USA – FDA: Oximeters may be inaccurate in Black patients

The US Food and Drug Administration (FDA) has issued a new safety communication about the limitations of using pulse oximeters to assess blood oxygen levels. The communication is based in part on findings that oximeters may yield falsely elevated readings in individuals with dark skin pigmentation, with the potential of masking dangerously low blood oxygen levels.

The agency’s communication comes in the context of the COVID-19 pandemic, which “has caused an increase in the use of pulse oximeters,” both for home use and in healthcare settings. FDA noted that “although pulse oximetry is useful for estimating blood oxygen levels, pulse oximeters have limitations and a risk of inaccuracy under certain circumstances that should be considered.”

At the end of January, Senators Elizabeth Warren, Cory Booker and Ron Wyden wrote to acting FDA commissioner Janet Woodcock, MD, urging the agency « to quickly conduct a review of the accuracy of pulse oximeters…across racially diverse patients and consumers. » …