FDA urged to review accuracy of pulse oximeters for people of color

Three senators are urging the FDA to review the accuracy of pulse oximeters in patients of color after multiple studies have suggested the devices provide misleading measures to patients of color. 

In a letter to acting FDA Commissioner Janet Woodcock, MD, dated Jan. 25, Sens. Elizabeth Warren, D-Mass., Cory Booker, D-N.J., and Ron Wyden, D-Ore., wrote: "With an ongoing pandemic disproportionately affecting communities of color, it can be a matter of life or death that the very device that could help these communities and their healthcare providers detect the need for urgent care is less likely to alert them to risks simply because of the color of their skin." 

A study published Dec. 17 in The New England Journal of Medicine found that pulse oximeters were more often less reliable in Black patients than in white patients. 

The use of pulse oximeters has increased during the COVID-19 pandemic, the senators stated, as the devices are used to determine whether a patient needs supplemental oxygen. If the device indicates patients are healthier than they are, it could increase their risk of negative health effects from diseases like COVID-19, the senators wrote. 

"In order to reduce health disparities and restore trust among communities of color, we must reevaluate the ways in which current practices and clinical tools themselves potentially worsen outcomes for people of color," the senators wrote. 

Because the FDA is in charge of regulating medical devices, the senators urged the agency to review the interaction between skin color and accuracy of pulse oximeter devices. They asked the FDA to answer a list of questions on the matter no later than Feb. 8. 

Read the full letter here.

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