FDA Advisory Panel Agrees Pulse Oximeter Skin Pigment Discrepancies Pose Clinical Threat
The FDA’s Anesthesiology and Respiratory Therapy Devices advisory panel met to discuss racial and skin-pigmentation bias in pulse oximeter devices as well as recommendations for the agency.
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US regulators plan to hold a public meeting later this year to address concerns the devices are less accurate for people with darker skin tones.
The US agency’s safety alert says the devices, which measure blood oxygen levels, may be less accurate in patients with darker skin tones.