Restrospective Study Finds That Masimo SET® Pulse Oximetry Has No Difference in Accuracy or Bias Between Black People and White People
January 17 2022 - 1:22PM
Business Wire
Masimo (NASDAQ: MASI) today announced the findings of an
abstract presented last Saturday at the Society for Technology in
Anesthesia 2022 Annual Meeting, which reviewed retrospective pulse
oximetry data and concluded that there was no clinically
significant bias based on ethnicity for black and white volunteer
subjects monitored with Masimo SET® pulse oximetry and RD SET®
sensors.1
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Masimo SET® Pulse Oximetry with RD SET®
Sensors (Photo: Business Wire)
A 2020 letter to the editor2 and paper3 purported to find
“racial bias” in pulse oximetry measurements, based upon a
comparison of data obtained from black and white patients compiled
from multiple sets of health record data, using unspecified pulse
oximeters and controls. Masimo Founder and CEO Joe Kiani responded
to the letter and promised additional research to test Masimo’s
understanding of the subject and hypothesis about the performance
of Masimo technology. The first of such studies was conducted and
reported by Dr. Steven J. Barker (Chief Science Officer, Masimo)
and Dr. William C. Wilson (Chief Medical Officer, Masimo). Drs.
Barker and Wilson performed a retrospective analysis of Masimo
laboratory data obtained from black and white volunteer subjects,
in an effort to identify differences in Masimo pulse oximeter
accuracy and bias between ethnic groups.
The authors reviewed data collected between October 2015 and
July 2021, which included 7,183 paired samples (3,201 black and
3,982 white) collected from 75 subjects (39 black and 36 white),
who were screened with the same criteria to remove potential bias
based on health conditions. All subjects were exposed to the same
hypoxia protocol, which varied the arterial saturation of
hemoglobin (SaO2) between 70% and 100%. Noninvasive oxygen
saturation (SpO2) values were obtained from Masimo SET® pulse
oximeters with RD SET sensors and time-matched (within 5 seconds,
rather than up to 10 minutes as in the letter to the editor) with
arterial blood gas (ABG) samples analyzed using an ABL-835 blood
gas analyzer.
The authors analyzed the data to determine the bias (the mean
difference in paired SpO2 and SaO2 samples), precision (standard
deviation of the difference), and accuracy (root mean squared
error, ARMS*) for both groups. They found a negative bias of 0.20%
for black subjects, compared to a negative bias of 0.05% for white
subjects, a difference of 0.15% (p < 0.001), which is not
clinically significant and is numerically indistinguishable because
the SpO2 display resolution is 1% on commercially available pulse
oximeters (both from Masimo and other manufacturers). They found
precision of 1.40% for black subjects and 1.35% for white subjects.
Accuracy (ARMS) was 1.42% for black subjects and 1.35% for white
subjects. These results are consistent with the accuracy
specifications of RD SET sensors (1.5% accuracy ARMS).
By comparison to the Masimo finding of 0.15% difference in bias
between black and white subjects, the 2020 letter to the editor
reported a difference in bias of 8.1% in a cohort of black and
white hospital patients2 – 54 times higher than the Masimo
result.
Masimo is conducting additional studies and will report its
findings in the future.
@Masimo | #Masimo
*ARMS accuracy is a statistical calculation of the difference
between device measurements and reference measurements.
Approximately two-thirds of the device measurements fell within +/-
ARMS of the reference measurements in a controlled study.
About Masimo
Masimo (NASDAQ: MASI) is a global medical technology company
that develops and produces a wide array of industry-leading
monitoring technologies, including innovative measurements,
sensors, patient monitors, and automation and connectivity
solutions. Our mission is to improve patient outcomes and reduce
the cost of care. Masimo SET® Measure-through Motion and Low
Perfusion™ pulse oximetry, introduced in 1995, has been shown in
over 100 independent and objective studies to outperform other
pulse oximetry technologies.4 Masimo SET® has also been shown to
help clinicians reduce severe retinopathy of prematurity in
neonates,5 improve CCHD screening in newborns,6 and, when used for
continuous monitoring with Masimo Patient SafetyNet™ in
post-surgical wards, reduce rapid response team activations, ICU
transfers, and costs.7-10 Masimo SET® is estimated to be used on
more than 200 million patients in leading hospitals and other
healthcare settings around the world,11 and is the primary pulse
oximetry at 9 of the top 10 hospitals as ranked in the 2021-22 U.S.
News and World Report Best Hospitals Honor Roll.12 Masimo continues
to refine SET® and in 2018, announced that SpO2 accuracy on RD SET®
sensors during conditions of motion has been significantly
improved, providing clinicians with even greater confidence that
the SpO2 values they rely on accurately reflect a patient’s
physiological status. In 2005, Masimo introduced rainbow® Pulse
CO-Oximetry technology, allowing noninvasive and continuous
monitoring of blood constituents that previously could only be
measured invasively, including total hemoglobin (SpHb®), oxygen
content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®),
Pleth Variability Index (PVi®), RPVi™ (rainbow® PVi), and Oxygen
Reserve Index (ORi™). In 2013, Masimo introduced the Root® Patient
Monitoring and Connectivity Platform, built from the ground up to
be as flexible and expandable as possible to facilitate the
addition of other Masimo and third-party monitoring technologies;
key Masimo additions include Next Generation SedLine® Brain
Function Monitoring, O3® Regional Oximetry, and ISA™ Capnography
with NomoLine® sampling lines. Masimo’s family of continuous and
spot-check monitoring Pulse CO-Oximeters® includes devices designed
for use in a variety of clinical and non-clinical scenarios,
including tetherless, wearable technology, such as Radius-7® and
Radius PPG™, portable devices like Rad-67®, fingertip pulse
oximeters like MightySat® Rx, and devices available for use both in
the hospital and at home, such as Rad-97®. Masimo hospital
automation and connectivity solutions are centered around the
Masimo Hospital Automation™ platform, and include Iris® Gateway,
iSirona™, Patient SafetyNet, Replica®, Halo ION™, UniView®, UniView
:60™, and Masimo SafetyNet®. Additional information about Masimo
and its products may be found at www.masimo.com. Published clinical
studies on Masimo products can be found at
www.masimo.com/evidence/featured-studies/feature/.
ORi and RPVi have not received FDA 510(k) clearance and are not
available for sale in the United States. The use of the trademark
Patient SafetyNet is under license from University HealthSystem
Consortium.
References
- Barker SJ, Wilson WC. Accuracy of Masimo SET® Pulse Oximetry in
Black and White Volunteer Subjects: A Retrospective Review. Annual
Meeting of the Society of Technology in Anesthesiology. Presented
Jan 15, 2022.
- Sjoding MW, et al: Racial Bias in Pulse Oximetry Measurement N
Engl J Med 2020; 383 (25):2477-2478.
- Valbuena VSM, et al: Racial Bias in Pulse Oximetry Measurement
Among Patients About to Undergo ECMO in 2019-2020, A retrospective
Cohort Study. Chest 2021 Sep 27; S0012-3692(21)04065-4.
- Published clinical studies on pulse oximetry and the benefits
of Masimo SET® can be found on our website at
http://www.masimo.com. Comparative studies include independent and
objective studies which are comprised of abstracts presented at
scientific meetings and peer-reviewed journal articles.
- Castillo A et al. Prevention of Retinopathy of Prematurity in
Preterm Infants through Changes in Clinical Practice and SpO2
Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
- de-Wahl Granelli A et al. Impact of pulse oximetry screening on
the detection of duct dependent congenital heart disease: a Swedish
prospective screening study in 39,821 newborns. BMJ. 2009;Jan
8;338.
- Taenzer A et al. Impact of pulse oximetry surveillance on
rescue events and intensive care unit transfers: a before-and-after
concurrence study. Anesthesiology. 2010:112(2):282-287.
- Taenzer A et al. Postoperative Monitoring – The Dartmouth
Experience. Anesthesia Patient Safety Foundation Newsletter.
Spring-Summer 2012.
- McGrath S et al. Surveillance Monitoring Management for General
Care Units: Strategy, Design, and Implementation. The Joint
Commission Journal on Quality and Patient Safety. 2016
Jul;42(7):293-302.
- McGrath S et al. Inpatient Respiratory Arrest Associated With
Sedative and Analgesic Medications: Impact of Continuous Monitoring
on Patient Mortality and Severe Morbidity. J Patient Saf. 2020 14
Mar. DOI: 10.1097/PTS.0000000000000696.
- Estimate: Masimo data on file.
-
http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.
Forward-Looking Statements
This press release includes forward-looking statements as
defined in Section 27A of the Securities Act of 1933 and Section
21E of the Securities Exchange Act of 1934, in connection with the
Private Securities Litigation Reform Act of 1995. These
forward-looking statements include, among others, statements
regarding the potential effectiveness of Masimo SET® and RD SET®,
and Masimo’s plan to conduct additional studies on the accuracy of
Masimo SET® and RD SET on black people and white people
(“Additional Studies”). These forward-looking statements are based
on current expectations about future events affecting us and are
subject to risks and uncertainties, all of which are difficult to
predict and many of which are beyond our control and could cause
our actual results to differ materially and adversely from those
expressed in our forward-looking statements as a result of various
risk factors, including, but not limited to: risks related to our
assumptions regarding the repeatability of clinical results; risks
related to our belief that Masimo's unique noninvasive measurement
technologies, including SET® and RD SET, contribute to positive
clinical outcomes and patient safety; risks that Masimo fails to
conduct Additional Studies as planned; risks that the researchers’
conclusions and findings may be inaccurate; risks related to our
belief that Masimo noninvasive medical breakthroughs provide
cost-effective solutions and unique advantages; risks related to
COVID-19; as well as other factors discussed in the "Risk Factors"
section of our most recent reports filed with the Securities and
Exchange Commission ("SEC"), which may be obtained for free at the
SEC's website at www.sec.gov. Although we believe that the
expectations reflected in our forward-looking statements are
reasonable, we do not know whether our expectations will prove
correct. All forward-looking statements included in this press
release are expressly qualified in their entirety by the foregoing
cautionary statements. You are cautioned not to place undue
reliance on these forward-looking statements, which speak only as
of today's date. We do not undertake any obligation to update,
amend or clarify these statements or the "Risk Factors" contained
in our most recent reports filed with the SEC, whether as a result
of new information, future events or otherwise, except as may be
required under the applicable securities laws.
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Media Contact: Masimo Evan Lamb 949-396-3376
elamb@masimo.com
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