Replacement i-STAT
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Good morning,
We have received a new i-STAT 1 as a replacement for one already in use. The same testing will be performed on the new meter (Ionized Calcium).
We were told by Joint Commision on our last survey that the i-STAT is considered a "meter" and not a test device -- that the cartridges are the test device, and we only need to validate the cartridges.
However, I feel like we would still need to do a meter performance or some type of validation? Patient correlations? This will be my first time putting a new i-STAT into use. Thanks for any guidance!
We have received a new i-STAT 1 as a replacement for one already in use. The same testing will be performed on the new meter (Ionized Calcium).
We were told by Joint Commision on our last survey that the i-STAT is considered a "meter" and not a test device -- that the cartridges are the test device, and we only need to validate the cartridges.
However, I feel like we would still need to do a meter performance or some type of validation? Patient correlations? This will be my first time putting a new i-STAT into use. Thanks for any guidance!
6 Replies
I was told by Joint Commission that when receiving a new iSTAT that you are to perform Calibration Verification for all of the cartridges that you run to ensure the meter is working as it should. You do not need to run Calibration Verifications every 6 months since you can't make any changes or adjustments to the iSTAT anyways, so it is just for "new" iSTAT's. Abbott and Eurotrol sell Cal/Ver material.
When I get a new iSTAT I perform Calibration Verification.
We got replacements last year. We did a linearity and precision on each. We only use them for creatinine.
Abbott has recommendations for replacement and/or additional instruments written somewhere. We are CAP not JC but I would think you would still want to follow at a minimum Abbotts recommendation. Call Abbott to find out where they have that written. I believe it includes cal ver kit, patient comparisons, and 2 levels of QC for a minimum of 2 days for non-waived cartridges.
Thank you so much everyone for all of this helpful information! You are amazing -- I appreciate it!
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