Pulse oximeters have become popular during the COVID-19 pandemic for people to track their oxygen saturation, but they may not always be accurate, the FDA cautioned in new guidance released Friday.
Several factors can affect the accuracy of pulse oximeters, including poor circulation, skin temperature, skin thickness, current tobacco use, use of fingernail polish, and dark skin pigmentation, the FDA said. A recent report in the New England Journal of Medicine shows that Black patients may not receive accurate readings from some oximeters.
"While pulse oximeters may be useful for estimating blood oxygen levels, these devices have limitations that can result in inaccurate readings," William Maisel, MD, director of the FDA's Office of Product Evaluation and Quality, said in a statement.
Maisel encouraged people to pay attention to all of their health symptoms, especially if they experience signs of low oxygen saturation levels, such as shortness of breath or bluish coloring on their face, lips, or nails.
"Patients with conditions such as COVID-19 should not rely solely on pulse oximeter measurements to monitor their health at home as they are not a substitute for a medical diagnosis by a health care provider," he said.
A pulse oximeter, which is typically placed on the fingertip, uses infrared light beams to estimate the amount of oxygen in the blood and the pulse rate.
