Pulse oximeters, a device used to measure oxygen in the blood, could get a life-saving upgrade. The Food and Drug Administration proposed new guidance for the devices to improve their accuracy across different skin pigmentations.
Scientific evidence shows a disparity in performance between individuals with lighter and darker skin colors. The agency already warns health care workers that pulse oximeters have limitations leading to inaccurate readings.
Pulse oximeters send light beams through your finger to evaluate your pulse rate and the oxygen saturation of your blood.
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A report published in the New England Journal of Medicine in 2020 found that, “Black patients had nearly three times the frequency of occult hypoxemia that was not detected by pulse oximetry as White patients.”
The FDA issued a formal warning about pulse oximeters in February 2021, citing limitations and risks of inaccuracy.
The new draft guidance asks manufacturers to improve clinical study designs and validations to specifically address performance on different skin colors for devices used in medical settings.
It doesn’t apply to over the counter wellness or sporting products that have not been evaluated by the FDA. Many fitness tracking watches, such as those made by Garmin and Coros, have pulse oximeters built in. The FDA's new guidance would not impact those devices.
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The agency is requesting comments on the new guidance for the next 60 days before the rules are finalized.
