FDA monitoring pulse oximeter accuracy and limitations

Editor's Note

The US Food and Drug Administration (FDA) released a safety communication update on June 21 alerting providers that the agency “continues to evaluate all available information pertaining to factors that may affect pulse oximeter accuracy and performance.”

A May 2022 study published by JAMA Internal Medicine showed that pulse oximeters, which measure blood oxygen saturation levels and are often the first indicator for whether COVID-19 patients exhibiting symptoms need further intervention, are overestimating levels in Asian, Black, and non-Black Hispanic patients.

“Because of ongoing concerns that these products may be less accurate in individuals with darker skin pigmentations, the FDA is planning to convene a public meeting of the Medical Devices Advisory Committee later this year to discuss the available evidence about the accuracy of pulse oximeters, recommendations for patients and healthcare providers, the amount and type of data that should be provided by manufacturers to assess pulse oximeter accuracy, and to guide other regulatory actions as needed,” said the agency in this latest safety communication. These upcoming findings may cause the agency to reassess the content of its pulse oximetry guidance document.

Meanwhile, the FDA continues to urge patients and healthcare providers to be aware of the above limitations and inaccuracy risks. While “pulse oximetry is useful for estimating blood oxygen levels…patients with conditions such as COVID-19…should pay attention to all signs and symptoms of their condition and communicate any concerns to their healthcare provider.”