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FDA advisory panel reviewing pulse oximeter accuracy with dark skin

A Food and Drug Administration advisory panel met Friday to talk about how to make these important medical devices more accurate for all patients.
FDA advisory panel reviewing pulse oximeter accuracy with dark skin
Posted at 2:39 PM, Feb 02, 2024
and last updated 2024-02-02 17:35:27-05

The accuracy of pulse oximeters for people with dark skin tones is now being reviewed. 

An FDA advisory panel met Friday to talk about how to make these devices more accurate for people with darker pigmentation.

Pulse oximeters send light beams through your finger to evaluate your pulse rate and the oxygen saturation of your blood.

Research has shown that darker pigmentation can affect how light is absorbed by the sensors, which can lead to inaccurate results.

Inaccuracies could then lead to delayed care or missed diagnoses.

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.”

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Discussions on the device's accuracy came to light during the pandemic, when more people were using the devices.

The FDA issued a formal warning about pulse oximeters in February 2021, citing limitations and risks of inaccuracy.

In the release, the FDA said in part: “The U.S. Food and Drug Administration (FDA) is informing patients and health care providers that although pulse oximetry is useful for estimating blood oxygen levels, pulse oximeters have limitations and a risk of inaccuracy under certain circumstances that should be considered. Patients with conditions such as COVID-19 who monitor their condition at home should pay attention to all signs and symptoms of their condition and communicate any concerns to their health care provider.”

@scrippsnews FDA advisory panel debates inaccuracy of pulse oximeters for people with dark skin tones, which became a hot topic during the pandemic. #health ♬ original sound - Scripps News


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