Avoximeter 1000E Validation

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We are currently validating the Avoximeter 1000E for CathLab. Has anyone had any issues with validating or performing regulatory testing on these devices?

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Hello, I validated the AVOX1000E for my Cath Lab in 2023. I would highly recommend using RNA medical controls (I can forward you the site and ordering info) and NOT use the Werfen controls as these had many problems with passing QC. I haven't had any issues when I changed over to the RNA medical controls. We did a method comparison study to the ABL800 in core lab and the O2 saturation was great, however the total hemoglobin had several bizarre outliers that I couldn't find an explaination for. Most of my samples had a bias of less than but then had 4 samples out of 100 with a huge bias of 5 to 20 g/dL difference. We decided not to clinically approve the total hemoglobin value and only use the O2 saturation for Cath Lab. They didn't mind since they only cared 
about the O2 sat to enter into their MacLab calculations. I have more information I can share if you'd like specifics. Jacob.Fray@dhha.org 
Thanks,
Jake

I've validated 3 of them over the last 6 years.  Agree with Jake, RNA medical controls and the CVC 223 CO-Oximeter Calibration Verification are great and I have never had an issue with those.  

I also struggled with tHb comparisons.  We didn't feel comfortable not approving tHb, since you can't turn that parameter off and the Cath Lab staff can see the result.  The only thing that has worked for me for tHb validation and the twice annual correlations is to use freshly drawn heparin blood gas syringes (VERY well mixed and less than ~4 hours old) drawn at the same time as a purple top.  We sit the Avox right next to the ABL90, run the Avox first, then immediately run on the ABL90.  The purple top is run on our core lab hematology analyzer.  Our acceptance criteria for tHb on different devices is 7% or 1.0 g/dL.

We have used the AVOX 1000E here for 20 years and have never had any issues.  We use RNA Medical QC and CalVer kit.  Cath Lab here is only interested in the O2Sat (%HbO2).

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