Validation Procedure for Cell Washer

[AMReagan1]

Does anyone have a validation procedure for a COBE 2991 Cell Washer? We are trying to validate ours.

Thanks,

AMReagan

[David Saikin]

What are you trying to validate? You should validate the instrument as you would anything else . . . define what you are validating; state how you are going to do that and what your expected results should be; DO IT; evaluate your results based on your assumption of what you should get. If the result is as expected, you have your validation . . . if not, then you need to figure out what is skewed (procedure/technicque/instrument failure/whatever) and proceed with further studies until validation occurs or cannot occur.

[AMReagan1]

Thank you David for your response, we are washing packed red blood cells and what we are trying to establish is the "expected" results for the washed product. For example, the recovery rate of red cells, volume lost, etc. There are specific factors to evaluate which determine if the cell washer is working properly, and we are trying to get that data. COBE used to provide a validation procedure, but they are no longer allowed to because it is considered a conflict of interest.

[David Saikin]

I find their reasoning hard to believe . . . all the computer companies provide validation templates for their BBISs, which are also considered Medical devices. Good luck.

Edited November 19, 2010 by David Saikin
poor grammar

[jdo1217]

In my former BB when we were validating our red cell washer for use with PUBS-FIT, we checked the protein content of the last wash supernatant to verify that the number of washes (can't remember whether it was 2 or 3) was adequate.

[BBQuality]

Just curious if you ever located a validation plan. Need to embark on a similar project and am curious what others do