Outside advisers to the Food and Drug Administration on Tuesday found “a clear signal” that pulse oximeters are less accurate for people with darker skin after scrutinizing evidence during a daylong meeting.
Why it matters: The expert panel’s consensus that inaccuracies pose a distinct clinical risk for dark-skinned patients sets the stage for the FDA to further scrutinize manufacturing standards for the devices, which measure oxygen levels in the blood.
Driving the news: Wednesday’s meeting followed years of longstanding concerns that were brought to the fore during the COVID-19 pandemic, when oximeters were widely used at home and in clinical settings.
Yes, but: The panel split over recommendations for how to limit these inaccuracies in the future.
What they’re saying: “There needs to be transparency around it. How much inaccuracy is permissible? I’m not sure that there’s a right answer,” said panel chair Steven Nathan, the medical director of Inova’s Advanced Lung Disease and Lung Transplant Program.
Courtesy: (Axios)
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