Food and Drug Administration (FDA) 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 Coronavirus Disease 2019 (COVID-19) pandemic has caused an increase in the use of pulse oximeters, and a recent report ( Sjoding et al.) suggests that the devices may be less accurate in people with dark skin pigmentation. The FDA will share with the public any additional updates to the information and recommendations below. The FDA is reviewing the committee’s recommendations and will consider additional actions as needed.
On November 1, 2022, the FDA convened a virtual public meeting of the CDRH Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee to share information and perspectives from interested parties about ongoing concerns that pulse oximeters may be less accurate in individuals with darker skin pigmentations.
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