Racial Disparities in Healthcare: Skin Tone and Pulse Oximeters

Keri Stephens
Hi, welcome to the HTM 24/7 podcast. I’m your host, Keri Stephens. For this episode, I’m joined by Dr. Scott Lucas, ECRI’s Vice President of device safety to talk about an issue that’s garnered a lot of headlines lately, racial equity and medical devices, particularly Scott is going to talk about pulse oximeters. Because ECRI experts say people, people with darker skin tones may receive less accurate information than their white counterparts. And it’s a subject we really want to delve into from a medical device standpoint. So Scott, thanks for joining me today.

Scott Lucas
Thank you. It’s great to be here. Appreciate your time.

Keri Stephens
Yeah, this is this is really an interesting subject. And to start, how do pulse oximeter’s accuracy vary based on skin tone, and what does this mean for patients? That’s a

Scott Lucas
great question. So I think it would help to understand possibly how pulse oximeter is work. And then we’ll get into the skin tone piece of this. And it’s very, very, basically a pulse oximeter, as you’re used to it with a probe on your finger or adhesive on your finger. It shines two beams of light by led through your tissue, and then a sensor on the other end picks up the light. So your oxygenated blood absorbs infrared light, deoxygenated blood absorbs the red light. And that ratio is then calculated as a pulse ox or blood saturation level. So ideally, it would be nice that we’d have nothing else absorbing the light. So we were just looking at the blood, whether it’s oxygenated or not. But in reality, we have bone and other tissue that’s absorbing some of that light. So it’s a little bit more difficult to comprehend. Now skin tone, if it’s darker, that also absorbs light. So what happens is potentially, you get a situation where you have a normal reading for pulse ox, when in fact, the actual blood oxygen saturation is a few percent less than that normal reading.

Keri Stephens
Okay, no, that makes sense. So what recommendations exists to make pulse oximeters more accurate for everyone?

Scott Lucas
Yes, good question. So and just to continue a little bit from the prior, I mean, if we have to think about it from clinical significance, right, so in most of the time, if a if a patient is adequately perfused, and adequately saturated, then a couple percentage of their variation isn’t that big of a deal, because it doesn’t require clinical intervention. The problem becomes when the pulse, the actual pulse ox may drop to like 88%, or something where clinical intervention is generally needed. In reality, the pulse ox will read something higher like 91% 92%, and then a clinical decision might not be made. So that’s one component of accuracy. And the broader component is how do Pulse ox is how do we you know, ensure their accuracy and I think of it from several different perspectives, you know, usability human factors, interoperability, the pulse ox very, I mean, a simple example should be that, it the probe needs to be tight on the finger or the ear lobe or the toe, and not move around, have motion artifact. Interoperability, the connections should be secure. If it’s a, you know, a standalone unit that’s different. But if it’s a has a console, or if it’s connected to a patient monitor, all those connections should be secure. The software’s associated with them should all be compatible. So pulse oximeters have alarms built in, and that should be compatible with the patient monitor that’s, that’s connected to. So it’s a system is a system approach to make sure everything’s playing and working together properly. There’s also more advancements, I mean, pulse ox has been around for many years, let’s say the modern technology even for decades, but now we’re getting more sophisticated. So it’s an which improves accuracy. So things like being able to identify noise and filter it out of the signal, or being able to account for poor perfusion and still give a appropriate saturation level. You know, things like that are now improvements. iteratively as the technology gets more mature, yeah.

Keri Stephens
You mentioned, you know, the technology obviously getting more sophisticated. So why do you think now the public has been more made more aware of the racial inequity and pulse oximeters?

Scott Lucas
Good question that, you know, it’s, this has been a kind of a known issue, at least anecdotally, for a long time. Like, if you talk to nurses in the field or clinicians They may anecdotally say, Oh yes, I was aware that if we had a patient with a darker skin tone, I just needed to be extra careful. pulse oximetry, by the way is always an adjunct and complement to care. It’s not the only diagnostic tool. So it’s always considered that way. But it’s been sort of a known issue. But, you know, I think recently, it’s risen because or escalated because of the pandemic. And you think about how prolific pulse oximeter is where at home, and people using pulse ox and he said, to get a saturation level and a temperature as a diagnostic tool to help determine if we had COVID or not, and talk to our provider. So there was all this, these issues, then around that. And then there’s some recent studies, too, that have shown have done this comparison to, you know, using pulse oximetry, from the device with actually a blood draw, and determine that there is a variability in a scientific method. So yes, it’s an issue. It’s been addressed, raised and addressed. And now the FDA is really focused on it.

Keri Stephens
Well, I also want to focus on what ECRI is doing, what exactly is ECRI doing to understand and improve pulse oximeter accuracy?

Scott Lucas
So like any medical device or patient safety issue, we take a comprehensive approach to that, you know, and that ranges from understanding what the market is, what the devices are out there doing market intelligence reports and things like that. doing clinical understanding clinical evidence, and clinical outcomes associated with the use of devices. And, and benchtop testing human factors, testing it through our device safety program. So we have engineers, clinicians, human factors, engineers, all looking at Pulse ox and other devices from a comprehensive approach, then post market to so we want to analyze and look at all the recalls of hazards and safety, communications, anything post market, we tried to grab and have reported to us through our patient safety organization, or straight from our users that that can help us understand all these issues. So we put it all together, come up with the best recommendations possible on safety with pulse ox and then any device and just publish it, send it out to our customers send it out to the public. Talk about it at the FDA, or any any kind of professional societies, any forum that shares our mission. You know, we want to share this information.

Keri Stephens
I want to get back to the FDA now. So what were the main points discussed in the FDA meeting about pulse oximeter performance? Can we delve into that a little more?

Scott Lucas
Sure. So in up until now, or I guess the last, let’s say 10 plus years, the guidance for development of pulse oximeter is included to have a patient population represented. But it was somewhat has been somewhat vague as far as how many people with different skin tones should be represented in that cohort. So it’s like two who was I think two patients or two patients who subjects should be of a darker skin tone. But that’s, that’s vague. What does that mean? So now, it’s more the recommendations from the FDA, which are out for public comment, and were being discussed in this meeting include increasing the number of subjects, and also having a more accurate representation of the patient population, included in the subjects that are used to help design that device. So it gets more specific that in that there are two methods proposed to test for skin tone in that cohort. And those are one of them’s called Monk Skin Tone, MST. So that’s a more comprehensive assessment of the different kinds of skin tones across the population, and more accurate. And it’s gotten the attention of nationals security, Google, using Google images, all these other broad platforms have recognized that this is a more up to date and more accurate representation of skin tones, especially in the darker continuum with skin tones. So that’s that’s what the FDA is discussing. And then basically how to do it, how to how to assess the skin tones how to use colorimeter devices and to quantify skin tone, you know, and how to go about that. So we’re having that we had a meeting meeting recently at the FDA with with multiple stakeholders, we were there. device manufacturers, were there, patient safety advocates, and it was really a good comprehensive meeting. And everybody was essentially in agreement that yes, this is a good idea. Now it’s how do we get it done? So that’s where we’re at now.

Keri Stephens
That’s interesting and helpful. So how can the lessons learned from pulse oximeter accuracy help address racial disparities in healthcare as a whole?

Scott Lucas
Yeah, that’s a that’s a great question. It’s, it’s so important. I think one thing that has come to light in this example is that the whatever the population that the device is intended to be used on should be represented in the design and development of the device. It should not the color of someone’s skin should have no impact on the quality of health care that they receive zero, it should all be the same. Yeah, so we have to that has to be represented in the design of the device, especially now you think about these are standalone devices, Pulse ox is right. Right, especially if you start thinking about artificial intelligence, and where we’re going with that the data that that technology is trained on should be representative of the of the patient population in which it’s deployed. So that’s it, I mean, we have to be accurate in the development of the device to better represent our patient population.

Keri Stephens
Great. So as a last question, our audience is the healthcare technology management profession. So what would you like to tell the members of the HTM profession about this, or just racial equity in general, and healthcare? Well,

Scott Lucas
I think that we love to hear from everyone for one and htm and in other venues about these types of issues. And I know that a lot of folks listening to this are our partners and customers. And so we love to hear from all stakeholders. So I mean, contact us with these issues, we’ll work to develop, you know, safety strategies and recommendations. And that could be individual to folks or just being able to publish broader on a broader scale to forums like the FDA, but I’d say just stay vigilant. I mean, it’s if a device shows up from a vendor and a facility then question it, you know, where, what’s the data? Where’s the data? What’s this device validated on? Is this appropriate for our patient population and have healthcare disparity front and center when when considering a big purchase? It’s important and we shouldn’t take it for granted.

Keri Stephens
Well, thank you so much, Scott. I mean, this was very informative to me and I know to our listeners as well, and to our listeners, thank you as well and be sure to visit www.24x7mag.com for the latest industry news and insights. Thank you again, take care.