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Pulse oximeter performance and skin pigment: comparison of 34 oximeters using current and emerging regulatory frameworks

2025-08-13 anesthesia Title + abstract only
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BackgroundThe International Organization for Standardization (ISO) and US Food and Drug Administration (FDA) are updating regulations for pulse oximeters to reduce performance disparities linked to skin pigment. We tested common oximeters with current and anticipated regulatory frameworks. We hypothesized that not all oximeters show more positive bias in darkly vs lightly pigmented participants and that few oximeters would pass the anticipated FDA regulations. MethodsWe used a controlled desat...

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