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DEERFIELD, Ill. -- While extensive tests conducted by the Food and Drug Administration (FDA) as well as Baxter Healthcare Corporation have found no association between containers used in the collection of blood and recent observations of aggregate formations containing natural blood elements, Baxter announced today that it would sponsor and support further study of factors potentially contributing to these observations.
Dr. Jeffrey McCullough, MD, director of the Biomedical Engineering Institute at the University of Minnesota, will lead the expert panel, which will include blood banking and transfusion medicine specialists from across the country. A final report of the panel's findings and recommendations for the industry is anticipated in approximately four to six weeks.
"While extensive tests have not shown an association with any manufacturer's blood pack unit and the recent observations of aggregate formations of blood elements, we recognize there still are outstanding questions regarding the cause," said Greg Young, corporate vice president and president of Baxter's transfusion therapies business. "We are pleased to sponsor a panel of distinguished experts, led by Dr. McCullough, to advance understanding among the blood banking industry of the phenomenon that has been observed and how to respond."
In addition to Dr. McCullough, who has more than 30 years experience in transfusion medicine, the panel will include:
-- Roger Dodd, PhD, executive director for Biomedical Safety, American
Red Cross, Holland Labs
-- Ronald Gilcher, MD, president, chief executive officer and medical
director of the Oklahoma Blood Institute
-- Scott Murphy, MD, chief medical officer, American Red Cross Blood
Services, Penn-Jersey Region
-- Merlyn Sayers, MB, BCh, PhD, president and chief executive
officer of Carter BloodCare in Texas
"The safety and availability of the blood supply is of critical importance to all of us involved in transfusion medicine. The objective of the expert panel will be to advance greater understanding across the blood banking community of factors contributing to recent observations of aggregation in red blood cells and to provide recommendations for the industry in responding to and preventing such occurrences," said McCullough.
The FDA announced in a statement last week that all analyses to date of possible infectious agents, chemical contaminants, or blood bag defects have found no abnormalities that indicate a public health risk. They also noted that many of the particles observed recently in blood and blood components may be explained by the use of certain standard, accepted procedures for preparation of red blood cells for transfusion. In addition, the American Red Cross last week announced the ending of the voluntary quarantine of certain units of leukoreduced red blood cells following extensive tests identifying the observed particulate matter to contain normal elements of blood with no noticeable increased incidence of patient adverse reactions.
Aggregate formation of naturally occurring blood elements is not an unusual observation in collected blood. It is for this reason that filters are used in the transfusion or administration of blood and blood components into patients, and that blood and blood components must be carefully collected, processed and transfused under carefully controlled and defined conditions.
Baxter Healthcare Corporation is the principal domestic operating subsidiary of Baxter International Inc., which, through its subsidiaries, assists healthcare professionals and their patients with treatment of complex medical conditions including cancer, hemophilia, immune disorders, kidney disease and trauma.
Source: Baxter Healthcare Corporation