A new dispute is arising in the quest for health equity, highlighting an unsuspected device, the pulse oximeter. On November 1, 2023, a total of 25 state attorneys general put forth a letter to the Food and Drug Administration (FDA), urgently requesting measures to resolve persistent inaccuracies of pulse oximeters. These inaccuracies pose enduring healthcare risks, specifically targeting people of color.
In this letter, the attorneys general expressed concern about several studies indicating that pulse oximeters, widely used for estimating blood oxygen levels, may display less accurate readings for people with darker skin. The inaccurate readings could lead to delayed or inappropriate medical care, increasing risks especially amidst the COVID-19 pandemic, where oxygen levels are a critical determinant of patients’ health status.
The FDA’s response to these complaints is perceived as inadequate by the attorneys general. The agency, which oversees medical device regulations, had issued a public notice in early 2021 about potential pulse oximeter inaccuracies but hasn’t pursued stricter measures like mandatory device recalibration since then.
The letter from the state attorneys general marks a significant stride in the fight for equal healthcare access and standards.
Read the details here.
The situation puts the spotlight on the pulse oximeter manufacturers, forcing them to address these glaring discrepancies. It also poses a question on the FDA’s role in safeguarding the health interests of all citizens, especially those who are traditionally marginalized in healthcare.