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HEALTH NOTES: FDA Warns of Potential Inaccurate Readings of Pulse Oximeters, Citing Report on Race

March 02, 2021

Last month, the U.S. Food and Drug Administration (FDA) issued an alert concerning the use of pulse oximeters to measure blood oxygen levels, warning that the devices “have limitations and a risk of inaccuracy under certain circumstances that should be considered.”

The alert references a December study published in The New England Journal of Medicine finding that pulse oximeters failed to detect below-normal levels of oxygen for Black patients at rates three times higher than for white patients. The FDA recommends that people do not rely only on pulse oximeters when assessing their health, including the decreased oxygen levels seen in people with COVID-19.

“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,” the alert said. “Be aware that multiple factors can affect the accuracy of a pulse oximeter reading, such as poor circulation, skin pigmentation, skin thickness, skin temperature, current tobacco use, and use of fingernail polish.”

The authors of the NEJM report, from the University of Michigan Medical School, called for the need to “correct racial bias in pulse oximetry and other forms of medical technology.”

Women’s Health Research at Yale Director Carolyn M. Mazure, Ph.D., agreed that researchers and medical providers must better understand how differences between and among people of different racial groups and genders affect all aspects of health and health care.

“This study underscores how little we still know about large segments of human biology and behavior and how best to measure and treat many diseases and conditions,” Mazure said. “We must not assume that what works for one group of people works for everyone.”

Submitted by Rick Harrison on March 02, 2021