After attorney general push, FDA targets pulse oximeters

Two weeks after 25 attorneys general urged the FDA to investigate inaccuracies of pulse oximeters when used on people with darker skin, the agency scheduled a medical devices committee meeting to evaluate the issue. 

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A consensus has been growing about the inequitable readings of pulse oximeters, which measure blood oxygen levels, and the FDA discussed the matter in November 2022. The agency has been working to test the accuracy of pulse oximeters in diverse populations, but the attorneys general letter said pulse oximeters still lack clear warning labels.

The second meeting, marked for Feb. 2, will center on improving study methods that account for patients’ skin pigmentation, race and ethnicity.

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