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The FDA web site clarifies that intraoperative blood
reinfused in surgery or recovery is exempt from the labeling
requirement. 
Does anyone know if they extend that to the patient room, or
does the labeling requirement take effect once the patient
leaves the recovery room? Most of our patients are reinfused
after returning to their room after leaving recovery.
Paul

Paul J. Goedicke, CLT(HHS)
Administrative Laboratory Director
Fort Madison Community Hospital
5445 Avenue O
Fort Madison, IA 52627-0174
(319) 376-2023 (voice)
(319) 376-2413 (fax)
[EMAIL PROTECTED]

Re:
I received information today that autologous blood collected
during surgery at our hospital (i.e., intraoperative
collections) must meet the FDA ruling that requires
barcoding of all blood and blood components. And that this
rule takes effect on 4/26. We haven’t even begun the ISBT
barcoding project for our ARC products, as our ARC region
has not begun the process.
Marlene Smith, MT
[EMAIL PROTECTED]
 


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