GEM Hemochron 100
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We currently have a fleet of Hemochron Signature Elites that we've had between 4-5 years. They've really been workhorses for us, rarely do I have to send one in for repair. We did see a demo of the GEM Hemochron 100 and it has some nice updates. Has anyone went from the Sig Elites to the GEM 100? What benefits did you see? I'm trying to decide if I want to budget for them or hang on to our Elites a little longer. Thank you!
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Wireless
Touchscreen with traffic light status indicator
QR code to eliminate scanning in the cartridge packages (depending on configuration)
HOWEVER, there is a big negative. The FDA imposed Werfen to place a statement in the literature that disallows action to be taken on "greater than" results. (I know there was a Sig Elite memo in ~2020 that stated something similar, but the vendor never updated their package inserts/operator's manual to state this.) We have some areas (like Cath Lab) that give a large heparin bolus in emergency cases just to make sure that the patient is anti-coagulated prior to the initiation of the procedure. They would use the "greater than" Sig Elite result to note that the patient was sufficiently anti-coagulated, to discontinue heparin dosing, and the procedure could start. Now with the GH100 statement, these areas cannot use the same workflow.
I just recommend reviewing the vendor literature and how your testing areas use the ACT results prior to implementation.
Good luck!
We have QML and use the Links tab (GH100 Configuration) to configure it.
Staff will repeat the test (using a new sample to rule out preanalytical errors).
If another > result is obtained, POC staff will manually send over the "result" to the patient's chart. All that is actually sent is the "out of range high" instrument error, not a true result.
Then, POC staff will credit the testing charges so that the patient is not billed for what is essentially an instrument error message in the chart.
We met with our compliance and legal teams and determined this was the best way to handle these results. We also wanted to enable the testing area to be able to document that they ran an ACT test, when indicated, for the procedure. Werfen/FDA does not allow action to be taken on these results, which we have noted in our procedure, too.
Any advice is much appreciated!
This operator list and password issue is a bump in the road that is holding up our go-live. Any ideas would be appreciated!