Study finds Masimo pulse oximetry accurate across skin tones

Masimo has released findings from a study examining its pulse oximetry technology across various skin tones. Dr. Vikrant Sharma, Dr. Steven Barker, Dr. William C. Wilson, and colleagues at Masimo conducted a focused analysis of previously published data assessing the impact of low perfusion on the performance of Masimo SET pulse oximetry across different skin tones. Their retrospective, peer-reviewed study was published in the Journal of Clinical Monitoring and Computing.

The analysis revealed accurate oxygen saturation (SpO2) measurements with Masimo RD SET sensors for both Black and White subjects with normal and low perfusion index (Pi). Masimo noted that this study contributes to the body of evidence supporting the accuracy of its pulse oximetry across various skin tones, showing no clinically significant difference in accuracy or bias, even under challenging conditions.

This data supplements existing clinical evidence supporting Masimo's pulse oximetry technology. In November 2022, Masimo reported that its technology exhibited consistent accuracy across different skin colors. The FDA had previously increased scrutiny on whether certain pulse oximeters might be less accurate for individuals with darker skin, prompting Democratic U.S. senators to urge further investigation by the agency.

Barker and Wilson analyzed laboratory data from self-identified Black and White volunteer subjects, examining differences in pulse oximetry accuracy and bias based on skin tone. They reviewed over 7,000 paired data samples collected from 75 subjects (39 Black and 36 White) between 2015 and 2021, finding no clinically significant differences in accuracy or bias.

Following the analysis, their conclusion was:

“Masimo SET pulse oximeters with RD SET sensors are accurate for individuals of both Black and White races when Pi is normal, as well as during conditions when Pi is low. The ARMS for all conditions studied is well within FDA standards. This study was conducted in healthy volunteers during well-controlled laboratory desaturations, and results could vary under certain challenging clinical conditions.”

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