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From the beloved media brand 24x7 comes the HTM 24x7 podcast, which delves into the ever-evolving landscape of healthcare technology management. Join us on a journey to understand how cutting-edge technology is shaping the healthcare industry, improving patient care, and ensuring the secure and efficient management of medical systems in a digital age. From electronic health records to telemedicine, cybersecurity to innovative medical devices, we’ll bring you expert insights, real-world stories, and discussions that shed light on how technology is revolutionizing healthcare delivery. Whether you’re a seasoned biomed or mulling a career in healthcare technology management, this podcast is your go-to source for insights and discussions on the future of HTM.
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.