PT/INR meters/analyzers for ER/possible stroke patients

I am getting my Hemochron Signature Elite validated for this very purpose in 2 weeks. Accriva has the claim to use the device for stroke, therefore it is not off label. They are able to detect a true clot on their cartridge, which is something no other POC platform has.

This is a problem for us as well.  We currently have iSTAT PT-INR in our ED and have wrestled with the language in Abbott's Cartridge/Test information sheet which while it indicates "for use with oral anticoagulant monitoring" it does not include prohibitory language forbidding its use on those not on oral anticoagulant.  Interesting to see that many of you are also interpreting the language as "not OK" for non-oral anticoag patients.

I know some in our system are exploring Hemachron SigElite for this purpose.  As much as I do not want to introduce yet another non-waived device to our ED staff, this may become inevitable.

I didn't realize the Hemochron was FDA approved for other uses than just monitoring warfarin therapy.  Can you send me the literature to support?

As for the iSTAT.  My medical director called and talked to "someone" at iSTAT who confirmed in can ONLY be used if the patient is taking warfarin to monitor therapy.  Their statement to him was that it could not even be used in a situation were a patient was told to stop warfarin prior to a procedure.

I am away at a conference until August 5. If you have an urgent POC issue, Pauline Kamenyi at 24219 or Meike Talley at 29397 for Sinai or Alana Agustin at 55816 for NW. You can also vocera point of care testing.
Thanks

Joann O'Connor
POCC for Lifebridge Health
joconnor@lifebridgehealth.org

410-601-5673

>>> "Mary Blank via POCT Listserv (Groupsite)" 08/02/16 13:10 >>>

Thank you for your reply James.

I spoke with Abbott's technical support today about PT/INR on I-STAT.  He told me that  doing PT on ER/possible stroke patients would be off label. Honestly, I was suppressed at his sincerity.

Slavica

I am away at a conference until August 5. If you have an urgent POC issue, Pauline Kamenyi at 24219 or Meike Talley at 29397 for Sinai or Alana Agustin at 55816 for NW. You can also vocera point of care testing.
Thanks

Joann O'Connor
POCC for Lifebridge Health
joconnor@lifebridgehealth.org

410-601-5673

>>> "Slavica Stoyanovich via POCT Listserv (Groupsite)" 08/02/16 13:15 >>>

Thanks for that information Mary.  Since even patients that are 'supposed' to be on oral anticoagulant often present for testing during lapses in their medication routine, it sounds like iSTAT PT-INR is inappropriate for this - and perhaps most - settings.

Wow, interesting Slavica - and thank you for that.  Yes, I am surprised at his sincerity as well - at least they are taking a stand one way or another with the issue.

I am away at a conference until August 5. If you have an urgent POC issue, Pauline Kamenyi at 24219 or Meike Talley at 29397 for Sinai or Alana Agustin at 55816 for NW. You can also vocera point of care testing.
Thanks

Joann O'Connor
POCC for Lifebridge Health
joconnor@lifebridgehealth.org

410-601-5673

>>> "James Beck via POCT Listserv (Groupsite)" 08/02/16 13:21 >>>

Thank you all for your responses. This is extremely helpful.

I am very impressed with what I have seen so far on Hemochron Signature Elite.  I need more literature that confirm the claims.

I will very much appreciate if any of you can forward literature you have or direct me to a helpful link.

Thanks! Slavica :-)

I think the Hemochron Sig Elite is a good device, but is not the best suited for POC settings in that it does not upload results automatically without operator intervention and/or power-cycling the device.  This makes it definitely out of sync with most POC devices.

James,

We are going to implement a Hemochron Sig Elite here in our Adult tower STAT ED Lab, could you give me a heads up on what to expect going forward.  They are wanting to have all their ED RN's have access and run this machine.  I personally don't think that is a good idea.  What are your thoughts?

Correlations

Studies

Connectivity

Penny Rose

I am away at a conference until August 5. If you have an urgent POC issue, Pauline Kamenyi at 24219 or Meike Talley at 29397 for Sinai or Alana Agustin at 55816 for NW. You can also vocera point of care testing.
Thanks

Joann O'Connor
POCC for Lifebridge Health
joconnor@lifebridgehealth.org

410-601-5673

>>> "Penny Rose via POCT Listserv (Groupsite)" 08/03/16 08:47 >>>

Hi Penny,

  I have not seen correlations with the Signature Elite PT cuvette yet.  We did do correlations with the ITC (Accriva) PT-INR instrument nearly 10 years ago and they were quite good.  That POC instrument is no longer on the market, unfortunately, especially unfortunate in that it was also CLIA-waived.  Accriva now offers only their PT-INR methods done on the Sig Elite (non-waived).

  While the technology and correlations for PT-INR on the SigElite may well be just fine, I have concerns about:

1. Having to implement an entire platform/new device for the purpose of doing only 1 test.


2. Connectivity.  The SigElite can do a serial or Ethernet connection; however, the result uploading process is not automatic.  The user has to actively either push the results via a data export function or power-cycle the device, to start an upload.  No other POC device is like that and as a result, this puts the machine a bit out of sync with the rest of the POC world.  The SigElite's primary place in the past has been in treatment areas where it is used for monitoring (cath lab, interventional radiology, OR).  Connectivity is not so much an issue there.  The ED setting is different and I am currently uncomfortable with the idea of putting a device like this in that setting.