Hi,

Does anyone have an idea on how I can validate the Charter Medical Neonatal Syringe set with 150 micron filter?

What do you want to validate it for? Storage time? Temperature retention? Ease of transfusion? I'm not even sure why you would consider validating it. Did you validate the transfusion sets used for adult transfusions?

:disbelief

Thanks John

I think what you are looking for is validation of the process you will employ with the syringes? As John pointed out, validating the syringe itself (unless you are comparing it to another syringe for ease of use or problems with leakage, etc. to decide which to purchase) is not productive. If you are looking at a process change from your current method of dispensing blood aliquots, then there may be things that need to be validated.

I am considering changing manufacturers of this product due to pricing. What do I need to do from a validation/documentation standpoint?

We have been looking at this filter/syringe as well. Our question is about the 150micron filter. The tech manual says blood should be filtered with a 170-260 micron filter. Would this 150 micron filter be acceptable for neonates and if so what would you have to do to prove it is ok? We have tried to contact the manufacturer about the filter but no one seems to know much about it. It was our belief that the filter/syringe system was designed specifically for neonate transfusions.

Hi all,

Christie from Charter Medical here. If you have any questions surrounding validation or filtration of blood for neonates, please contact me directly.

Best regards,

Christie Loe, MT(ASCP)SBB

Sr Key Account Manager

Charter Medical Ltd.

cloe@lydall.com

you don't need to validate that product - JOhn is right on . . . you can use a smaller filter with impunity, it might take a bit longer to infuse. You could not use a larger filter.

We have been using this filter/syringe set for some time. It makes preparing the aliquot so easy we keep thinking we have forgotten a step.