Testimony Before the FDA’s Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee Regarding Pulse Oximeters
In testimony before the Food and Drug Administration’s (FDA’s) Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee, which was convened to consider factors that impact the accuracy of pulse oximeters — especially skin pigmentation — Public Citizen argued for better device premarket standards to address long-standing concerns that pulse oximeters are too often not sufficiently effective as clinical tools for persons of color because skin pigmentation interferes with blood oxygen saturation readings of these devices.