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BAXTER
PROVIDES GRANT TO BLOOD BANKING AND TRANSFUSION MEDICINE EXPERTS TO ADVANCE
AWARENESS OF FACTORS CONTRIBUTING TO RECENT OBSERVATIONS OF AGGREGATION
IN COLLECTED BLOOD
Extensive Tests
Find No Association Between Blood Collection Containers and Aggregate
Formations Containing Natural Blood Elements
DEERFIELD, Ill., March
5, 2003 -- While extensive tests conducted by the U.S. 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, M.D., 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, Ph.D.,
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,
M.B., B.Ch., Ph.D., 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 Dr. 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. (NYSE: BAX). Baxter International Inc., through
its subsidiaries, assists health-care professionals and their patients
with treatment of complex medical conditions, including cancer, hemophilia,
immune disorders, kidney disease and trauma. The company applies its expertise
in medical devices, pharmaceuticals and biotechnology to make a meaningful
difference in patients' lives.
FOR ADDITIONAL
INFORMATION:
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