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Is FDA Registration required?


bmarotto

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  • 3 months later...

If the blood transfusion slip has a peel sticker with patient & unit information but no bar code for scanning, does the slip have to be registered with the FDA?  I am trying to create a new transfusion slip that would stick a peel tag to the back of the blood product that indicates the patient & unit identifiers so that when the unit is hung, the information is still attached to the unit when the transfusion slip is detached from the unit.

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If the blood transfusion slip has a peel sticker with patient & unit information but no bar code for scanning, does the slip have to be registered with the FDA?  I am trying to create a new transfusion slip that would stick a peel tag to the back of the blood product that indicates the patient & unit identifiers so that when the unit is hung, the information is still attached to the unit when the transfusion slip is detached from the unit.

The adhesive on the label needs to be FDA approved in order to be placed on the blood bag. It's not easy to find that out by the way.

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Thank you for the response, Terri Bostock.  I truly appreciate your help.

 

Has anyone been able to obtain the Safety Data Sheet from their vendor regarding the type of adhesive used?  Is there a specific type of adhesive that the FDA approves to be used?

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Thank you for the response, Terri Bostock.  I truly appreciate your help.

 

Has anyone been able to obtain the Safety Data Sheet from their vendor regarding the type of adhesive used?  Is there a specific type of adhesive that the FDA approves to be used?

The label vendor was able to provide me with a document that they were approved for blood bags, but I never saw an SDS or anything, or even a mention of a specific type of adhesive that is approved. I would also like more info on this.

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In the past I contacted Shamrock about their labels and they were quite helpful. The adhesive (according to them) has to be food safe to meet regs. They stated that their Blood Bank labels/adhesive met the requirements for that use. They also directed me to specific sections of the CFR for more information. (Haven't done anything with that for years, so I don't have that info anymore.)

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  • 1 month later...

Yes, this does require FDA registration. Preparing syringes/aliquots for babies does NOT require it, but preparing units for exchange transfusion DOES.

I was looking for information on aliquoting for babies.  We never transfuse babies but we have a new pediatrician on staff that specifically asked how to order an aliquot to transfuse a baby.  We are currently NOT inspected by the FDA and I wanted to say we couldn't prepare aliquots so we don't open ourselves up for FDA inspection. (A CAP inspector told me it would)  We also don't have bags or syringes available. Any advice?

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If you are simply making aliquots, e.g., just providing a smaller sample of the same product, FDA registration is not required.  If you're making a new product or doing other manipulations, such as adding Plasma to Red Blood Cells to create a Reconstituted Whole Blood unit or washing the RBCs, then FDA registration is required.

 

 

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I was looking for information on aliquoting for babies.  We never transfuse babies but we have a new pediatrician on staff that specifically asked how to order an aliquot to transfuse a baby.  We are currently NOT inspected by the FDA and I wanted to say we couldn't prepare aliquots so we don't open ourselves up for FDA inspection. (A CAP inspector told me it would)  We also don't have bags or syringes available. Any advice?

 

If your blood supplier can supply you with a unit that has extra (pedi) bags sterile docked to the original unit (we get one with 4 pedi bags attached) - you can do aliquots for babies without all of the needles and syringes.  Also the entire procedure remains "sterile" without introducing any needles or spikes to the original units.  You do have to have a tube crimper set or a tube sealer to seal off the pedi bags (I finally got one of the Terumo T-Seal II units - wonderful!!).  We photocopy the original bag label, make all alterations to that label, as needed, and tape it to the pedi-bag.  It has worked out well for us and no inspector has cited us yet.  And yes - one inspector did point out that we had to add the reconstituted RBC/FFP exchange transfusion units to our FDA registration (we already had one for Irradiation), even though it is not one of the choices listed on a FDA rgistration form - we had to write it in.  We had to bring the whole team back up to speed with that procedure (YUGH!), only to have them use it once in 2 years so far!!!!  They call down and want you to get everything ready and then the current, very effective treatments for high bilirubins get the bilirubin turned around without the transfusions.  Thank heavens the babies don't have to go through that, even if it scares us to death every time they ask for this stuff.  I constantly wonder how they keep their competencies up on this complicated procedure.

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In our last CAP inspection, I was told that we had to have FDA registration to thaw plasma and to extend the expiration to 5 days. I knew it wasn't right but didn't have anything to pull out to prove my point. I didn't want to argue my point too much and make him too mad. At least he didn't ding me. Later, I dug around on the AABB site and found this that I have included below. I hope it helps someone. It is still available. I downloaded the whole thing to my computer in case I should ever need it in the future.  :)

 

2012 Ask the FDA and CLIA Transcript

Page Content

Ask the FDA and CMS/CLIA
October 8, 2012
AABB 2012 Annual Meeting
Boston, Massachusetts

 

Question 29: When is a transfusion service required to be FDA registered? Do the following processes require the facility to be registered? These examples were received from 4 different facilities.

  • thaw plasma and split RBCs
  • receive washed red cells from the blood supplier and then add plasma for an exchange transfusion
  • divide red cell or platelet products for pediatric use
  • re-label thawed fresh frozen plasma to thawed plasma

MS. CIARALDI: There's an easy answer, which is no, yes, no, no, but what I'd like to do is just take some time to explain why. The regulation that states who must or who is required to register is 21 CFR 607.20. It says specifically any establishment that manufactures a blood product must register, and there are some other criteria, but that's the main one that applies here. Additionally, there is a regulation 21 CFR 607.65(f), that lists some exceptions under which a transfusion service does not need to register, but that's a very limited and specific list. Now, to go on to the specific examples here, what I'd like to do is bunch bullets one, three, and four together. In those three situations, a transfusion service would not need to register. Thawing plasma to prepare it for a transfusion we don't consider the manufacturing of a product. So that is why that particular practice is exempt. In addition, splitting or dividing units for whatever reason, usually pediatric reason, is also not manufacturing a product. The end product is the same as the starting product. It's just smaller volumes. So that is the rationale behind why that would also not need registration. However, in the second bullet, washed red blood cells has plasma added to it, and the final product, which is sometimes called reconstituted whole blood or reconstituted red cells, is used for exchange transfusion. The answer to this is that, yes, registration is required, because the transfusion service is making a new product. The reconstituted whole blood is the new product. The final product, the whole blood product, is different from the two original starting products. So there is manufacturing of a product going on in this particular situation.

MODERATOR: Thank you, Judy.

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