Americans learned a lot through the pandemic about health care inequities. According to the National Library of Medicine, Black Americans had a higher COVID-19 mortality rate than all other ethnic groups surveyed at the height of the crisis in 2020.
But that was not the only inequity highlighted. A small medical device called a pulse oximeter reads how much oxygen is in the blood, but their effectiveness has been called into question by a U.S. Food and Drug Administration advisory committee.
Studies show the medical device may yield inaccurate readings in patients with darker skin tones.
“I am off to Fresenius Kidney Care,” said Ruth Verbal, a kidney disease patient.
Three days a week, she laces up her sneakers and heads to an appointment to sit on a dialysis machine for three to four hours.
“I have end-stage renal kidney disease, and my kidneys are failing. Until I can get a transplant, dialysis is my choice of treatment," Verbal said.
Over the past 30 years of battling kidney disease, Verbal has learned the importance of advocating for her health, especially as a patient of color.
“When I go for my checkups, they check my pulse oximeter. But I never knew that the machine itself could give an inaccurate reading based on the color of my skin,” she said.
An FDA committee reviewed studies that found pulse oximeters may give less accurate readings for people with darker skin tones.
“That's alarming a little bit because maybe it's wrong," Verbal said. "You know, maybe it's, I'm having a good pulsating, and they're telling me that I don't.”
Some medical experts warn that if the device isn’t calibrated for darker skin tones, the pigmentation of the skin could affect how the light is absorbed by the sensor, leading to flawed oxygen readings and worse, the discharging of patients that may need medical attention.
Pulse oximeters detect oxygen levels without having to take a blood sample. During the height of the pandemic, overwhelmed hospitals used the devices to determine oxygen levels in COVID-19 patients, and ultimately, to help make decisions about care. What researchers have found is that relying on the technology and the potentially flawed readings may have contributed to greater deaths among Black and other patients.
Also, Apple is facing a class action lawsuit that alleges its blood oxygen reader in the device yields inaccurate results for people of color. The Blood Oxygen app allows people to measure their blood oxygen level directly from their wrist. The suit was filed last week on behalf of plaintiff Alex Morales in New York. He alleges that when he bought the Apple watch, it would read blood oxygen level, regardless of skin tone.
While family medical physician Dr. Jose David said he has not noticed a difference in readings between patients, he said darker nail polish can affect the oximeter’s accuracy.
“When we check vital signs for patients, we always use the pulse oximeter oximetry,” he said.
The FDA panel discussed technical changes that can be made, and whether the medical devices should have labels. It warned that inaccurate readings may be associated with skin color.
A 2022 study of more than 3,000 hospitalized people found that Asian, Black and Hispanic patients received less supplemental oxygen than white patients.
So when Ruth heads off to her next appointment, she’s going to make sure she asks all the right questions.
“It's not just in the hands of your medical providers, it's also in your hands," she said. "So take care of you by asking questions.”
The FDA is looking into the matter, but did the issue really came to the forefront during the pandemic?