Pulse Oximeters and Violation of Federal Antidiscrimination Law

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JAMA Network




On November 1, 2022, the US Food and Drug Administration (FDA) convened a panel of its Medical Device Advisory Committee to discuss a long-known flaw in clinical pulse oximeters: that darker-skinned patients, compared with lighter-skinned patients, are more likely to have falsely elevated oxygen saturation when measured with pulse oximetry, masking hypoxemia otherwise detected with arterial blood gas tests.1-3 The phenomenon, referred to as “occult hypoxemia,” has been associated with various disparities in health care outcomes, including higher in-hospital mortality and delayed or unrecognized eligibility for needed COVID-19 treatments.

Despite their accuracy limitations, currently marketed oximeters are compliant with FDA regulations. Regrettably, this means the enforcement tools, such as seizure and recall, typically available to the FDA during postmarket device surveillance, are limited. The FDA can and did issue a safety guidance last year, warning clinicians about the research on occult hypoxemia and encouraging them to make “bedside adjustments” to account for skin tone.4 The November 2022 meeting appears to be the first public action since that time and the first time experts have gathered publicly to discuss the issue.

That pulse oximeters have been used in clinical settings for nearly 40 years with little assurance of equitable performance across skin tones is distressing. Concerning still is that law has been unable to detect or deter any subsequent patient harm, the extent of which is likely unknowable. This Viewpoint discusses how biased oximeters have remained in use for decades without legal or regulatory action and why a recently proposed rule by the Department of Health and Human Services (HHS) may finally facilitate change.

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