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

ABSTRACT:

Background

The International Organization for Standardization (ISO) and US Food and Drug Administration (FDA) are updating standards and guidance for pulse oximeters to reduce performance disparities linked to skin pigment. We tested common oximeters with current and anticipated regulatory frameworks. We hypothesized that most oximeters would show more positive bias in darkly vs lightly pigmented participants and that fewer oximeters would 'pass' anticipated regulations.

Methods

We used a controlled desaturation protocol to test 34 oximeters across arterial oxygen saturations (SaO2) 70-100% in healthy adults. Based on what FDA and ISO had shared at the time of study design, we studied cohort sizes of > 24 with > 25% of participants being darkly pigmented. We used the subject

SUBMITTER: Hughes C 

PROVIDER: S-EPMC12363702 | biostudies-literature | 2025 Aug

REPOSITORIES: biostudies-literature