FDA warns that pulse oximeter readings are inaccurate for people with darker skin

Since the beginning of the pandemic, sales of pulse oximeters have been on the rise because low blood oxygen levels are one of the main symptoms of COVID-19. However, for people with darker skin, non-invasive tools seem less accurate.
The U.S. Food and Drug Administration issued a warning last week about how a person’s skin color affects its accuracy. According to the warning, various factors such as skin pigmentation, poor blood circulation, skin thickness, skin temperature, tobacco use and nail polish can affect the accuracy of pulse oximeter readings.
The FDA also pointed out that pulse oximeter readings should only be used as an estimate of blood oxygen saturation. Diagnosis and treatment decisions should be based on the trend of pulse oximeter readings over time, rather than absolute thresholds.
The updated guidelines are based on a study titled “Racial Bias in Pulse Oximetry” published in the New England Journal of Medicine.
The study involved adult inpatients receiving supplemental oxygen therapy at the University of Michigan Hospital (from January 2020 to July 2020) and patients receiving intensive care units in 178 hospitals (2014 to 2015).
The research team wanted to test whether the pulse oximeter readings deviated from the numbers provided by the arterial blood gas test. Interestingly, in patients with darker skin, the misdiagnosis rate of non-invasive devices reached 11.7%, while that of patients with fairer skin was only 3.6%.
At the same time, Dr. William Maisel, director of the Center for Equipment and Radiological Health of the Office of Product Evaluation and Quality of the FDA, said: Although pulse oximeters may help estimate blood oxygen levels, the limitations of these devices may cause inaccurate readings.
According to CNN, the Centers for Disease Control and Prevention (CDC) has also updated its guidelines on the use of pulse oximeters. Data provided by the Centers for Disease Control and Prevention (CDC) also showed that Native Americans, Latinos and black Americans are more likely to be hospitalized due to complications caused by the novel coronavirus (2019-nCoV).
On January 6, 2021, in the Covid-19 Intensive Care Unit of Martin Luther King Community Hospital in Los Angeles, a nurse wearing personal protective equipment (PPE) and including a personal air purifying respirator shuts down the road The door of the ward. Photo: AFP/Patrick T. Fallon