Racial effects on Masimo pulse oximetry: a laboratory study.

Area of Science:

• Medical Devices
• Physiological Monitoring
• Biomedical Engineering

Background:

• Recent studies indicate potential inaccuracies in pulse oximetry for dark-skinned individuals during hypoxemia.
• Masimo SET® (Signal Extraction Technology®) was developed and validated to minimize skin pigmentation-related differences in pulse oximetry saturation (SpO2) and arterial oxygen saturation (SaO2).

Purpose of the Study:

• To investigate the accuracy of Masimo RD SET® sensors in healthy Black and White volunteers during induced hypoxemia.
• To compare the performance of Masimo RD SET® pulse oximetry between different skin pigmentation groups.

Main Methods:

• A retrospective analysis was conducted on 75 healthy Black and White volunteers.
• Subjects underwent a desaturation protocol, lowering SaO2 from 100% to 70%.
• Simultaneous SpO2 values were recorded using Masimo RD SET® sensors, and statistical bias and precision were calculated.

Main Results:

• Bias and precision were comparable between Black (-0.20 ± 1.40%) and White (-0.05 ± 1.35%) subjects.
• No significant visible differences in SpO2 vs. SaO2 plots were observed between races across the 70-100% saturation range.
• Occult hypoxemia occurred in 0.2% of White subjects but not in any Black subjects.

Conclusions:

• Masimo RD SET® pulse oximetry shows no clinically significant differences in accuracy between healthy Black and White subjects.
• The technology can be used with equal assurance in individuals with dark or light skin.
• These findings, from controlled laboratory conditions, suggest reliable performance across diverse skin pigmentation.