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Statement to FDA on Pulse Oximeter Accuracy and Limitations
Aaron Baugh, MD, presented a prerecorded statement on behalf of ÀÖ²¥´«Ã½ to the Anesthesiology and Respiratory Therapy Devices Panel of the US Food and Drug Administration (FDA) Medical Devices Advisory Committee.
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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