[Neonatal Exchange-FDA Registration]

Does anyone know if FDA registration is required if a hospital reconstitutes RBCs with plasma for a Neonatal exchange transfusion?

[Reconstituted whole blood alternatives]

On 8/26/2016 at 9:16 PM, CarrieM said:

They are for exchanges, and the NICU tells us the desired volume.  We reconstitute to a standard HCT, and issue in a transfer bag.  We use SoftBank, and it basically allows us to create a pooled product so all the components are included on the label.

Could you share your policy and procedure? We have a policy but it's not very good. We haven't performed one in years but we have been transfusing a lot of babies lately and I'm thinking there might come a time very soon where we might have to. Thanks!

[Neonatal Exchange Transfusion]

here is what we do..hope this helps.  We also use Meditech

 

Thank you DIANITA!

[Neonatal Exchange Transfusion]

We have Meditech also. Thanks so much!

[Neonatal Exchange Transfusion]

Does anyone have a Neonatal Exchange Transfusion Policy they could share with me? We have a policy but we haven't performed one in years and I just want to make sure our policy is up to date and detailed enough for the techs. Our hospital is going to become a level 3 NICU so I suspect we will start getting orders for Exchange Transfusions.

 

Thank you!