-
I do know that the American Red Cross is moving toward "predominantly male donor plasma". I use those terms because we are not yet making a claim that all plasma is from a male donor. This was presented at AABB, so this isn't a secret or anything. I was actually the project lead for Dr. Benjamin for that initiative at ARC and how to manage apheresis donors is definetely a large concern for ARC as well. We also collect double red cells, which... are usually from a male donor. You risk cannabilizing one initiative for another. A have since taken another job within ARC (so if anyone wants to talk equipment- call me!) but when I left manufacturing, there were no talks (yet) regarding plts. Apheresis plasma yes, but not plts. -
100% LR does make inventory management a bit simpler but has the reimbursement issue been solved yet? I know this was a huge issue for hospitals. Even though data was produced showing that 100%LR can reduce costs by reducing the amt of transfusion reaction work ups (febrile mostly) and certain surgery stays were proven to be decreased, administrators had a hard time taking the hit to the bottom line to pay for LR products.
-
That is correct, you may use manufacturer's direction to establish frequency. When the manufacturer states no frequency, monthly still applies. Here is the link and the actual entry of approval from the FDA regarding the calibration of thermometers: http://www.fda.gov/cber/blood/exceptions.htm 21 CFR 606.60(: Calibrate digital thermometer according to the schedule recommended by manufacturer, instead of monthly as required by regulation. [Variance request no longer needed when following manufacturer’s instructions, as required by 21 CFR 606.65(e)] Calibrate Traceable Memory Monitoring Thermometer quarterly, instead of monthly as required by regulation. The thermometer’s package insert did not include recommendations for frequency of calibration; therefore approval was based on review of submitted data.