Pulse oximeters, which measure the saturation of oxygen in blood, were invented in 1974. In the decades since, numerous studies have found they have more inaccurate readings on darker skin tones compared to lighter ones. During the pandemic, incorrect readings for Black, Hispanic and Asian COVID-19 patients might have resulted in delayed or no treatment, according to one study.
In February, the FDA convened a panel of experts to dive into the issue and offer recommendations for those conducting premarket studies.
In the proposed guidance released Jan. 6, the agency recommends pulse oximeter manufacturers analyze clinical data on device performance across several skin pigmentations. The guidance also suggests they increase the number of clinical trial participants, use objective and subjective methods to evaluate a participant’s skin tone and, if proved, include a label on the device highlighting its accuracy across several skin pigmentations.
The FDA is seeking comment on the guidance within the next 60 days, after which it will publish its final recommendations.
