Fixing pulse oximeters requires federal might and possible legal action, researchers say

Work by device manufacturers to improve the performance of pulse oximeters on people with darker skin has progressed little since the Food and Drug Administration asked manufacturers in 2013 to voluntarily test the devices on more diverse skin tones, according to a study published Monday in JAMA. The study and a related editorial suggest clearer guidance, enforcement, and possibly legal action may be necessary to ensure the devices work well on all skin tones. 

The new research analyzed paperwork submitted for FDA approval to market a device for 767 oximeters that had been approved between 1978-2024 and had accessible information about performance testing. The authors found references to skin tone, pigmentation, or race  in 4% of the documents submitted before the FDA made its suggestion to diversify skin tone testing in 2013. That number rose to only 25% of submissions after the guidance was released — a number the authors said was still far too low and shows how little has been done to fix a problem — poorer performance on darker skinned patients — known for decades. 

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