FDA issues safety notice for pulse oximeter: ‘May be less accurate in people with dark skin pigmentation’

The Food and Drug Administration (FDA) released a notice last week warning that pulse oximeters may be less accurate when used on a patient with a dark skin tone.

“The U.S. Food and Drug Administration is informing patients and health care providers 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,” the FDA said in its notice.

Pulse oximeters have become an essential piece of medical equipment in the coronavirus pandemic since monitoring oxygen levels is crucial when a person has COVID-19.

But a study released in December found that oximeters were more likely to give inaccurate or misleading results when used on Black patients. The device works by shining a red light through a patient’s fingertip, and inaccurate oxygen readings were reported three times more often with Black patients.

The study’s lead author, Michael Sjoding, said that the inaccuracies were not occurring “a lot,” accounting for roughly 12 percent of readings, but that that amount could still be “really impactful.”

The FDA advised patients and caregivers to properly use oximeters by making sure the hand is warm, nail polish is removed, the patient sits still and that they wait a few seconds until the readings stop changing and display on steady number.

The notice also advised against relying solely on oximeters to evaluate oxygen levels. Patients and caregivers should look out for bluish coloring in the face, lips or nails; shortness of breath or difficulty breathing; restlessness or discomfort; chest pain; or a racing pulse rate. It also warned that some patients with low oxygen levels may not display any of these symptoms.