Health Affairs January 14, 2025
Eli Y. Adashi, Daniel P. O’Mahony, I. Glenn Cohen

On November 1, 2023, a contingent of 25 US state attorneys general wrote to the commissioner of the Food and Drug Administration (FDA) to encourage the agency “to act with urgency to address the inaccuracy of pulse oximetry when used on people with darker toned skin.” Pulse oximeters measure the amount of light that passes through the skin as a way to estimate how much oxygen is in a patient’s red blood cells. Melanin, which absorbs light that passes through the skin, can interfere with the pulse oximeter’s ability to accurately measure blood oxygen levels; inaccurate readings may contribute to misdiagnoses and worse clinical outcomes.

The state attorneys general made special note of the fact that their letter was...

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Topics: FDA, Govt Agencies, Medical Devices, States
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