Slip Slidin’ Away – the i-STAT Debacle

On the morning of January 15, 2020, the grip on the point-of-care market enjoyed by the Abbott i-STAT system began a free fall that could cause permanent pain for the flagship analyzer in this market.

Slip Slidin’ Away – the i-STAT Debacle

On the morning of January 15, 2020, the grip on the point-of-care market enjoyed by the Abbott i-STAT system began a free fall that could cause permanent pain for the flagship analyzer in this market.

 

Customers had no advance notice of the debacle, and many users of the i-STAT found the news distressing.  

The changes are complicated to follow and understand, but you can find the letters released on that morning on the Abbott website. In summary, one of two letters released to users announced that some cartridges will no longer be available for the i-STAT after May 1, 2020. The other letter was nothing less than jaw-dropping: cartridges that had been in use for about five years suddenly appeared to lack FDA approval, and continued utilization might put users in jeopardy with accreditation agencies and require a different lab certification or specifically a different CLIA license.  

A Very Big Deal 

A CLIA license certifies a lab both by its state and by the Centers for Medicare & Medicaid Services (CMS) before it can accept human samples for diagnostic testing. Now it should start to sink in… the changes described in the letters are very big deal that had lab, nursing, and other staffs scrambling for many days beyond January 15. The scramble continues today. 

The i-STAT is a multi-faceted analyzer that can perform a multitude of tests. The current changes focus primarily on blood gas testing, lactate, and other chemistries. Therefore, the comparison below is related to primarily point-of-care blood gas analyzers. Some interesting, but not surprising, shifts now seem to be occurring in this market in the space of less than 45 days.  

  • Abbott (iSTAT)  
  • Siemens Healthineers (EPOC) 
  • Radiometer America (ABL90)  
  • Nova Biomedical (STAT Profile)  
  • Instrumentation Laboratory (GEM5000)

Author:

Dennis Matricardi, MS, SM(ASCP)DLM

Clinical Analyst

Service Line: Laboratory, Pharmacy

TractManager activity BEFORE the release of the letters by Abbott:

TractManager activity AFTER the release of the letters by Abbott: 

Clearly, i-STAT activity has dropped by more than 50 percent since the release of the letters. The EPOC system by Siemens Healthineers is the clear winner, with Radiometer America’s ABL90 also showing a distinct increase. Abbott i-STAT may have real problems with customer loyalty in the future, and these shifts may become more dramatic over time. 

Be Deliberate, But Act Soon 

Understand this market and what is going on before you make a Point-of-Care Analyzer choice. Depending on the specifics of your i-STAT situation you may have to make choices that move your lab from a (CLIA) Certificate of Waiver to a Certificate of Accreditation or Certificate of Compliance. You can stay with i-STAT, but you will have to make cartridge changes/compromises. 

 You will be dealing with very complex issues as you make a change in this sort of fluid situation. Talk to an expert, review the data, don’t walk it alone; accreditation agencies are likely to be watching this situation very closely. Don’t lollygagmake your changes with great expediency. You might find backorders for the product you have selected, so have a back-up plan. The entire country is scrambling on this one. 

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