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First Ever National Biovigilance Network in the U.S. Reaches $1 Million in Funding, Prepares for Fall Pilot Launch
Date:7/16/2008

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"This has the potential to be a significant advancement, benefiting both patients and donors," said Ron K. Labrum, President and CEO of Fenwal Inc. "By standardizing and validating comprehensive information on the safety of transfusion medicine, biovigilance can provide a critical early-warning system that benefits patients and helps focus health-care innovators on those issues most critical to improving health-care outcomes."

The first stage of the pilot phase will be implemented with nine hospitals across the country. This phase will allow for fine-tuning of the surveillance system and analysis of initial data collected. Additional organizations are voluntarily registering to contribute data, with full participation and system launch anticipated in 2009.

The U.S. is the only developed nation that does not have a national system to track and monitor the safety of blood collection and transfusion. To date, the U.S. has relied on information from hemovigilance systems in other countries and on tracking by individual hospitals, transfusing organizations and blood centers. The challenge is that these results are not widely shared and common conclusions cannot be drawn. This results in the loss of an opportunity to learn from adverse events that may happen in more than one place and reduces the likelihood that the events can be prevented elsewhere. By contrast, those countries with surveillance systems have lower morbidity and mortality rates for patients and donors.

Hospitals, blood centers and other facilities will use the U.S. Biovigilance Network to report adverse events and unexpected reactions and incidents related to transfusion medicine. Analysis of this data will lead to process improvements which may lead to new standards of quality and safety for the collection, testing, processing, storage, distribution and transfusion of blood and use of related biological therapies. It will also allow for the design of interventions that can
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