The pulse oximeter is considered vital in the fight against COVID-19, and it may not work as advertised by people of color.
The U.S. Food and Drug Administration said in a safety notice issued on Friday: “The device may reduce accuracy in people with dark skin pigmentation.”
The FDA’s warning provides a simplified version of a study in recent years or even a few years ago that found racial differences in the performance of pulse oximeters, which can measure oxygen content. Clamp-type devices are attached to people’s fingers and track the amount of oxygen in their blood. Low oxygen levels indicate that COVID-19 patients may get worse.
The FDA cited a recent study in its warning that found that black patients are nearly three times more likely to have dangerously low blood oxygen levels detected by pulse oximeters than white patients.
The U.S. Centers for Disease Control and Prevention also updated its coronavirus clinical guidelines to remind medical professionals of studies that show that skin pigmentation can adversely affect the accuracy of the device.
The move came nearly a month after three U.S. senators called on the agency to review the accuracy of products of different ethnic groups.
“Multiple studies conducted in 2005, 2007, and most recently in 2020 have shown that pulse oximeters provide misleading blood oxygen measurement methods for patients of color,” Massachusetts Democrat Elizabeth Warren, New Jersey Wrote Corey Booker of Oregon and Ron Wyden of Oregon. . They wrote: “Simply put, pulse oximeters seem to provide misleading indicators of blood oxygen levels for colored patients-indicating that patients are healthier than they actually are, and increasing the risk of health problems due to diseases such as COVID-19. The risk of negative impact.”
Researchers speculated in 2007 that most oximeters may be calibrated with light-skinned individuals, but the premise is that skin pigment is not important, and skin color is a factor involved in infrared red light absorption in product readings.
In the new coronavirus pandemic, this issue is even more relevant. More and more people buy pulse oximeters to use at home, and doctors and other health professionals use them at work. In addition, according to CDC data, blacks, Latinos, and Native Americans are more likely to receive hospitalization for COVID-19 than others.
A PhD from the University of Michigan School of Medicine said: “Given the widespread use of pulse oximetry in medical decision-making, these findings have some significant implications, especially during the current coronavirus disease period.” Michael Sjoding, Robert Dickson, Theodore Iwashyna, Steven Gay and Thomas Valley wrote in a letter to the New England Journal of Medicine in December. They wrote: “Our findings indicate that relying on pulse oximetry to shunt patients and adjust supplemental oxygen levels may increase the risk of hypoxemia or hypoxemia in black patients.”
The FDA accused the study of being limited because it relied on “previously collected health record data” in hospital visits, which could not be statistically corrected for other potentially important factors. It said: “However, the FDA agrees with these findings and emphasizes the need for further evaluation and understanding of the link between skin pigmentation and the accuracy of the oximeter.”
The FDA found that in addition to skin color, poor blood circulation, skin thickness, skin temperature, smoking and nail polish, it also affects the accuracy of the product.
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Post time: Feb-25-2021