Pulse Oximeter Performance and Skin Pigment: Comparison of 34 Oximeters Using Current and Emerging Regulatory Frameworks
Authors' conclusion
Pulse oximeters show variable performance across manufacturers and models. Notably, only some devices show more positive bias in people with darker skin.
Study context
- Population
- Healthy adults, saturations (SaO2) 70% to 100%, cohorts ≥24 with ≥25% darkly pigmented34 oximeters
- Comparison
- 34 pulse oximeters tested against current and anticipated ISO and Food and Drug Administration (FDA) regulatory criteria, by skin pigment
- Outcome
- Oximeters passing regulatory criteria (ARMS, bias, skin pigment differential bias)
Methodological detailscontrolled desaturation protocol, Monte Carlo simulation
- Controlled desaturation protocol
- Monte Carlo simulation
Performance
As reported in the abstract
Oximeters passing regulatory criteria (cohorts of 24)
Passed 2017 ISO Standard (ARMS < 4%)
28 of 34
82%
Passed 2013 FDA guidance (ARMS ≤ 3%)
22 of 34
65%
Passed ARMS and differential bias criteria for anticipated ISO standards
21 of 34
62%
Passed anticipated FDA criteria
1 of 34
3%
Further findings
Device passing with larger testing cohorts
- More devices passed when testing cohorts were increased beyond 24 participants
Differential bias by skin pigment (dorsal finger), SaO2 70% to 100%
- Oximeters with more positive bias in dark vs light pigmentation
- 11
- Median difference in bias, dark vs light (IQR 1.35-1.90)
- 1.42
Pass/fail dependence on cohort selection
- Devices that could pass or fail depending on cohorts selected for analysis
- 18
- Monte Carlo simulation
Original publication
Pulse Oximeter Performance and Skin Pigment: Comparison of 34 Oximeters Using Current and Emerging Regulatory Frameworks. Anesth Analg. Published 20 April 2026. doi:10.
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