Best Platelet Testing for Hematology Lab
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Trying to find a good point of care device for platelet testing. We just got the memo about FDA shutting down the Beckman Coluters that we have for platelets and was asked to seek a good replacement for platelet testing.
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Just for my own curiosity - what is the need for performing platelet counts at POC?
They asked me if there was anything out there because they know they would have a harder time getting approval for bigger equipment under capital budget. they are just trying to find alternative testing due to the FDA shutdown on the Beckman analyzer.
I see.
I can't say I have ever seen a device that can do POC platelet counts. I am guessing because there has not been a defined need, thus far.
CBC testing with platelet counts I just found two actually: Sysmex corporation and
https://www.helena.com/hematologyAnalyzer.html this is a good product for pre-surgery if anyone is interested in it.
Hi Joseph. Which Beckman-coulter instrument got pulled from the FDA? Just courious.
Thanks,
Julie Brim, CLS
POC supervisor, Vancouver clinic
The best platelet instrument is in the Main Lab.
What is the rational for having one in POC? Convenience? Who operates the instrument? Nurses or lab staff?
Who does the QC on this instrument? Does it really beat the TAT of the Main Lab analyzer?
IS it always working? Statistics always good? How many do you do?
These are questions to justify an instrument outside of the Main Lab.
I can see if you are a humungous hospital and has unlimited budget.
You need a STAT lab wherever you are using this Platelet instrument.
I would say this is a good time to evaluate the necessity of this instrument.
Wow!
Hey Pet,
What is the rational for having one in POC? Beckman Coulter in the main lab has to stop performing platelets due to an FDA madnate so we are trying to find a new machine and they were coming to me to find out if there are any point of care ones because of cost. Who operates the instrument and runs QC? the laboratory staff does all of it the machine will stay with Hematology.
Hey Julie,
it is the DxH
Joseph,
I thought you meant Platelet instrument in POC setting.
You want info on a platelet instrument for the Main Lab.
That is why I question why do you need a platelet instrument in POC.
Pet,
Exactly looking for a point of care machine for the main lab.
Might be semantics, but if a machine is used in the lab, then it is not POC
With that said, there are smaller, low throughput hematology analyzers for running CBC's. We actually use the Sysmex POCHi as a POC analyzer, run by nurses for a CBC with 3 part diff reported. I don't think there are any devices out there that only perform a platelet count though, other than doing a manual count.
Beckman Coulter has a Class 1 Recall on the the DxH800, 900, and 600 related to platelets. Coworker received the MedWatch last week. FDA has not shut them down, they have remediation they need to do. These are hospital instruments, not decentralized. Hope this helps clear up any confusion
To add to what Jason stated - the 'fix' for the Beckman Coulter DxH platelet issue is simply a software update - no requirement to cease testing, at least not that we were made aware of. In fact the original notice goes back to 2018; the issue was recently revived because they needed to include 900 series analyzers in the recall/upgrade.