Groupsites are branded collaboration communities that empower groups of all types and sizes to communicate, collaborate and connect around a shared mission, organization, cause or company.
$99/month
All-inclusive
No per-user fees
Try FREE for 30 days
No credit card required
After free trial ends, 30 days notice prior to cancellation
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.
We have run into this same issue. All of the waived devices (even non-waived) I have found are stating for Coumadin/Warfarin monitoring only. Any other use would be off-label and modified FDA/LDT. We use the Coaguchek in various settings, including modified FDA in the ED for stroke protocols and in the IR. It is not easy and we have had to train some providers since RNs don't meet the qualifications for high complexity testing personnel. I think maybe the Hemochron Jr PT has a bit more wiggle room, but it is mod complex and I'm not sure if it is still supported.
