POC panel talks diabetes care, data management, CGM

Dr. Fuhrman, how has that affected life at OhioHealth? Was it a major cause of concern, and is it still?
Dr. Fuhrman (OhioHealth): You could categorize it as a major cause of concern because the glucose meters that we went with had been recently FDA approved, and the FDA had only recently put in that requirement. So the older meters didn’t have a claim but they didn’t have a not claim, whereas the meters that we went to specifically said they had not been approved for use in critically ill patients. But after talking with the CAP and with our colleagues in the point-of-care world, it was clear, and somewhat odd, that critically ill had not been defined by anybody. So we got together with our clinicians, nurses, and lab folks, and we just came up with a pretty narrow definition for critically ill that we could follow. Other places have done something similar. The most important thing is to do no harm. You don’t want to remove point-of-care testing from patients who need it.

In our 2019 point-of-care panel discussion, concern was expressed about infection control in point-of-care devices. Several people spoke about contamination as a major concern. Dr. Fantz and Todd, is that concern still warranted?
Dr. Fantz (Roche): Yes, it absolutely is still a concern. I think people are surprised about the cleaning requirements. The time you need to wait in between patients is sometimes overlooked. But auditing best practices can help put the focus back on the patient and the reasons why those steps are necessary to decrease the risk. I’m not sure you can eliminate all contamination, but you do your best to follow the best practices and keep the patient top of mind.

Todd Cullen (Arkray): One of the big challenges we have in our market specifically is cross-contamination with multi-resident meters. The challenge we have is in their workflow and how they’re managing that large population and cleaning and disinfecting those devices on a regular basis and making sure there is no cross-contamination of pathogens. There’s a significant focus in long-term care facilities on making sure there isn’t any infectious disease cross-contamination. They’re fined for not following procedures. So we do have guidelines we help them out with to try to manage that.

Dr. Fantz (Roche): It’s not just the instruments, though. It’s the strip, too. It’s following the proper procedure with changing gloves and cleaning with the wipe cycles.

Todd Cullen (Arkray): Yes, absolutely. There’s a protocol we have that has been adopted by the CMS and others that they’re following, and we make sure as a manufacturer we follow the protocol when they’re using our devices, because even micro-blood and other things you can’t see are cross-contaminating all the time.

Dr. Fuhrman, would you care to comment on this infection control issue?
Dr. Fuhrman (OhioHealth): I have an excellent point-of-care team that goes out and regularly looks at the meters. We also audit the cleanliness. We include it in all of our training. And if we go to see a meter and we see anything, we immediately meet with the nurse manager in the area and point it out and discuss it and let them know it’s a big issue. They’re doing much better than they had been, and I think it’s because they have a better sense of how important this is and the issues around infection control. There’s been a lot more visibility in many arenas, so we’ve gotten a fair amount of traction on it.

Dr. Fuhrman, several of your colleagues in last year’s panel discussion expressed the desire to see the IVD industry come up with devices that were more self-cleansing, a little more automated for their sterilization and so on. I would assume you’d enjoy seeing an advance like that in some of the testing devices.
Dr. Fuhrman (OhioHealth): Yes, I would. I was talking with my team the other day, and I said, “Wouldn’t it be nice if we could somehow use the kind of UV cleaners they now have for cellphones?” That’s in addition to the wiping. You could stick them on a shelf. They’d all go to the same place. You’d press the button and they’d get a quick, deep UV clean. It wouldn’t be a substitute for cleaning; it would be an adjunct.

The technology is there. I suppose the UV light might not do wonderful things to the plastic of the devices. I will refer to the manufacturers present to see what they think of that idea.

Todd Cullen (Arkray): There is a device out there that we have seen. It was presented to Arkray in a long-term care facility, and it’s basically that. It’s a UV light. It’s like a toaster oven, and you can put all of your devices in there and it basically cleans and disinfects and is kind to those devices. Ultraviolet light doesn’t cause a lot of damage to the devices.

The challenge we have as a manufacturer is validating that it kills all of the viruses and bacteria you’re looking for, and then you’ve got to submit that to the FDA as a proper disinfecting process. So it’s expensive and time-consuming. It took upward of a year for a 510(k) to do that, to validate that product. And if you update your product you’ve got to redo that every time. So it can be a challenge. It’s a smart idea, a valid idea, but there are regulatory concerns that in some cases would prohibit it.

Dr. Fuhrman (OhioHealth): I was thinking the same thing, that it would be difficult to make a claim that it could take the place of cleaning. So I was thinking you wouldn’t make that claim, but you would be able to say to folks, “This is going to be better.” It’s just an easier claim to say “better” than the other claim. But I see where you’re coming from and it is a shame and an example of how we are sometimes not encouraged to do things we would otherwise do.

Dr. Fantz (Roche): The wipes go through a similar process—the instrument you use and the wipes you use to clean it all get approved by the FDA. So there are a limited number of brands of wipes you can use for a certain instrument.

Dr. Fuhrman (OhioHealth): Do the wipes we use have an expiration date? If so, how do we manage that?

Dr. Fantz (Roche): Roche isn’t a wipe manufacturer, so I don’t know the answer, but I’m guessing there is an expiration date on the bottle. I was focusing on the brands of wipes that are used for a certain instrument. Those have to go through clearance and require a huge number of testing cycles. So it’s expensive to test and validate new cleaning systems, whether it’s a wipe or UV light or whatever you’re going to use for your instrument, and it’s tied to that particular instrument so any changes or updates would have to be revalidated.

The other piece of this that gets transferred is the strip. If you’re sticking your finger—a bloody finger from a previous contaminated patient—into the vial of strips, that’s another source of contamination that’s difficult to control. And we’ve looked at other strip distribution devices, and they’re also expensive and sometimes difficult to work with. But it is something we think about.

In the January 2020 issue of CAP TODAY, David Sacks [MD, PhD, of the NIH], who is an expert in this area, talked about the possibility that the trial reported in 2009 that found an increase in mortality with tight glycemic control may have been affected by the quality of the glucose measurements, though it can’t be known because there’s no information about the analytical performance of those methods, and that tight glycemic control therefore could have value as was found in the original van den Berghe trial, published in 2001. What are your thoughts on the state of tight glycemic control today?

Dr. Fantz (Roche): I think it is worthy. We have a retrospective lens on those studies, and maybe they could have been done a little better. What people realized is that spiking glucose in hospitalized patients isn’t good and they’ve been trying to control it better, though maybe not as tight as the original studies indicated. But as we understand that better and the precision of the instruments gets better, those studies can improve with the data we’re generating. It deserves a re-look, and I would support Dr. Sacks’ opinion on that.

Dr. Fuhrman (OhioHealth): It’s not my area of expertise, but I would definitely trust David. This is what he does and he’s world renowned for it. One of the things I was interested in, and I’m not a student of this area, is that with the continuous glucose monitors and the insulin pumps, patients were believed to be perfectly controlled—that was the concept. I don’t know if we have enough data on those perfectly controlled patients, but I would think that would be the gold standard, if and when the data become available.

Todd and Dr. Fantz, do you have any thoughts, questions, or issues you’d like to raise in closing?
Todd Cullen (Arkray): From an industry perspective, we’re trying to support our customers in managing the entire diabetes disease state, not just blood glucose monitoring. What we’ve seen more and more from our customers, what they’re requesting, is from a holistic perspective, how can we surround that particular patient and support their disease management, not just by measuring blood sugar? That is, how are we supporting them from a population health perspective, wellness, and all of those aspects of managing the person’s diabetes—keep them in control, provide better outcomes at a reduced cost, and prevent or minimize the risks for some of the comorbidities? So we as an industry—and this is where Arkray’s focus is—should be looking at more than in vitro diagnostic testing. It’s the holistic view that is needed.

Dr. Fantz (Roche): It’s an exciting time in glucose management. A lot of new technologies are coming for inpatients and outpatients, and with those technologies we will be able to do what Todd raises: population management for the patients and helping improve their lives. I’d also say that as a manufacturer we need to help health systems manage those populations by making the workflows of the point-of-care coordinators and laboratory staff easier on a daily basis.

Dr. Fuhrman, do you have thoughts about how manufacturers can help your health system do an improved job in this area?
Dr. Fuhrman (OhioHealth): Corinne is right on with the workflow. When I look at what we’re doing for blood glucose monitoring and where we have issues and where we see gaps, it has to do with that workflow and understanding exactly what the nurses are doing, what their constraints are, how integrated their workflow is to whatever electronic medical record they’re using, because they’re doing the vast majority of that work in that record. So the more integrated the manufacturers can be and the better we deal with that data and the better those systems talk to each other and the more flexible they can be, that will help things on the hospital side.

On the industry side, I agree with Todd. When you take a big step back to the big picture, the issue is we need to get these patients diagnosed faster and we need to have a societal way of handling them, following up, making sure they’re not lost to follow-up, making sure their medications are available and that they have access. We need to get the costs down—we can’t have the patients have that burden because if they don’t deal with the disease sooner rather than later, it will be much more expensive. And that’s an issue that we as a society have to get our arms around.