January 28, 2021

Senators Warren, Booker and Wyden Urge FDA to Address Concerns about Dangerous Pulse Oximeter Inaccuracies for Patients of Color

Recurring studies have found that these devices - which measure blood oxygen levels and can help identify COVID-19 risks - are less accurate in Black patients because of racial bias in their calibration process; "Racial disparities in health care stem from a wide variety of factors, and it is particularly disturbing that racism may be embedded in key clinical tools"

Text of Letter (PDF)

Washington, DC - United States Senator Elizabeth Warren (D-Mass.), a member of the Senate Committee on Health, Education, Labor, and Pensions (HELP), and Senators Cory Booker (D-N.J.) and Ron Wyden (D-Ore.) sent a letter to Janet Woodcock, Acting Commissioner of Food and Drugs at the U.S. Food and Drug Administration (FDA), urging the FDA to quickly conduct a review of the accuracy of pulse oximeters -- devices used to monitor blood oxygen levels -- across racially diverse patients and consumers. Multiple studies done in 2005, 2007, and most recently, in 2020, suggest that pulse oximeters provide misleading measures of blood oxygen levels to patients of color.

"The FDA is tasked with regulating medical devices in the U.S., including pulse oximeters. We therefore ask the FDA to conduct a review of the interaction between a patient's skin color and the accuracy of pulse oximetry measurements," the senators wrote

Sales of pulse oximeters began increasing this year, with many retail pharmacies selling out amid reports that the devices "give you valuable information about your health during a bout of COVID-19." Despite the widespread purchases of pulse oximeters and the advice by some in the medical field that they be used with suspected cases of COVID-19 infection, the medical community has long acknowledged that there may be inaccuracies in pulse oximetry measurement devices related to racial bias in the way they are calibrated.

One 2005 study noted that "(m)ost pulse oximeters have probably been calibrated using light-skinned individuals, with the assumption that skin pigment does not matter." However, skin pigment does appear to matter to pulse oximeter measurements, as demonstrated by the 2005 study, as well as a 2007 study, and a recent 2020 study, which found that low levels of oxygen in the blood of Black patients was nearly three times as likely to be undetected than it was in white patients. 

"Simply put, pulse oximeters appear likely to provide misleading measures of blood oxygen level to patients of color-indicating that patients are healthier than they actually are and increasing their risk of negative health impacts from diseases like COVID-19," wrote the senators

"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 continued. "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 health care providers detect the need for urgent care is less likely to alert them to risks simply because of the color of their skin. Racial disparities in health care stem from a wide variety of factors, and it is particularly disturbing that racism may be embedded in key clinical tools."

The senators have requested a response to their letter no later than February 8, 2021.

Last year, Senators Warren, Booker, and Wyden and Congresswoman Barbara Lee (D-Calif.), sent a letter to the Agency for Healthcare Research and Quality (AHRQ) requesting a review of the use of race-based clinical algorithms in standard medical practices. AHRQ responded that they are conducting a review.

Since the beginning of the pandemic, Senator Warren has been working to ensure racial equity in the federal response to COVID-19.

  • Recently in January 2021, Senator Warren sent a 15-page memo to the then-incoming Biden-Harris administration identifying the need to address the pandemic's disproportionate impact on vulnerable populations, especially communities of color and individuals living and working in nursing homes, assisted living facilities, prisons, behavioral health facilities, and other congregate settings.
  • In September 2020, Senator Warren and Representatives Ayanna Pressley (D-Mass.) and Lee introduced a bicameral bill to confront the public health impacts of structural racism
  • In April 2020, Senator Warren led her colleagues in introducing bicameral legislation to require the federal government to collect and report coronavirus demographic data, including race and ethnicity.