POC PT/INR on the ISTATs
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Is anyone using the ISTAT PT/INR on code Strokes or STEMIs in the ED on patients that are on Coumadin? Do you mind sharing your process with me?
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This cartridge is only approved for monitoring patients on Coumadin therapy.
Jeremy, I have been trying to find the FDA Intended Use that specifies it is only for monitoring patients on Coumadin therapy. Do have a link/source that you could share? Thanks!
It is in the I-Stat CTI sheet for PT/INR.
The CTI says it is "useful for monitoring". It does not say "it is only used for monitoring". How many places use it as a Stoke Protocol ED PT/INR - without coumadin therapy status. Have there been any inspection issues with this use?
Karen - we went round and round with this at our facility as well. I concur with the statement you quoted from the CTI - which to me is not a strict prohibition of using it for patients not on Coumadin, especially if you have included non-Coumadin patients in your validation study. But others at my health system interpreted what I saw more as simply as a sin of omission (just because they didn't expressly include non-Coumadin patients in the CTI doesn't necessarily mean it is prohibited) as Abbott stating it should only be used on Coumadin patients. I think you could just as easily make the alternate argument that Abbott does not include language in the CTI that says it is prohibited/off-label use.
James - the semantics are tough. We did have non-Coumadin patients included in the validation as it was validated in the ED with stroke protocol patients and it's use is tied to the certification the hospital has. This isn't one of the bigger battles I am involved in so it is on the back burner for now for the program I manage.
Very frustrating.
As an FYI, I am told Abbott has in development (maybe further along than that now), a PT/APTT cartridge that will not have the Coumadin-only 'stipulation' (however you interpret it) at all. Have not heard a street date though.