Peer-Reviewed Study Finds That Masimo SET® Pulse Oximetry Has No Clinically Significant Difference in Accuracy or Bias Between Black and White People
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Masimo SET® Pulse Oximetry with RD SET® Sensors (Photo: Business Wire)
For this newly published study
The data were analyzed to determine the bias (mean difference in paired SpO2 and SaO2 samples), precision (standard deviation of the difference), and accuracy (root mean squared error, ARMS*) for both groups. A negative bias of 0.20% was found for Black subjects, compared to 0.05% for White subjects. This difference of 0.15% (p < 0.001) is not clinically significant and the values are numerically indistinguishable because the SpO2 display resolution is 1% on commercially available pulse oximeters (both from Masimo and other manufacturers). The investigators also found a 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), which are twice as good as the current FDA clearance thresholds for medical-grade pulse oximeters (3.0% accuracy ARMS).
In discussing their findings, Drs. Barker and Wilson describe how Masimo SET® accounts for skin pigmentation when measuring SpO2. “The absence of racial bias, and highly accurate overall performance exhibited by Masimo SET® pulse oximetry can be logically explained by Masimo’s engineering design and testing paradigm. … Conventional pulse oximetry uses the standard red over infrared algorithm to provide SpO2, while Masimo SET® uses that conventional algorithm along with four additional signal processing engines that all run in parallel. These signal processing systems allow the distinction between arterial and venous signal during motion and low perfusion by identifying and isolating the non-arterial and venous noise SpO2 from the true arterial SpO2 components in the signal. These multiple signal processing engines work together to overcome limitations of each independent method. This advanced technique allows for a more accurate picture of the pulsatile (arterial) signal and significantly reduces the impact of static absorbers such as skin pigment, bone density, and tissue thickness (e.g., finger, toe, or earlobe). Finally, the Masimo SET® SpO2 algorithm is calibrated and then validated using nearly equal numbers of dark and light-skinned subjects.”
Drs. Barker and Wilson summarized, “In conclusion, this retrospective study of healthy human volunteers monitored with Masimo RD SET pulse oximeter sensors showed an absence of clinically significant differences in accuracy between Black and White subjects.” The authors suggested that additional prospective clinical studies should be conducted to validate their results in critically ill patients utilizing Masimo SET® pulse oximeters and those from other manufacturers.
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*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. In addition, Masimo Consumer Audio is home to eight legendary audio brands, including Bowers & Wilkins, Denon, Marantz, and Polk Audio. Our mission is to improve life, 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.2 Masimo SET® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,3 improve CCHD screening in newborns,4 and, when used for continuous monitoring with Masimo Patient SafetyNet™ in post-surgical wards, reduce rapid response team activations, ICU transfers, and costs.5-8 Masimo SET® is estimated to be used on more than 200 million patients in leading hospitals and other healthcare settings around the world,9 and is the primary pulse oximetry at 9 of the top 10 hospitals as ranked in the 2022-23
ORi, RPVi, and Radius VSM have not received FDA 510(k) clearance and are not available for sale in
References
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Barker SJ, Wilson WC. Racial effects on Masimo pulse oximetry: a laboratory study. J Clin Monit Comput.
12 Nov 2022 . https://doi.org/10.1007/s10877-022-00927-w. - 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.
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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 SETon 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
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Source: Masimo