ACT Platforms

We first heard that Medtronic was no longer manufacturing their ACT devices about a year ago. Since we would be unable to replace any of our 22 ACT+ instruments going forward, we decided to go with the Hemochron 100. We have not yet received the devices, however other hospitals in our Advocate Health System have been using the Sig Elites for years and are pleased. We haven't yet encountered any issues with receiving our aqueous QC from Medtronic. 

Happy New Year! 
As of December 12th, 2023 we replaced all of our Hemochron Signature Elites with iSTAT for ACTs. They were due to be replaced anyway so we had to decide which instrument we wanted to continue forward with. I can send you the pros and cons sheet I made up for the discussion I had with our C suite if you want! Also a big issue with us is our hemochrons weren't interfaced and it would cost a lot to do that, whereas we already had iSTATs in other departments so it didn't cost anything to add more.

We currently use the Sig Elites in Cath labs, EP, CVICU, CCU, COU, EVOR, and Neuro labs. We are installing the 100's now and phasing out some of the Elites. We have both interfaced and use middle wear for the Elite, not configuration manager. Give me a call if you'd like to discuss and bounce ideas for the ACT. We did look at i-Stat but ruled them out.

Hi Cat,
 Here at MLH (PA),we have been using the Hemochron 100s (ACT-LR)) for over a year in our Cath Labs and for about 7 months (ACT+) in some of our ORs. Previously, we used the Sig Elites in the Cath labs and the ACT Plus in or ORs (perfusionists only). At another facility I have had experience with the iSTAT as well, but for chemistry tests only. All of our instruments currently are downloading and picking up their configuration from the Abbott RALS system.

 After working with both instruments, cartridges and tech support, I definitely think we made the correct choice, although there have been a few issues along the way.

I would be happy to discuss off line if you wish.

We have been using the Hemochron Sig Elites over 10 years and are now switching to the Hemochron 100. The Devices are primarily used in EP, IR, PTU and the Cardio-Thoracic/Transplant teams. 

We had Sig Elites for more than 10 years and we implemented the GEM100s last year. I have nothing but good things to say about the GEM100s. The Sig Elites were not as easy to program and get reports from, but we didn't have them connected to GEMweb.

I've always had great customer service from Werfen and no issues with reagent availability that I can recall over the last five years. I believe they have stateside manufacturing facilities for all of their analyzers.

For people who switched from Sig Elite to GEM100s, would you need to re-validate? Or would you just switch since the methodology is the same?

Our Application Specialist from Werfen spent two days at our facility doing the validations from the Sig Elites to the GEM100s. They set up a validation plan approved by your medical director prior to arrival. 

Yes, the validations will have to be done. I know that Werfen reps will tell you it's the same methodology, but that isn't exactly true. If you press the reps about it being the same methodology they will explain it to you. In addition to the validations, there has be a 30-day control performance done to demonstrate that the instrument gives stable results between liquid control performances (which is each lot, each shipment and every 30 days). The medical director here even required a normal patient range study (that was the worst) despite being told we could reference literature.

I did not know about 30 day control performance, but we QC all devices/tests weekly as part of our IQCP. ACTs are too non-precise for my comfort and I need all of our operators proficient in the QC vial handling process so that proficiency event handling isn't a foreign process to them. I don't like Werfen's liquid QC recommendation frequency, TBH.

Normal range study?? wow. I'm so sorry. 

Ken, I find the laboratorian in me balking at only running the liquid controls once a month, but it is hard to argue this with the cath lab staff and their management when they too read the manufacturer's recommendations. The economic climate being what it is every penny counts. We have been doing this for a few years now and there have been no adverse issues with only running the control as the manufacturer describes.

Melissa, I totally agree. In five years I never had any issues (other than non-proficiency at handling lyophilized vials during proficiency) until this last month. 
We received a compromised shipment of controls and our Cath Lab and Critical Care staff were repeating it over and over again without telling me. I would've found it during monthly QA, but by then we might have blown through all six boxes of the compromised shipment. I was able to sequester four boxes that would've been mostly wasted. 

The bad QC also had staff questioning patient results. No one else had reported issues, but most other labs are doing the monthly QC route and are used to level one failures. The questioning of patient results was the worst part; if we'd been doing monthly QC these failures would have been a much longer term issue and probably would've concerned our Cath Lab greatly. Of course, patient results weren't affected, but I was still glad to deal with the issue within a month instead of over a longer time period and end up with more users becoming concerned.

I find that weekly QC provides a convincing visual to prove that the devices are functioning as expected when their results are questioned. Cath Lab gets worried about device accuracy at least every two years and it always helps to offer all of my QC/QA data to demonstrate that they are functioning properly. I also pull my biannual heparin response correlation to offer.

I feel for you on the budget constraints. It is always hard to fight those; takes a good argument that the expense is actually saving money or increasing patient safety or is increasing staff proficiency for regulatory testing, etc. 

HI Cat,
We changed over from the ACT Medtronic to the I-Stat ACT, and I am happy to say I will never regret that move.  The accuracy alone in the clot detection methodology using the ACT-K has made a significant impact for our patients. It did take a little convincing. to our doctors, but the education material provided is excellent, and still to this day our CIRV doctors will still stop me in the hall to thank me, (which never happens typically).  I would be more than willing to share the power point. 
Also, the training of staff has been much easier, and with the use of RALS middleware it is easy to stay organized. The proficiency testing through CAP on i-STAT ACT's is not my favorite, I feel strongly there could be some improvement on CAP's part to introduce samples that do not require multiple mixing steps, and the pipetting of the clotting agent can have it effect on results, but so far, we have had great success with no incorrect submissions. However, I do closely monitor specimen preparation, as it is not anything like a patient sample.