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does anyone have any recommendations for a *waived PT/INR device? There are a lot of devices available on the market but not sure what is the best and what everyone uses.
I'm reviewing an SOP for an offsite that uses the coag-sense PT/INR waived device and I'm questioning whether or not it is suitable for the intended use as defined by the manufacturer's IFU. They are not really using at the moment but have intentions of using it.
Does the SOP match the intended use as stated by the manufacturer's IFU? I don't think it does. Any opinions on this would be appreciated.
I would agree that the SOP does not match IFUs, specifically for the preoperative. One could probably argue postoperative would match, and then obviously the routine INR monitoring seems to match IFU just fine. I have two clinics (Family Medicine & Coumadin) that use the Roche CoaguChek XS system. Both these clinics only use for monitoring patients, not for anything regarding before/after procedures. We would run an INR in the lab for those situations.
