FDA Proposes New Guidance To Address Pulse Oximeter Inaccuracies Due to Skin Tone

Federal regulators are calling for larger pulse oximeter clinical studies, to ensure manufacturers examine the accuracy of the devices on all skin tones.

Decades of research has indicated that pulse oximeters, which are medical devices placed on the fingertip to measure the amount of oxygen carried in the blood, often provide inaccurate readings for individuals with darker skin tones.

However, this issue gained widespread public attention during the COVID-19 pandemic when these devices became essential for monitoring blood oxygen levels to determine if patients required immediate, life-saving treatment.

In response, the U.S. Food and Drug Administration (FDA) proposed a new pulse oximeter draft guidance on January 6, which includes new recommendations for manufacturers to improve the accuracy of the devices for people of all skin tones.

The FDA guidance recommends conducting larger clinical studies that include participants with diverse skin tones and encourages researchers to employ both subjective and objective methods for evaluating skin pigmentation. This approach aims to enable manufacturers to label devices that are proven to provide accurate readings across different skin tones.

The updated guidance applies to pulse oximeters intended for medical purposes, primarily used in hospitals or doctor’s offices. A small number of pulse oximeters are approved by the FDA and sold over-the-counter. However, the guidelines do not apply to pulse oximeters that are sold as general wellness products or sporting products.

The agency also proposes creating a public website that lists all FDA-cleared pulse oximeters that can be used across diverse skin colors and have undergone FDA data review.

Comments on the draft guidance should be submitted within 60 days of publication of the guidance. Comments can be submitted to:

Dockets Management Staff (HFA-305), Food and Drug Administration, Docket No. FDA-2023-N-4976, 5630 Fishers Lane, Rm 1061, Rockville, MD 20852.

Problems With Pulse Oximeters

Research dating back to the 1990s has highlighted performance disparities in pulse oximeters for patients of color, but these concerns largely went unaddressed until the COVID-19 pandemic brought them to the forefront.

A study published by researchers from the University of Michigan at the height of the pandemic in 2020 warned that pulse oximeters provided dangerously inaccurate readings for black patients and other people of color. The findings revealed that this led to people of color being less likely to receive life-saving treatment than white patients.

In 2021, the FDA issued a warning to healthcare providers that pulse oximeters may not provide reliable readings for patients with darker skin tones. Then in 2022, a panel of scientific experts recommended the FDA improve the accuracy of pulse oximeters, but did not offer specific recommendations to the agency.

That same summer, another study, published by Johns Hopkins Health System , determined Black, Latino and Asian patients are 30% less likely to receive needed treatment due to inaccurate pulse oximeter readings.

Last year, the FDA called a public advisory committee hearing on pulse oximeters performance problems. The panelists agreed the current rules were too lax for the medical devices and urged the FDA to address the issue.