FDA warns pulse oximeters may not work as well on people of color

Posted at 4:05 PM, Feb 23, 2021

WASHINGTON, D.C. – The Food and Drug Administration (FDA) is warning that the pulse oximeters that have become essential tools in the fight against COVID-19 may not work as well on people of color.

A pulse oximeter is a device that is usually clamped onto a fingertip, which uses light beams to estimate the oxygen saturation and the pulse rate of patients.

The spread of the coronavirus, which can cause significant drops in blood oxygen saturation, has spurred a surge in the popularity of over-the-counter versions of these devices.

In a statement released Friday, the FDA said a recent report from The New England Journal of Medicine (NEJM) showed the “devices may be less accurate in people with dark skin pigmentation.”

Officials say that while pulse oximeters are useful for estimating blood oxygen levels, they have limitations and there is a risk of inaccuracy under certain circumstances that should be considered.

“Patients with conditions such as COVID-19 who monitor their condition at home should pay attention to all signs and symptoms of their condition and communicate any concerns to their health care provider,” wrote the FDA in its notice.

The recent NEJM study looked at adult patients who were receiving supplemental oxygen at the University of Michigan Hospital, as well as patients in ICUs at 178 other hospitals. Researchers tested for occult hypoxemia in patients, meaning they checked to see if there was a disconnect between their arterial oxygen saturation and their pulse oximetry.

In the end, researchers say they found the Black patients had nearly three times the frequency of occult hypoxemia that was not detected by pulse oximetry as the white patients.

“Our results suggest that reliance on pulse oximetry to triage patients and adjust supplemental oxygen levels may place Black patients at increased risk for hypoxemia,” wrote NEJM in its report.

Along with the FDA, the Centers for Disease Control and Prevention (CDC) also updated its coronavirus clinical guidance to warns health care providers of the discrepancies related to skin pigmentation.

The notices from the FDA and CDC come after a group of Democratic lawmakers urged the agencies to address concerns about pulse oximeter inaccuracies for people of color.

"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. 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," Sens. Elizabeth Warren, Cory Booker and Ron Wyden wrote in a letter to the FDA commissioner.

The FDA says pulse oximeters cannot be used to diagnose or rule out COVID-19. So, if you think you may have contracted the coronavirus, contact your health care provider or local health department about getting a diagnostic test for COVID-19. If you are concerned about a pulse oximeter reading or if your symptoms are serious or getting worse, the FDA says you should also contact a health care provider.