FDA issues draft guidance to improve accuracy of pulse oximeters for people with darker skin tones

The US Food and Drug Administration (FDA) has published draft guidance for manufacturers of pulse oximeters that offers recommendations for the clinical testing and labelling of these electronic medical devices.

Pulse oximeters are small finger-clamp devices that estimate how much oxygen is being carried in the blood. Available both over the counter and by prescription, they grew in popularity during the Covid-19 pandemic. But many studies have revealed that pulse oximeters can measure blood oxygen levels as higher than they actually are for people with dark skin.

One of the FDA's recommendations is to include “a diversely pigmented group of 150 or more healthy participants” in clinical studies of the devices, with at least 25% of participants falling within each skin color group on the system known as the Monk Skin Tone scale. Another is for manufacturers to “prominently display appropriate warnings” in the devices’ instructions, such as informing patients that “differences in skin pigmentation may cause differences in pulse oximeter sensor performance.”

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Source: CNN, 6 January 2024.