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comment_26691

Wondering how all of you plan on implementing the new bacterial detection testing standard by AABB? We plan on using Verax since it will be the only test method that can possibly work in our institution. We wanted to pre-pool the platelets after testing using a sterile connecting device and then have the expiration date be the date of the unit that outdates first in the pool. We had been told by Verax that some places using their testing performed testing once every 24 hours, so we thought we could do the same with the pre-pooled products. As of today we still have no name of a place to call to see how they are doing it from Verax. Then we also found two obstacles to this thought. First, Verax's 510K is for testing up to 4 hours prior to transfusion. Second, FDA's document on SCD says that the product is only good for 4 hours, otherwise it is considered manufacturing. We spoke with one person at FDA a while ago and they said it would be okay to SCD the platelets but we are very concerned due to what is in writing. We are a Transfusion Service and not a licensed facility. Thoughts???? Appreciate your comments.

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comment_31376

We are about to go live with Verax testing. You are welcome to contact us. Baylor University Medical Center, Transfusion Service.

comment_31506

Just got around to this one. Anyway, we've been performing Verax testing for some time. However, we don't pre-pool our RDPs. We pool at the time of order and perform Verax testing on the pool itself. I'm just curious, though. Does your institution have their own donor center or do you get your platelets from a local blood center? If it is the latter, I would think it is THEIR resonsibility to address this issue for their clients. For example, a local blood center is going to apheresis and Acrodose platelets exclusively. If you'd like more information, don't hesitate to ask.

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