Masimo today announced findings from a study evaluating its pulse oximetry technology across a variety of skin pigmentations.
Dr. Vikrant Sharma, Dr. Steven Barker, Dr. William C. Wilson and colleagues at Masimo performed a focused analysis of previously published data evaluating the impact of low perfusion on the performance of Masimo SET pulse oximetry across multiple skin pigmentations. They published their retrospective, peer-reviewed study in the Journal of Clinical Monitoring and Computing.
The analysis demonstrated accurate oxygen saturation (SpO2) measurements with Masimo RD SET sensors for both Black and White subjects with a normal perfusion index (Pi) and a low Pi. Masimo said it adds to the body of evidence supporting its pulse oximetry’s accuracy across the skin tone range. It saw no clinically significant difference in accuracy or bias, even in challenging conditions.
This data adds to a growing body of clinical evidence supporting the pulse oximetry technology. In November 2022, Masimo reported that its technology demonstrated no difference in accuracy for different skin colors. The FDA previously heightened its scrutiny around whether some pulse oximeters may prove less accurate among people with darker skin. Democratic U.S. senators previously called on the agency to study the issue more.
Barker and Wilson analyzed laboratory data obtained from self-identified Black and White volunteer subjects. They evaluated the differences in pulse oximetry accuracy and bias on the basis of skin tone. The doctors looked at more than 7,000 paired data samples collected from 75 subjects (39 Black and 36 White). These samples, collected between 2015 and 2021, showed no clinically significant difference in accuracy or bias.
Based on the analysis, they concluded:
“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.”
However, the authors noted that controlling conditions in the laboratory help “minimize confounders” present in clinical scenarios.