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Do facilities plan to request an exception to allow 5 day storage of pooled platelets?

The Editors would like to know which facilities plan to request an exception to be allowed to utilize pooled platelets that can be stored for 5 days after pooling, now that the CFR permits it. See Exceptions and Alternative Procedures Approved Under 21 CFR 640.120 (updated Nov. 28, 2006), which includes:

23. 21 CFR 640.24(a)

* Allow storage for up to 5 days of Platelets prepared from Whole Blood that are leukocyte reduced and pooled prior to storage, provided the platelets are pooled and stored in a set approved for this use and the pooled platelets are tested for bacterial contamination.

Please submit comments to the e-Network Forum.

Ira A. Shulman, MD
CBBS e-Network Forum Editor & Moderator

W. Tait Stevens, MD
CBBS e-Network Forum Assistant Editor & Moderator
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Posted:Nov. 30, 2006

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