Hope everyone is doing well.
I need some guidance on evaluation on Biocompatibility testing.
Intended use of our product(tube set) is to provide extracorporeal blood path during treatment similar to dialysis and therefore we need to perform biocompatibility test.
This tube set is going to be used for 8-10 hrs maximum during the treatment and tube set is intended for single use only.
Patient will be exposed to new tube set next day for several treatments, (i.e. multiple exposure of limited period).
Now, according to standard, tube set falls in limited contact duration(category A < 24 hrs) but if you consider multiple treatments of 8-10 hours it falls in prolonged use(category B > 24 h and < 30 days).
We approached 2 test house for quotes and both concluded contact duration limited and prolonged use respectively and that will affect the biocompatibility test need to be done.
Could anyone please guide me on category for defining the tube set with some proof or rational for a limited exposure disposable tube set with multiple exposure with new tube sets for a number of treatments?
Many Thanks in Advance,