The attorney general of Wisconsin has joined the attorneys general of 25 other states in a lawsuit addressed at the FDA over deficiencies in pulse oximeter inaccuracies. According to the latest AG’s statement, these devices pose an undue risk of underdiagnosing or misdiagnosing individuals of color.
Pulse oximeters are a medical device invented in the 1980s intended to measure the blood oxygen levels of a patient. These devices are the only rapid and noninvasive methods for measuring oxygen saturation in the blood. Some conditions that can be diagnosed through pulse oximeter data include heart failure, sleep apnea, and respiratory complications.
Pulse oximeter usage jumped sharply during the height of the COVID-19 pandemic when oximeters were used as a preliminary tool to determine the type of care a patient would receive. Importantly, when resources were under heavy duress, the results of a pulse oximeter test could be the difference between a patient being admitted to the hospital or being sent home. It has been known for decades that people with darker skin tones can have reduced accuracy when their oxygen saturation is measured with a pulse oximeter.
According to the 26 attorneys general lawsuit, the inaccuracies of pulse oximeters with regard to people of color have led to real harm due to medical misdiagnosis. Inaccurate pulse oximeter readings can lead to delays in treatment or hospital admission that can lead to significant differences in health outcomes.
According to the statement from the Wisconsin attorney general, Josh Kaul, “Researchers have known for decades that darker skin tones could reduce a pulse oximeter’s accuracy, but the COVID pandemic led to a significant increase in evidence and wider awareness of the implications of this bias.”
These attorneys general have noted that these legal actions come on the one-year anniversary of the FDA’s Medical Devices Advisory Committee’s convening to address concerns related to the pulse oximeter’s race and color biases.