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Crackdown on skin-colour bias by fingertip oxygen sensors is coming, hints FDA

Devices can overestimate blood oxygen levels in people with dark skin, affecting medical care.
  1. Max Kozlov
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Evidence is mounting that devices widely used to measure blood oxygen levels can be inaccurate in people of colour1,2,3. As a result, the US Food and Drug Administration (FDA) plans to propose that companies conduct more stringent evaluation of the devices, called pulse oximeters, before applying for agency approval.

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doi: https://doi.org/10.1038/d41586-023-04144-6

Updates & Corrections

  • Update 03 February 2024: This story has been updated with a response from the US Food and Drug Administration.

  • Clarification 05 February 2024: The number of people with “darkly pigmented” skin who, according to US Food and Drug Administration guidelines, must be included in testing of pulse oximeters has been clarified.

References

  1. Sjoding, M. W. et al. N. Engl. J. Med. 383, 2477–2478 (2020).

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  2. Fawzy, A. et al. JAMA Intern. Med. 182, 730–738 (2022).

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  3. Gottlieb, E. R., Ziegler, J., Morley, K., Rush, B. & Celi, L. A. JAMA Intern. Med. 182, 849–858 (2022).

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