Research has shown that devices that measure blood oxygen (oximeters) may be inaccurate in people of color. This problem was confirmed during the COVID pandemic. Knowing the correct blood oxygen level could be the difference between life and death.

NEJM Article

NY Times Article

Senator Warren Letter

NIH – National Library of Medicine

State of California Attorney General Letter

Recent History of the Pigmentation Problem

Oxygen is essential for life because it is required for the process of cellular respiration, which is the process by which cells of the body convert nutrients into energy. Oxygen is carried by the hemoglobin in red blood cells via the circulation to all the living cells of the body. Without sufficient oxygen, the cells are unable to meet their energy needs, which can lead to damage or death of the cells. The brain and heart are particularly vulnerable to low levels of oxygen in the body.

Low blood oxygen (called hypoxemia), can be caused by a variety of conditions that affect the lungs. These include COPD, infections (e.g. COVID or influenza, or RSV), blood clots, fluid in the lungs (e.g heart failure).
A pulse oximeter is a device that measures the oxygen saturation of a patient’s blood. It does this by using a sensor that is placed on a a fingertip or skin. The sensor contains two LED lights, one red and one infrared, that shine through the skin and into the pulsating bloodstream. The amount of light absorbed by the blood is then used to calculate the oxygen saturation, or the percentage of hemoglobin molecules in the blood that are carrying oxygen.

Oximeter accuracy may be affected by the amount of melanin, the pigment that gives color to the skin. Melanin can absorb light, and the more melanin there is in the skin, the less light will reach the blood vessels beneath the skin. This might make it more difficult for the oximeter to accurately measure the oxygen saturation of the blood of some patients. Some studies have found that pulse oximeters may not be as accurate in individuals with darker skin tones, specifically in low oxygen conditions. It’s important to note that it’s still possible for dark skinned individuals to use pulse oximeters, but it’s important to also rely on other clinical signs for a more accurate reading, such as oxygen saturation from blood gas analysis, and physical examination in emergency or critical care settings.

Simply put, pulse oximeters appear likely to provide misleading measures of blood oxygen levels to patients of color- indicating that patients are healthier than they actually are and increasing their risk of negative health impacts from diseases like Covid 19, C O P D, Asthma and Pulmonary Fibrosis.

  • Dec 17, 2020

    Article published in NEJM

    Read Article

  • Dec 22, 2020

    New York Times does an article on Oximeters and Pigment problems

    Read NY Times

  • Jan 07, 2021

    NYC should be commended for being the first city to try to get their hands around pre and post COVID-19. Unfortunately, the attempt needs to be refined
    1. Episodic measurements will not accomplish what they are trying to accomplish They must have continuous blood oxygen
    2. Pigment problems the majority of people who will be receiving oximeters are people of color
  • Jan 25, 2021

    Senators Warren, Booker and Wyden write a letter to the FDA concerning Non  Intended  racial discrimination from pulse oximeters.

    Read Warren

  • Feb 19, 2021

    FDA comes out with notice regarding safety and accuracy of oximeters

    FDA Statement

  • Feb 22, 2021

    CNN reports about the problem with people of Color be misdiagnosed due to improper measurements from Oximeters

  • Feb 23, 2021

    BodiMetrics comes out with Press Release regarding findings of effectiveness of Circul for people of Color

    Press Release

  • Nov 2021

    United Kingdom launches investigations

    BBC

    The Guardian

  • May 31, 2022

    Johns Hopkins release landmark clinical trial The pulmonary world has just been shaken by the biggest earthquake in History

    Read Hopkins

    Important Article

    Washington Post

  • Aug 12, 2022

    Senators Warren, Booker, Markey, Wyden, and Duckworth Renew Request for FDA to Address Concerns about Dangerous Pulse Oximeter Inaccuracies | U.S. Senator Elizabeth Warren of Massachusetts

    Warren, Senate

  • Nov 11, 2022

    FDA panel examines evidence that pulse oximeters may not work as well on dark skin
    CNN Article

  • Dec 29, 2022

    Apple Sued For Pigmentation Problem

    Forbes Article

    USA Today

  • Jan 29, 2023

    Article in JAMA that lays out 40 years knowledge of the problem and is a road map for class actions

    Read Article

  • Nov 1, 2023

    State of California Attorney General letter regarding concerns related to pulse oximeters’ race and color bias.  Read Letter

  • March 11, 2024

    New action to tackle ethnic and other biases in medical devices Gov.uk
  • March 20, 2024

    People with darker skin are 32% more likely to have pulse oximeter readings overestimate oxygen levels, report says CNN.com
  • March 20, 2024

    Black Patients 32% More Likely Than White Patients to Experience Occult Hypoxemia, Which May Result in Delayed Care

    Epic Research