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. 2022 Feb;67(2):252-257.
doi: 10.4187/respcare.09795. Epub 2021 Nov 12.

Pulse Oximeter Performance, Racial Inequity, and the Work Ahead

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Free article

Pulse Oximeter Performance, Racial Inequity, and the Work Ahead

Olubunmi E Okunlola et al. Respir Care. 2022 Feb.
Free article

Abstract

It has long been known that many pulse oximeters function less accurately in patients with darker skin. Reasons for this observation are incompletely characterized and potentially enabled by limitations in existing regulatory oversight. Based on decades of experience and unpublished data, we believe it is feasible to fully characterize, in the public domain, the factors that contribute to missing clinically important hypoxemia in patients with darkly pigmented skin. Here we propose 5 priority areas of inquiry for the research community and actionable changes to current regulations that will help improve oximeter accuracy. We propose that leading regulatory agencies should immediately modify standards for measuring accuracy and precision of oximeter performance, analyzing and reporting performance outliers, diversifying study subject pools, thoughtfully defining skin pigmentation, reporting data transparently, and accounting for performance during low-perfusion states. These changes will help reduce bias in pulse oximeter performance and improve access to safe oximeters.

Keywords: medical device; oxygen saturation; pulse oximeter; racial bias.

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Conflict of interest statement

The UCSF Hypoxia Research Laboratory, Clinimark, and Physio Monitor, LLC charge pulse oximeter manufacturers for performing validation studies, but no companies were involved with the writing or data analysis presented in this paper.

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