FDA issues alert on ‘limitations’ of pulse oximeters, without explicit mention of racial bias

Two months after Democratic lawmakers expressed concern about potential racial disparities in pulse oximeter readings — calling the issue a matter of “life or death” — the Food and Drug Administration on Friday issued a public warning about the devices, acknowledging they had “limitations.”

The alert comes decades after researchers first identified potential inaccuracies with the devices when used on people of color and months after a series of new studies produced fresh data underlining the problem. Most recently, researchers at the University of Michigan published a December 2020 letter in the New England Journal of Medicine that found oximeters were nearly three times as likely to miss hypoxemia in Black patients compared with white patients.

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