Noha Aboelata, director of Roots Community Health Center in Oakland, California, is pursuing a lawsuit against twelve companies for the sale of pulse oximeters. According to researchers, they inaccurately measure the amount of oxygen in the blood of black people. Scientists say the devices overestimate blood oxygen values in dark-skinned individuals, leading healthcare professionals to make poor treatment decisions. The statements, which mark the beginning of a long judicial path, were included in an article published in the journal Nature to which the UNQ Scientific News Agency had access.
Specifically, Aboelata and his colleagues are calling for future sales of the devices to be banned in California until they provide accurate readings for affected people, or until warning labels are placed to point out their inaccuracies.
Pulse oximeters, when placed on the tips of the fingers, determine the level of oxygen in the blood thanks to a light that passes through the skin. The measurement is part of a person’s vital signs and provides information for health professionals to act quickly. However, the high amount of melanin present in dark-skinned people interferes with this determination.
Although this issue came to light during the coronavirus pandemic, the judicial process is moving at a slow pace. However, this disappointment is combined with hope: the team of experts believes that the lawsuit could have a domino effect, starting in California and spreading to the entire country.
All of the defendant companies defend their technology by stating that they always passed the performance tests established by the United States Food and Drug Administration (FDA). Masimo, one of the defendant manufacturers, points to a paper published by its research division in which they found no significant differences in blood oxygen readings for white and black people. However, medical researchers from Johns Hopkins Medicine in Baltimore reviewed this work and warned that only healthy volunteers were studied and that the trial should be extended to clinical settings.
As the scientists explain in the Nature magazine article , the devices were developed with studies on white people and the problem of inaccurate measurements came to light with massive use during the pandemic. Although biases of this type have been known for a long time, it was highlighted in a paper published in 2022 where the authors showed that black people were three times more likely than white people to receive pulse oximeter readings in a “safe” range. ” when, in fact, their blood oxygen levels were dangerously low. The study caught Aboelata’s attention since Roots is a nonprofit organization that primarily provides health care to individuals with dark skin.
Since these facts reached public opinion, several senators urged the FDA to focus on the issue. Meanwhile, Aboelata also investigated the treatment patients received at a Northern California health care system. She and her colleagues confirmed that pulse oximeters overestimated the blood oxygen levels of black people in that system and this correlated with them receiving less medical care or having to wait longer for it.
Roots sent a letter to the companies that make or sell the devices, asking them to fix them or at least label them with a warning. When no response was received, the lawsuit was filed. The healthcare industry must take responsibility for systemic inequalities in healthcare, Aboelata says.
