance Network are two AABB initiatives that are already yielding results. Through AABB’s Interorganizational Task Force on Biovigilance, formed in 2006, the larger community of transfusion medicine and cellular therapy professionals is now working on a nationwide biovigilance network, with the near-term objective of initiating a national hemovigilance system some time next year.

“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 noninfectious risk of transfusion,” said Barbee Whitaker, PhD, director of AABB’s Center for Data and Special Programs. “But the potential is great for information systems to enhance biovigilance, which is a primary objective of the AABB strategic plan.” 

Three Sessions Address Progress

Whitaker, who serves as moderator of Sunday morning’s session, 5237-QE “Current Topics in Biovigilance,” explained that the session will review recent developments in U.S. biovigilance and address how hospital transfusion services and blood centers can prepare for the implementation of hemovigilance systems based on national and international experiences. This session will also bring attendees up to date with the current state of hemovigilance in Canada, and discuss how other countries can benefit from that country’s experience.

Monday’s session, 5325-TC “Hemovigilance,” will explore the focus, design and mechanisms of four biovigilance and hemovigilance systems around the globe, comparing the organizational and governing structures of each. Faculty members also will describe the advantages and disadvantages of each program’s design with respect to quality of data.

Coverage of these patient safety systems continues Tuesday evening with an industry workshop presented by Cerus Europe BV. “The Role of Hemovigilance in the Introduction of New Blood Safety Technologies” will delve into the mechanisms of transfusion safety. Speakers will cover the impact of hemovigilance programs on blood collection and processing and address how analysis of transfusion outcomes data helps measure the way technologies effectively reduce bacterial contamination or inactive pathogens.

Collectively, these three sessions provide an overview of the latest developments in biovigilance and hemovigilance and serve as way to bring together leaders in the community for continued discussions on how best to advance patient safety.


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