Hello everyone,

I need help setting up a validation protocol for a Terumo sterile docking device. I assume a certain number of acceptable "welds" must be performed but beyond that, I don't have any other ideas. Any suggestions??

Thanks!

We went with a couple wet-to-dry and dry-to-dry connections for each of the different kinds of tubing that it would be used for (different blood products and aliquot containers).

IQ, OQ, and PQ for validation:

IQ: verify that all installation needs are met that the manufacturer requires.

OQ: operational, check to make sure it does everything the manual says it should (does it beep when done like it should? etc)

PQ: performance, welding with all types of tubing, multiple welds with no leakage, etc.

We are considering purchasing the Terumo  TSCD II Sterile Tubing Welder for our Transfusion Service. We are not currently registered with the FDA. Would we have to register with the FDA if we used this device to split units and make neonatal aliquots? I'm thinking we wouldn't since we're not actually making a new product. 

Registration would not be required.

Terumo BCT has a Weld Integrity Kit that you can purchase for your validation.

https://www.terumobct.com/location/north-america/Documents/306620262A-web.pdf#search=integrity kit

You do not have to register with the FDA if you are dividing a product into smaller portions.

However, if you are creating something new so the end product is different from the original product THEN you must register with the FDA. An example of something new would be to use FFP and RBC to create whole blood for an neonatal exchange. The end product is not the same as the beginning.

At my last CAP inspection, the inspector insisted that I needed to be registered with the FDA because we thaw plasma to Thawed Plasma with a 5 day expiration. I knew we didn't have to register but I didn't have proof at that time. I found my proof later on the AABB website 2012 Ask the FDA and CLIA Transcript. Question #29 covers the questions of when you are supposed to register with the FDA. I printed the whole transcript and keep it in my file for future need. Hope it is still up on the website.