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FDA Panel Reviews Pulse Oximeter Accuracy for Darker Skin Tones

An FDA advisory panel convened to address the inaccuracies of pulse oximeters on darker skin, aiming to improve health equity and patient care.

A closeup shot of a pulse oximeter on a black woman's finger to measure pulse rate and oxygen levels
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Overview

  • The FDA advisory panel met to discuss making pulse oximeters more accurate for people with darker skin, following research indicating significant inaccuracies.
  • Research has shown that pulse oximeters often provide incorrect readings for darker skin tones, leading to treatment delays and worse health outcomes for minorities.
  • Over 20 state attorneys general have urged the FDA to update guidelines to include warnings about pulse oximetry’s inaccuracy on darker skin.
  • The FDA issued a warning in 2021 about the limitations of pulse oximeters, highlighting their risk of inaccuracy under certain conditions.
  • Experts emphasize the need for devices that do not discriminate based on skin color, advocating for health equity and the development of more inclusive medical devices.