Baxter Home
Conditions Therapies Products Services About Baxter
Training and Education Sustainability Contact Us
 

News Release

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:

 
Additional Statements:

Update on FDA Continuuing Investigation of Particulate Matter in Blood
 
Statement of American Red Cross Concerning Blood Quarantine

 

 

Media Contacts:

Tanya Tyska, 847-270-4918
Deborah Spak, 847-948-2349
Investor Contacts:
Neville Jeharajah, Baxter, 847-948-2875
Mary Kay Ladone, Baxter, 847-948-3371
 
 
 
Copyright & Legal Disclaimer  |  Privacy  |   Print this page