Pulse oximeters are small devices, usually placed on a finger, that estimate the level of oxygen in the blood. Evidence shows they may be less accurate in people with darker skin. This problem gained wider attention during the COVID-19 pandemic, when inaccurate readings led to delayed treatment for some patients with darker skin.
In January 2025, the US Food and Drug Administration (FDA) proposed draft guidance with updated recommendations for pulse oximeters used for medical purposes, mainly in hospitals and doctors’ offices. Manufacturers should collect clinical data to assess how accurate their devices are across different skin tones. They should also include more study participants, so that studies better reflect the patients who will use the device, and use standardised methods to classify participants’ skin tone, such as the Monk Skin Tone scale.
The FDA also recommends that labels clearly state any limitations of the device for different skin tones, and it plans a public website listing cleared pulse oximeters. The guidance does not cover devices sold for general wellness or sports. Together, these measures aim to help patients and health professionals identify devices that work reliably for everyone.
Learn more here: https://www.fda.gov/news-events/press-announcements/fda-proposes-updated-recommendations-help-improve-performance-pulse-oximeters-across-skin-tones
Reference:
U.S. Food and Drug Administration. (2025, January 6). FDA proposes updated recommendations to help improve performance of pulse oximeters across skin tones [Press announcement].