Pulse oximeters overestimate O2 saturations in darker-skin patients; FDA acts (again)
PulmCCM
JANUARY 15, 2025
Pulse oximeters for healthcare and consumer use are calibrated on patients with lighter skin. Manufacturers have recognized the devices’ suboptimal performance in darker-skinned patients for decades, but they have faced no serious regulatory or legal pressure to act. In 2013, FDA issued a suggestion that manufacturers test devices on patients “with a range of skin pigmentations.” But the standard was lax: only two darkly pigmented subjects, or 15% of the total pool were needed.
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