FDA acknowledges skin pigmentation may affect pulse oximeter accuracy

The FDA issued an alert Feb. 19 saying that pulse oximeters have limitations and that certain factors, including skin pigmentation, may affect the device's accuracy. 

The FDA pointed to a study published in The New England Journal of Medicine in December that suggested pulse oximeters were more often less reliable in Black patients than white patients. In January, three senators wrote a letter to the FDA urging the agency to review the accuracy of pulse oximeters in people of color. 

Pulse oximeters are used to determine a patient's blood oxygen level, and use of the devices has spiked during the COVID-19 pandemic, according to the FDA. 

In the alert, the FDA said that pulse oximeter readings can be affected by multiple factors, including skin pigmentation, skin thickness, poor circulation, skin temperature, tobacco use and fingernail polish. 

"The most current scientific evidence shows that there are some accuracy differences in pulse oximeters between dark and light skin pigmentation; this difference is typically small at saturations above 80 percent and greater when saturations are less than 80 percent," the FDA wrote.  

The FDA said it believes the study's findings highlight the need to further evaluate and understand the association between skin pigmentation and oximeter accuracy, and that it will review more studies on pulse oximeter accuracy. 

"The FDA has been working on additional analysis of premarket data, as well as working with outside stakeholders, including manufacturers and testing laboratories, to analyze additional postmarket data to better understand how different factors, including skin pigmentation, may affect pulse oximeter accuracy," the agency wrote. 

Read the full alert here


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