Evidence map›Paper›PMID 42012940›Full record

ArticleAnesthesia and analgesia2026

Pulse Oximeter Performance and Skin Pigment: Comparison of 34 Oximeters Using Current and Emerging Regulatory Frameworks.

Caroline Hughes, Danni Chen, Tyler Law, Philip Bickler, John Feiner, Leonid Shmuylovich, Ella Behnke, Lily Ortiz, Gregory Leeb, René Vargas Zamora and 3 more

Abstract read
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In one paragraph

Article in Anesthesia and analgesia, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors.

Caroline HughesFrom the Department of Anesthesia, University of California San Francisco Hypoxia Research Laboratory, San Francisco, CA.
Danni ChenFrom the Department of Anesthesia, University of California San Francisco Hypoxia Research Laboratory, San Francisco, CA.
Tyler LawFrom the Department of Anesthesia, University of California San Francisco Hypoxia Research Laboratory, San Francisco, CA.
Philip BicklerFrom the Department of Anesthesia, University of California San Francisco Hypoxia Research Laboratory, San Francisco, CA.ORCID 0000-0002-5077-4982
John FeinerFrom the Department of Anesthesia, University of California San Francisco Hypoxia Research Laboratory, San Francisco, CA.ORCID 0000-0001-6161-1209
Leonid ShmuylovichDivision of Dermatology, Department of Medicine, Washington University in Saint Louis, St. Louis, MO.ORCID 0000-0001-9210-7873
Ella BehnkeFrom the Department of Anesthesia, University of California San Francisco Hypoxia Research Laboratory, San Francisco, CA.
Lily OrtizFrom the Department of Anesthesia, University of California San Francisco Hypoxia Research Laboratory, San Francisco, CA.
Gregory LeebFrom the Department of Anesthesia, University of California San Francisco Hypoxia Research Laboratory, San Francisco, CA.
René Vargas ZamoraFrom the Department of Anesthesia, University of California San Francisco Hypoxia Research Laboratory, San Francisco, CA.
Ellis MonkDepartment of Sociology, Harvard University, Boston, MA.
Michael S LipnickFrom the Department of Anesthesia, University of California San Francisco Hypoxia Research Laboratory, San Francisco, CA.ORCID 0000-0001-9978-1465
Collaborators

Funding

PATH/UNITAID
6 · The paper itself

Abstract

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 desaturation protocol to test 34 oximeters across arterial oxygen saturations (SaO2) 70% to 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 subjective Monk Skin Tone (MST) scale and the objective individual typology angle (ITA) derived from a spectrophotometer to characterize skin pigment. The accuracy root mean square error (ARMS), bias (mean of SpO2 - SaO2 error), and skin pigment differential bias were calculated. Monte Carlo simulation explored potential impacts of participant selection on device passing.

resultsFor cohorts of 24 participants, 28/34 oximeters (82%) passed 2017 ISO Standard (ARMS < 4%), 22/34 (65%) passed 2013 FDA guidance (ARMS ≤ 3%), 21/34 (62%) oximeters passed both ARMS and differential bias criteria for anticipated ISO standards, and 1/34 (3%) passed anticipated FDA criteria. More devices passed when testing cohorts were increased beyond 24 participants. Eleven oximeters had more positive bias in participants with dark vs light (dorsal finger) pigmentation across 70% to 100% SaO2 (median difference 1.42, IQR: 1.35-1.90). Eighteen devices could pass or fail depending on cohorts selected for analysis.

conclusionsPulse 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.

Identifiers

PMID42012940

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.