The FDA is convening a panel of experts to determine a better way to evaluate pulse oximeter readings so that they provide more accurate data for patients of color, the agency announced Feb. 2.
Pulse oximeters were invented in 1974 and decades of research since then have repeatedly shown inaccuracies in readings for individuals with darker skin tones.
A 2022 study of 3,029 patients, led by experts from Boston-based Harvard Medical School and Massachusetts General Hospital, found that "Asian, Black, and Hispanic patients in the ICU received less supplemental oxygen than White patients, and this finding was associated with differences in pulse oximeter performance," which they note "may contribute to racial and ethnic disparities in care."
The new FDA panel will explore "an approach to improve the quality of premarket studies and associated methods used to evaluate the performance of pulse oximeters submitted for premarket review, taking into consideration a patient’s skin pigmentation, and patient-reported race and ethnicity," the meeting notes state.
The panel will also begin to discuss what type of data and how manufacturers should present that information to the FDA for evaluation of the devices going forward.
"I will admit, as an anesthesiologist, I and many of my medical colleagues were minimally aware of this discrepancy," Dionne Ibekie, MD, an anesthesiologist in central Illinois told CNN. "It wasn’t something really emphasized in training or medical school. So I was shocked, but not surprised, to learn about this pulse ox discrepancy."
The Feb. 2 discussion was open to the public, and a document for external feedback is available for providing commentary to the panel.