[Barcoded label for split or pooled products]

We are currently trying to meet the machine readable label requirement with a DYMO label printer. The user will have to manually enter the unit# into a stand-alone program that will allow us to print on-demand unit number barcode labels. We already have ABO/RH, facility id, product code barcode labels that we purchase. We are really close.

Cliff, thank you for including the Federal Register link here. I was unaware that the FDA established an "effective" date for the barcode labeling requirement 21 CFR 606.121.©(13)(iii) already on April 26, 2004. I'm assuming the deadline of April 26, 2006 that AABB established for the machine readable label requirement in Association Bulletin #06-03 and the proposed 24th edition of Standards is the 2 year compliance date set by the FDA. The Assocation Bulletin is a little confusing since they state the effective date of the rule for blood and blood components is April 26, 2006. What would have been better was to use compliance or implemenation date since the FDA "effective" date was April 26, 2004. Please correct me if i'm wrong.

After reading your post, we were wondering if you dispense aliquots in syringes? If so, what barcodable product label are you using? We are considering using a "divide" label, but can't seem to locate a label for "CPDA1, irradiated, leukoreduced, divide"

[Igloo Cooler Validation]

I validated each cooler but then we do quality monitor periodic check of coolers twice a year so that all coolers get checked annually.

You must pack our coolers per manufacturer instructions. There are specific instructions for "conditioning" of coolants. The instruction say to freeze at certain temperature for the frozen pack(s) and to refrigerate other packs. If you e-mail me I will send you the validation.

I also am validating a small temperature data logger that records temperature and downloads this to a PC for chart output. That way we can verify the storage of products not in our control. The problem has been that it is sensitive and we need to educate nursing not to take the logger out of the box or cooler when they remove the products. We see spikes on the charts where with regular thermometers they take ~10 minute ti change so you don't see the spike when they open the box/cooler.

We need to revalidate our coolers, as now we understand that they are considered to be storage, not transport. Our coolers won't keep the blood cooler then 6 degrees when packed according to our protocol. We use 10 units and wet ice in our validations. Any suggestions?

We are considering using the Insul-ice instead of wet ice. Have you heard anything about the success of this coolant?