Q. You mentioned a little section about blood products can also be returned to useable inventory provided they have not been outside of a controlled environment for more than the time recommended by the manufacturer. The standard (14.6.2) says the product must be maintained within the “parameters” described in the product monograph. I’m thinking parameters probably also includes temperature as well. As in, if a vial of WinRho was issued out of the lab and came back greater than 8 degrees, it cannot be returned to useable inventory. Your thoughts?
A. Interesting that you comment on the blood products – that specific section was actually added in conjunction with ORBCON. The parameters would also include temperature. For certain products, we have sought additional information from the manufacturers (outside of the product monograph) on product stability so that has helped us extend some products even longer.
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