FDA urged to move faster to fix pulse oximeters for darker-skinned patients
The Food and Drug Administration should move more quickly to ensure pulse oximeters work well in all patients, advocates testified during a public meeting.
The Food and Drug Administration should move more quickly to ensure pulse oximeters — the ubiquitous devices used to measure blood oxygen — work well in all patients, should better inform clinicians about the devices’ shortcomings in patients with darker skin, and should recall versions that are particularly problematic, patients, researchers, and consumer advocates testified during a public meeting on Friday.
The testimony occurred during an advisory panel meeting, held virtually to consider how to improve the safety of pulse oximeters, It comes more than three years after a study published at the height of the Covid-19 pandemic found that the devices didn’t detect low oxygen levels in some patients with darker skin, and after other studies showed the devices were tied to no or delayed treatment for Black patients with severe Covid.
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