Statement of the American Red Cross Concerning Blood Quarantine

WASHINGTON, February 13, 2003 — The American Red Cross has received further testing results from the Centers for Disease Control and Prevention (CDC) regarding the white particulate matter recently noticed in blood bags. The results are as follows:

The CDC evaluated a limited number of chemicals related to the manufacture of polyvinyl chloride plastic, which is used in blood collection bags. Polyvinyl chloride-related chemicals were selected as markers for possible production differences in the affected and unaffected bags. Tests were conducted on unused blood collection bags from both affected and unaffected lots manufactured by Baxter Healthcare. Although there was some variation from bag to bag, no substantial differences were found in the levels of these chemicals when bags from affected and unaffected lots were compared. These results do not provide further information on the nature or cause of the particles observed in the blood collection bags.

As has been previously reported, CDC’s tests for biothreat agents were negative; routine bacterial, viral and fungal cultures are also negative to date.

The Red Cross continues to work in cooperation with the Food and Drug Administration (FDA), the CDC, the blood bag manufacturer and others in assessing the current situation. Studies to date by the American Red Cross and others continue to reveal particulate material that is composed of normal blood components. Studies have not identified a cause. Testing to date by the CDC has not found evidence of infectious agents.

The Red Cross continues to utilize our national distribution system to ensure blood is available for patients in need. Additionally, we are continuing to rigorously inspect each unit collected to help ensure its safety.

Further information may be found on the FDA website: http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01199.html and media inquiries can be directed to the FDA press office at 301-827-6242.

Media Inquiries on CDC testing results can be directed to the CDC press office at 404-639-3286.




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