Restrospective Study Finds That Masimo SET Pulse Oximetry Has No Difference in Accuracy or Bias Between Black People and White People - Seite 2

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, A_RMS*) 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 (A_RMS) 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 A_RMS).

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

*A_RMS accuracy is a statistical calculation of the difference between device measurements and reference measurements. Approximately two-thirds of the device measurements fell within +/- A_RMS 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/.