FDA warns of “limitations” of pulse oximeter

Democratic lawmakers expressed concern about possible racial differences in pulse oximeter readings (calling this a “life and death” issue) two months after the U.S. Food and Drug Administration (FDA) issued a public warning on these devices on Friday. Acknowledge their “limitations”.
For the first time in decades, researchers have discovered possible inaccuracies when using the device by people of color, and a series of new studies have produced new data highlighting the problem and issued a warning several months later. Recently, researchers from the University of Michigan published a letter in the December 2020 issue of the New England Journal of Medicine, and found that the probability of missing hypoxemia with an oximeter was three times that of black patients.
“Please note that many factors can affect the accuracy of pulse oximeter readings, such as poor circulation, skin pigmentation, skin thickness, skin temperature, current tobacco use, and nail polish use,” the FDA warning read.
It does not explicitly mention ethnic differences in equipment accuracy, which may disappoint clinicians and patients who try to draw attention to the problem.
“It is worth noting that the term’race’ or’race’ is not mentioned in the FDA communications,” said Thomas Valley, a pulmonary intensive care physician and author of the NEJM letter. “At the same time, we found that there is a difference between black and white patients. We don’t know why there is such a difference, we think it is skin color.”
During the Covid-19 pandemic, pulse oximeters used to measure oxygen levels have become a particularly useful clinical tool because the virus interferes with the body’s natural ability to process oxygen. In hospitals, equipment plays a vital role in making decisions about patient care. At the end of last spring, after several practitioners suggested that it might be useful to keep the device at home (for example, similar to the way people might want to keep a thermometer in a medicine cabinet), the home version of the device started flying off the shelves in pharmacies and Amazon and other online sites quickly sold out.
However, last December’s paper (and its references to a series of earlier studies documenting the same problem, including papers published in 2005) shocked researchers and clinicians, who said that they did not get the substance in order to learn about the problem. Frustrated by sexual resolution. 15 years.
Utibe Essien, an assistant professor of medicine at the University of Pittsburgh School of Medicine, said: “I can’t believe the accuracy of this number, and relying on devices that may bias certain groups of people is really disturbing.”, Tell STAT earlier this month.
In response to these concerns, William Maisel, director of the Office of Product Evaluation and Quality of the FDA’s Center for Equipment and Radiological Health, told STAT that the agency is reviewing available data and considering further research if necessary. He said that the FDA is confident that hospital-based oximeters have a high degree of accuracy, but added that for devices sold online and in pharmacies, this may not be correct, and the agency has not reviewed or approved this.
Michael Schuddin, a pulmonologist at Michigan State University and author of the NEJM letter, said he is pleased that the FDA has emphasized in its statement the importance of not relying too much on pulse oximeters to make medical decisions. However, he added that he believes that not explicitly mentioning race is a “missed opportunity.”
He said: “Given the limitations of this article, I suspect that the FDA wants to be vigilant in their information about racial differences in pulse oximeter accuracy, and focus more on the issue of pulse oximeter accuracy.”
Erin is a health technology reporter in California and a co-author of the STAT Health Tech newsletter.
Statnews, are we doing child labor now? Biology and physics are taught in classes above elementary school, but the author of this article does not seem to know biology and physics.
As one commenter suggested, it is a good thing for the author to edit the article from “oxygen-producing body” to “oxygen-producing body”.
The light is blocked/absorbed by the pigment. The color you see in the paint is the color reflected by the paint. Therefore, what you see is black, which means that the primary colors in the reflection spectrum are not primary colors. White, all colors are reflected. The oximeter works under light, so it is greatly affected by blocked light/absorbed light.
It seems that the authors of this article have not yet received biology and physics, so they must only have basic education. Since junior high school and high school are compulsory courses, teaching biology and physics, it can help us think about whether to engage in child labor here, so that elementary school children can write this article. Have we got the consent of our parents?
Finger oxygen measurement uses infrared light to detect oxygen saturation, because oxidized hemoglobin absorbs more infrared light. SO: Based on light detection, this device is less effective for people with darker skin. This has been known for more than 20 years, but no measures have been taken to adapt. The FDA should clearly state this, which may stimulate the development of (finger) oxygen meters, because DOES works better for dark-skinned people. The “racial prejudice” in the title of this article is a color expression of a very transparent defect (pun intended).
Author, I am ashamed of your increased racial division. Your article reduces the quality of statnews. However, at that time you were not alone in doing this in statnews. Maybe the quality of statnews is declining.
When did the Liberal Party’s racial stuff stop when it went crazy? Race oximeter? It’s like racist covid-19. Liberalism is a dangerous mental illness. No, liberals are certainly not racists. They treat everyone equally. They hate everyone legally in the United States.
The oximeter uses a light beam to measure oxygen. If you have any objects that block the light (such as paint, nail polish, etc.), the light beam will be affected. A little common sense rather than racial prejudice.
Ignorant doctors who comment on racial prejudice are stupid. The laws of physics are blind to race and are governed by the laws of physics. When the professor/teacher teaches the basic knowledge of light propagation, diffraction, and absorption, he seems to be sleeping in class. I don’t want a stupid doctor like him to treat me.
The author should do a lot of research on how the oximeter works, not a racial bait conspiracy.
Does the degree of melanization of a person’s skin and nail bed play a physiological role in light absorption and transmission? I remember a recent article published in NEJM (New England Journal of Medicine) raised this question. As a science-oriented individual and a practicing physician, I welcome consideration of any views and insights that may help me evaluate patients. My first consideration is that the possibility of pulse oximeter readings will be affected by the level or intensity of melanin in the skin and nails. That is biology and physics! The absorption of ultraviolet light through the skin and how it affects the production and metabolism of vitamin D in the skin further illustrates this point. Melanin can actually reduce the absorption of UVB light into the skin! It is important to understand and understand this.
Not all science is “racist”! Unless and until we have read, studied and studied “Science”, we should be very careful not to draw wrong conclusions!


Post time: Mar-03-2021