Dive Brief:
- Data generated by Masimo’s pulse oximeter has found no significant differences in the results from Black and White people, according to a retrospective analysis.
- Amid increased concern about the potential racial bias of pulse oximeters, Masimo reviewed the data it collected on its SET device from 2015 to 2021.
- Masimo said the result reflects its use of four additional signal processing engines, which, when added to the conventional algorithm, reduce the impact of factors including skin pigmentation.
Dive Insight:
Since the start of the COVID-19 pandemic, the potential racial bias of pulse oximeters, which date back almost 20 years, has spurred concerns at the Food and Drug Administration. The trend reflects the publication of several studies that found pulse oximeters overestimate blood oxygen in Black people.
Writing in the Journal of Clinical Monitoring and Computing, executives at Masimo noted that “nearly all the recent reports” pool data from multiple pulse oximeter manufacturers, thereby “generalizing claims on pulse oximetry without respect to manufacturer, model, or sensor type.” The company reviewed data on its SET pulse oximeter to generate specific evidence about its technology.
The study looked at data on 75 subjects, 39 Black and 36 White. All subjects were exposed to a protocol that varied their oxygen saturation between 70% and 100%. Masimo captured data using its device and compared the results to the output of an ABL-835 blood gas analyzer.
The researchers found a negative bias of 0.20% for Black subjects and 0.05% for White subjects, resulting in a difference of 0.15%. Blood oxygen display resolution is 1% on SET and other devices, meaning the results are “numerically indistinguishable” and not clinically significant, according to the researchers. Masimo attributed the result to its signal processing systems.
