ArticlemedRxiv : the preprint server for health sciences2025
Pulse oximeter performance and skin pigment: comparison of 34 oximeters using current and emerging regulatory frameworks.
Article in medRxiv : the preprint server for health sciences, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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24 authors.
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Abstract
Background: The 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. Methods: We used a controlled desaturation protocol to test 34 oximeters across arterial oxygen saturations (SaO Results: For cohorts of 24 participants, 28/34 oximeters passed 2017 ISO Standard (A Conclusions: Pulse oximeters show variable performance across manufacturers and models. Notably, only some devices show more positive bias in people with darker skin. Anticipated updates to ISO and FDA frameworks yield strikingly different assessments and require refinement of cohort sizes and differential bias criteria. Whether new guidelines will translate into improved real-world performance or reduced health disparities is yet to be determined.
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