Statement to FDA on Pulse Oximeter Accuracy and Limitations

Aaron Baugh, MD, presented a prerecorded statement on behalf of CHEST to the Anesthesiology and Respiratory Therapy Devices Panel of the US Food and Drug Administration (FDA) Medical Devices Advisory Committee.

This panel meeting addressed ongoing concerns that pulse oximeters may be less accurate in individuals with darker skin pigmentation, as well as an approach to improve the quality of premarket studies and associated methods used to evaluate the performance of pulse oximeters submitted for premarket review, taking into consideration a patient’s skin pigmentation and patient-reported race and ethnicity.

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