The doctors and nurses didn\u2019t believe Tomisa Starr was having trouble breathing.<\/p>\n
Two years ago, Starr, 61, of Sacramento, California, was in the hospital for a spike in her blood pressure. She has multiple chronic health problems, including heart failure, and uses an oxygen tank at home.<\/p>\n
But her request for supplemental oxygen while hospitalized was denied, Starr said, because readings from a pulse oximeter on her finger falsely indicated that she was getting plenty of air on her own.<\/p>\n
Starr, who is Black, said she told the care team about research showing that the devices, which measure oxygen levels in the blood, may not work as well on people with darker skin and potentially make those patients seem healthier than they really are.<\/p>\n
Their response, Starr said, was shocking.<\/p>\n
\u201cThe provider demanded to know, \u2018Who told you that?\u2019\u201d she said. \u201cHere I am in the hospital, and I have to defend myself, like I\u2019m in court.\u201d<\/p>\n The skepticism Starr said she faced from doctors about potentially false pulse oximeter readings in Black Americans is not unique.\u00a0<\/p>\n \u201cI give talks on this all the time to physicians who should know the research, and they\u2019re always blown away,\u201d said Dr. Hugh Cassiere, a critical care physician at South Shore University Hospital in New York. \u201cThis device has built-in racial disparities that have been ignored for years.\u201d Cassiere also heads a committee of independent experts assembled by the FDA to look into the pulse oximetry issue.<\/p>\n Potential problems with the measurement devices have been known for decades. The FDA began to develop guidance for manufacturers to address the issues in 2013, but little has been done since. <\/p>\n It wasn\u2019t until the pandemic that the real dangers to Black patients became clear. In 2021, the Food and Drug Administration warned <\/a>about flawed pulse oximeter readings on darker skin.<\/p>\n Last week, the FDA issued draft guidance<\/a> for manufacturers to drastically expand the skin tone varieties when testing their devices and show they work equally for all skin pigments.<\/p>\n Historically, companies haven\u2019t been required to include a significant number of dark-skinned people in studies of pulse oximeters.<\/p>\n \u201cQuite frankly, how we\u2019ve measured it hasn\u2019t been consistent or done in a very valid or systematic way,\u201d the head of the FDA\u2019s Center for Devices and Radiological Health, Dr. Michelle Tarver, told NBC News in an interview before the draft guidance was issued. <\/p>\n Cassiere expressed support for the new recommendations. \u201cThis is light years ahead of the 2013 guidance,\u201d he said. <\/p>\n The Food and Drug Administration doesn\u2019t\u00a0approve or authorize all pulse oximeters on the market. Devices marketed for \u201cgeneral wellness\u201d among hikers, cyclists or other athletes who might want to estimate their blood oxygenation, for example, aren\u2019t regulated and should never be used to diagnose or monitor health problems, the FDA said.<\/p>\n Pulse oximeters specifically intended for medical use do fall under FDA purview. It\u2019s these device manufacturers that the agency is targeting with its draft guidance. <\/p>\n The gold standard and most accurate way of testing whether a person has normal oxygen levels is to stick a needle into a person\u2019s wrist and draw blood.<\/p>\n An arterial blood draw, as it\u2019s called, is invasive and painful. But it also gives doctors an essential clue as to how well a patient\u2019s lungs are functioning, providing insight into which patients should be hospitalized and receive supplemental oxygen or other treatment.<\/p>\n Pulse oximeters came along in the 1980s as an easy and painless alternative. The device shines a light through the fingertip, seeking out oxygen-rich blood. The more light that\u2019s absorbed, the better, in theory.<\/p>\n But that light is also absorbed by melanin, or pigment, in the skin. As a result, Black and brown people are more likely to get pulse oximeter readings that show their blood oxygen saturation is higher than it really is. That is, they could be struggling for air despite normal pulse oximeter results.<\/p>\n The potential for racial disparities in pulse oximetry was first revealed in a study published 34 years ago<\/a>. “That should have gotten the FDA’s attention,” Cassiere said.<\/p>\n It was largely disregarded.<\/p>\n \u201cI went to medical school at Howard University, which is a historically Black college, and this never, ever came up \u2014 never in training, never in practice,\u201d said Dr. Noha Aboelata, founder and chief operating officer of Roots Community Health in Oakland, California. \u201cI never knew anything about it until the first year of the pandemic.\u201d<\/p>\n It was Dr. Thomas Valley and his colleagues at the University of Michigan who reignited rumblings about the discrepancy in 2020 as they were inundated with Covid patients. The vast majority of the sickest patients were Black.<\/p>\n \u201cWe started to notice that the numbers on the screen for pulse oximeters weren\u2019t matching what we were seeing in arterial blood,\u201d Valley said. \u201cWe would go from room to room to room and see that these numbers didn\u2019t look quite right.\u201d<\/p>\n The team figured it was an anomaly caused by Covid \u2014 a brand-new virus the world hadn\u2019t seen before.<\/p>\n \u201cIt wasn\u2019t until several months later that a light bulb went off,\u201d Valley said. \u201cThis isn\u2019t a Covid problem. This is a \u2018color of one\u2019s skin\u2019 problem.\u201d<\/p>\n His team published its findings about racial biases in pulse oximeter readings in December 2020<\/a>. It was this study, published in the prestigious New England Journal of Medicine, that Starr used to alert her doctors.<\/p>\n While there\u2019s no direct link between faulty pulse oximeter readings and Covid deaths, additional research <\/a>has found that people of color were more likely to die of Covid than white people.<\/p>\n The apparent disparities go beyond treatment for Covid.<\/p>\n The faulty pulse oximeter readings for patients of color \u201ccould preclude Black patients from being candidates for advanced therapy\u201d such as heart pumps or heart transplants, said Sarah Adie, associate director of innovation at the University of Michigan Health Frankel Cardiovascular Center. She is a co-author of a study published in 2024<\/a> that found unreliable pulse oximeter readings might limit the way Black patients with heart failure qualify for those potentially lifesaving procedures.<\/p>\n![\"Tomisa.\"](\"https:\/\/media-cldnry.s-nbcnews.com\/image\/upload\/t_fit-760w,f_auto,q_auto:best\/rockcms\/2024-12\/241206-tomisa-ch-1632-7e2e1e.jpg\")
<\/picture>How pulse oximeters work<\/h2>\n
![\"Oximeters.\"](\"https:\/\/media-cldnry.s-nbcnews.com\/image\/upload\/t_fit-760w,f_auto,q_auto:best\/rockcms\/2024-12\/241206-cupulseoxhand-ch-1634-382224.jpg\")
<\/picture>The light bulb moment<\/h2>\n
![\"People](\"https:\/\/media-cldnry.s-nbcnews.com\/image\/upload\/t_fit-760w,f_auto,q_auto:best\/rockcms\/2024-12\/241206-lipnickarterialblood-ch-1632-b40544.jpg\")
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