FDA guidance on pulse oximeters unlikely to end racial bias

A soon-to-be-released Food and Drug Administration guidance to address inaccurate readings of pulse oximeters for people with dark-pigmented skin is unlikely to end racial bias, researchers say. Hospitalized patients often have poor circulation, a common condition for people with cardiovascular disease, and Black people disproportionately have cardiovascular disease. The combination of poor circulation and dark-pigmented skin results in inaccurate readings. Although the FDA has indicated it will recommend manufacturers test new oximeters on more people, including a large percentage with dark-pigmented skin, the FDA is not expected to ask device makers to test oximeters in patients with poor circulation due to industry opposition. As a result, the guidance could result in devices that work in healthy dark-skinned adults only. (KFF article, 8/10/24)