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FDA Wants To Change The Way Pulse Oximeters Are Misreading Oxygen Levels In People Of Color 


The FDA has proposed new guidelines requiring medical device makers to gather additional data ensuring pulse oximeters work effectively for patients of color. These clip-on devices, widely used in hospitals to measure blood oxygen levels, have faced scrutiny for producing inaccurate readings in individuals with darker skin tones.


“Oximeters were a critical part of emergency care for patients with COVID-19,” the FDA noted, but studies revealed they often overestimated Black patients’ oxygen levels. This inaccuracy could delay treatment and heighten health risks. The proposal comes after the FDA issued warnings in 2021 and held multiple meetings since 2022 to address racial biases in medical technology.


Key changes in the recommendations include requiring clinical trials to enroll at least 150 patients with varied skin tones, ensuring 25% have darker complexions—an increase from the previous 15%. Manufacturers must also assess skin pigmentation using two methods: visual evaluation and a scientific measurement of melanin levels.


The FDA emphasized that the draft guidelines focus solely on professional-grade oximeters used in clinical settings and do not apply to over-the-counter devices marketed for general wellness. While older devices won’t be removed, manufacturers will need to provide updated diversity data if seeking modifications to existing products.


“This issue highlights the potential racial biases in medical technology,” the agency stated, stressing the need for inclusivity in research.


The guidelines remain in draft form, and the FDA is accepting public comments for 60 days before finalizing the rules.



Link: AP News

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