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Two months after Democratic lawmakers expressed concern about potential racial disparities in pulse oximeter readings — calling the issue a matter of “life or death” — the Food and Drug Administration on Friday issued a public warning about the devices, acknowledging they had “limitations.”

The alert comes decades after researchers first identified potential inaccuracies with the devices when used on people of color and months after a series of new studies produced fresh data underlining the problem. Most recently, researchers at the University of Michigan published a December 2020 letter in the New England Journal of Medicine that found oximeters were nearly three times as likely to miss hypoxemia in Black patients compared with white patients.

“Be aware that multiple factors can affect the accuracy of a pulse oximeter reading, such as poor circulation, skin pigmentation, skin thickness, skin temperature, current tobacco use, and use of fingernail polish,” the FDA’s alert reads.

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It does not explicitly mention racial disparities in the accuracy of the devices, likely disappointing clinicians and patients who have sought to draw attention to the issue.

“It’s noticeable that the word ‘race’ or ‘racial’ is not mentioned in the FDA communication,” said Thomas Valley, a pulmonary critical care physician and an author of the NEJM letter. “At the same time, what we found was a difference between Black and white patients. We don’t know exactly why that difference existed, we presume it to be skin tone.”

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Pulse oximeters, which measure oxygen levels, have emerged as a particularly useful clinical tool amid the Covid-19 pandemic because of the way the virus interferes with the body’s natural ability to process oxygen. In hospitals, the devices play a critical role in making decisions about patient care. And late last spring, after several practitioners suggested the devices could be helpful to have on hand at home (similar to the way one might want to keep a thermometer in the drug cabinet, for example), at-home versions of the devices began flying off drugstore shelves and rapidly selling out on Amazon and other online sites.

But the December paper — and its reference to a series of earlier studies documenting the same problem, including one published in 2005 — raised alarms among researchers and clinicians, who said they were frustrated to learn the issue had not been addressed in a substantive way after 15 years.

“To not be confident in the accuracy of that number, and to depend on a device that may have bias toward a certain population is really troubling,” Utibe Essien, a physician and an assistant professor of medicine at the University of Pittsburgh School of Medicine, told STAT earlier this month.

In response to these concerns, William Maisel, director of the Office of Product Evaluation and Quality at the FDA’s Center for Devices and Radiological Health, told STAT the agency was reviewing the available data and would consider further studies if necessary. He said the FDA is broadly confident that hospital-based oximeters are highly accurate, but added the same might not be true for devices sold online and in drugstores, which the agency doesn’t review or approve.

Michael Sjoding, a pulmonary physician at Michigan Medicine and an author on the NEJM letter, said he was happy the FDA stressed the importance of not over-relying on pulse oximeters to make medical decisions in its statement. He added, though, that he thought the absence of an explicit mention of race was a “missed opportunity.” 

“Given the limitations of our paper … I suspect the FDA wants to be fairly guarded in their messaging about racial disparities in pulse oximeter accuracy and focus more on the problem of pulse oximeter inaccuracy more generally,” he said.

  • “the virus interferes with the body’s natural production of oxygen.”

    The human body doesn’t produce oxygen. Please proof read this trash before posting it or run it by someone who knows at least basic biology.

    • Yes, I am surprised that statnews is supposed to be geared toward medical news but I observed that the authors in statnews seems to have very little knowledge of even biology 101, or even botany 101.

      Sometimes the article are more of trying to incite intrigues like the comments of racial bias in this article.

      For the author, living organisms uses the oxygen and produces Carbon dioxide as by product. Oxygen enters the lungs, distributed thru the blood streams to different cells in the body.

  • Actually the color of skin has nothing to do with race. Some Asian people who are born white but because they are expose to the sun since young, they end up having brown skin. If you look at the Chinese in the US, they have brown skin, but if you look at China or Taiwan, they have light skin if they are not expose to sun for long period of time when they are young.

    So lets us not put race in everything, racial bias is becoming so overuse it is losing its true meaning and importance.

  • The full text of the 2/19/21 Safety Communication is available here: https://www.fda.gov/medical-devices/safety-communications/pulse-oximeter-accuracy-and-limitations-fda-safety-communication

    It does specifically reference the disparity in the performance of pulse oximeters between black and white patients: “Many patient factors may also affect the accuracy of the measurement. The most current scientific evidence shows that there are some accuracy differences in pulse oximeters between dark and light skin pigmentation; this difference is typically small at saturations above 80% and greater when saturations are less than 80%. In the recently published correspondence by Sjoding, et. al., the authors reported that Black patients had nearly three times the frequency of occult hypoxemia (low oxygen levels in the blood) as detected by blood gas measurements but not detected by pulse oximetry, when compared to White patients.” It also makes clear that “FDA agrees that these findings highlight a need to further evaluate and understand the association between skin pigmentation and oximeter accuracy.”

    The announcement also references a guidance where FDA “recommends that every clinical study have participants with a range of skin pigmentations, including at least 2 darkly pigmented participants or 15% of the participant pool, whichever is larger. Although these clinical studies are not statistically powered to detect differences in accuracy between demographic groups, the FDA has continued to review the effects of skin pigmentation on the accuracy of these devices, including data from controlled laboratory studies and data from real world settings.”

    I don’t mean to say that this issue is unimportant, because it’s clearly not. Nor am I assuming that anything was intentionally excluded from this article in a highly respected publication. But reading the full announcement, race does seem to be explicitly addressed, and it also seems like a priority for the agency going forward in its regulation of pulse oximeters. (Note: I am not affiliated with FDA in any way.)

    What am I missing? How should FDA be better amplifying this issue?

  • I am an African American who was issued a pulse oxygenator by the VA during my COVID-19 infection. I was required to send Oxegen, Resperation levels to my COVID-19 monitor for 14 days after symptoms had subsided. The Pulse Oximeter sent to me was under the name (NONIN).

    • That is one of brand with FDA approved oximeters. Not sure if the model you have is FDA approved. It was out of stock then and very expensive. You are fortunate to have one.

    • I absolutely agree. This systemic racism by pulse oximeters has to stop immediately. Remember: BLACK OXIMETERS MATTER!!

    • P.S. please forgive the delay in replying but I actually have a life that doesn’t revolve around debating total strangers to impress other total strangers. I thought your original posts were pretty much on the mark though.

    • @Well, with people using “racist” on every little things that is not even racist, one can easily assume a satire as a stupid comment. For example this author, it was pure science but decided to bring race into it.

      BTW, my original comment is directed toward Zina.

  • In what direction are oximeters inaccurate do they tend to give overly high or lower readings? And is the inaccuracy the same for elderly as it is for racial differences

  • You people seriously gotta get your head checked.
    Get medical care and I hope you get to see the reality of your absurdity, regarding your article about oximeters are 3 times more likely to have a inaccurate reading on color of race.

  • If it is such an outrage to not mention racial differences in oximeter accuracy, why is it not also an outrage to not mention being OLD is even more of a problem for accuracy? The elderly with attendant poor circulation, cold thin hands, etc. often cannot have any kind of accurate reading from a home oximeter. A blood gas test is most accurate.

  • I am a 71 years young Asian woman who has concerns about the oximeter as I was urged to purchase one to use at home, by my doctor, and it has not given me a correct reading, not even once. Could it possibly be related to the issues you have described? I am asking because you only address that there may be a difference between white and black persons and no mention of any other skin color. What are your thoughts regarding my dilemma?

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