Wisconsin AG signs-on to letter pushing for pulse oximeter warning



(The Center Square) – Add Wisconsin to the list of states wanting a warning on pulse oximeters for people with darker skin.

Attorney General Josh Kaul signed-on to a letter to the FDA, asking for a warning about the limits of pulse oximeters.

“We are urging the FDA to take additional steps to prevent inequities in health care resulting from the use of pulse oximeters,” Kaul said in a statement.

“Pulse oximeters are routinely used to determine blood oxygen levels for patients with conditions ranging from heart attack, heart failure, chronic obstructive pulmonary disease, asthma, lung cancer and other diseases. One such disease is COVID-19, which has had a disproportionately devastating impact on populations of color. In the early days of the pandemic, Black Americans were more than twice as likely to die of the disease as whites. Research indicates that pulse oximeter errors due to technical inaccuracies in reading darker toned skin have caused Black patients and other people of color disproportionately increased time to diagnosis of illness, delayed hospital admissions, and delayed access to lifesaving treatment,” the letter reads. “As pulse oximeters were designed and calibrated using lighter skin tones, they tend to overestimate the oxygenation of blood for people with darker skin tones—leading to an underestimation of their need for healthcare and exacerbating already serious risks.”

The FDA has been vocal about the limits of pulse oximeters. In 2021 the agency released a public safety communication about the same thing.

“The U.S. Food and Drug Administration is informing patients and health care providers that although pulse oximetry is useful for estimating blood oxygen levels, pulse oximeters have limitations and a risk of inaccuracy under certain circumstances that should be considered,” the communication stated. “Patients with conditions such as COVID-19 who monitor their condition at home should pay attention to all signs and symptoms of their condition and communicate any concerns to their health care provider.”

Kaul, and the other AGs applaud that communication, but they want more, including a warning label, similar warnings on other medical devices, and guidance to “health care providers about the risks and reduced efficacy of pulse oximeters for patients of color.”

“This issue highlights the importance of identifying disparities in the health care system and acting promptly to eliminate those disparities,” Kaul added.



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