Biocompatibility Device Categorization: Priming with Blood

[Freddo]

Hi All,

We have devices used for extracorporeal circulation of blood. Some parts of the device are only used for "Priming" of the circuit, which means that said parts come into contact with the priming solution (usually Saline solution), but not directly with the Patient, since they are removed from the circuit before the actual application of the device. Since the priming solution is later mixed with the patient's blood, we consider these parts of the device as having indirect contact to the blood path acc. to Annex A of ISO 10993-1:2009.

The question that arises now: In some cases, the device is primed using blood from a blood preservation (so not the patient's own blood).

Can we still consider These parts of the device as having only indirect contact to the blood path? Although it technically has direct contact to blood?

Thanks for the answers

Freddo

 

[planB]

Freddo,

if I understood you correctly, you use 2 different priming solutions, which are both not patient blood, that are used in the very same way.

Thus, the nature and duration of patient exposure with regards to your device compartment is independent of the actual composition of the priming solution. Therefore, you should end up with the same device category.

HTH,

Gerhard