In 2022, Noha Aboelata noticed something disturbing. As the founder and CEO of a health clinic serving a predominantly black and brown population, she realized that the racial biases built into pulse oximeters were hurting her patients in Oakland, California. The devices overestimate blood oxygen in dark-skinned people, making them appear healthier than they are.
So she decided to pressure companies to create a fairer device 12 manufacturers and distributors of pulse oximeters are being sued.
That lawsuit, filed nearly a year ago, is starting to bring about change. Several companies, including Medtronic, have reached settlements. Although companies have not disclosed the exact terms of the settlements, Medtronic has begun educating physicians about the shortcomings of its devices and providing QR codes on its devices that link to educational information about pulse oximetry.
“It’s definitely a step in the right direction — labeling is really needed here — but I don’t think it goes far enough,” said Sara Gerke, a law professor at the University of Illinois College of Law. “We need to design better products that work for everyone.” To that end, Medtronic has also opened a lab in Colorado with the aim of testing future devices on a more diverse range of skin tones.
Pulse oximeters, which measure blood oxygenation by shining light through a patient’s skin, have long been known to be less accurate in darker pigmented skin. But the public became much more aware of their restrictions during the height of the pandemic, when they made it harder for health care workers to assess the severity of Black patients’ Covid-19 cases. That, coupled with a desire to address medicine’s racial disparities, put a spotlight on their failures.
The lawsuit alone cannot solve the problems with pulse oximeters. Several senators urged the FDA to address the issue, and in 2022 the agency held a public meeting calling for clearer labeling and stricter testing of the devices. The following year, more than two dozen attorneys general doubled down on calls for changes to the devices, citing STAT reporting.
Today, those who rely on the devices in emergency rooms and ICUs are still waiting for the FDA and are angry about the delay. “I should have had a better device by now,” Theodore J. Iwashyna, a pulmonologist and critical care physician at Johns Hopkins who has been studying the devices’ effect on dark-skinned patients since 2020, recently told STAT. “How many more of my patients have to die before we solve this?”
Aboelata, a general practitioner, is also frustrated by the pace of change. She was part of a study from a nearby health care system that when pulse oximeters overestimated blood oxygen levels in Black patients with Covid, they waited longer to be treated. be seen and treated by a doctor. Her clinic’s lawsuit accused manufacturers and distributors of the device of violating California consumer protection laws, arguing that companies falsely advertised the efficacy of their devices.
Several other companies that distribute and sell oximeters, including Veridian Healthcare, Gurin Products and Zewa, have settled with Roots Community Health, Aboelata’s clinic. Medtronic is the first company to sell oximeters specifically to hospitals to settle the lawsuit. CVS Pharmacy, Walgreen, Compass Health Brands, Contex Medical Systems USA, Einstein Associates, ChoiceMMed America, Masimo, Covidien Sales and GE Healthcare have yet to settle.
“We are pleased that Medtronic, which has a dominant share of the pulse oximeter market, has agreed to prioritize patient safety by providing labels and brochures alerting their hospital customers in California to the potentially flawed readings for people with dark skin pigmentation ,” Aboelata said in a statement.
Medtronic said in a statement that it is “pleased to announce that Roots Community Health has agreed to dismiss claims against the company related to pulse oximeters. Medtronic looks forward to working with Roots, the FDA and other key stakeholders to ensure healthcare equity can be achieved through technology, educational efforts and partnerships.”
Although the lawsuit would only apply in California, changes made in the state are often adopted nationally due to its large market share.
Now Roots and other experts STAT spoke to are waiting for an update to the FDA guidelines, which they hope will lead to devices that work well on all skin tones. “There is something problematic about a system that has a good tool for lighter-skinned patients and a bad tool for darker-skinned patients,” said Carmel Shachar, a law professor at Harvard Law School. “So education will help raise awareness of this problem, but it won’t necessarily help a doctor figure out, ‘What should I do with my dark-skinned patient?’ That’s where the FDA guidelines would come in.”
Thomas Valley, a pulmonologist at the University of Michigan, who did just that studied the problems with oximetersnoted that the FDA has turned off a warning about the inaccuracies of the device. “You could say it wasn’t that effective because we still have problems,” he said. “A broad warning does not necessarily get through to all the people who really need to know about it.” He also pointed out that several of the “big players” have yet to establish themselves.
The FDA was supposed to update its guidance on devices by September 30, but missed that target date.
The agency has said it is “working diligently” to issue the new guidelines, stressing that they are best practice recommendations for drug manufacturers, not requirements.
“I am happy with any progress, but ultimately the machines need to be repaired,” Aboelata told STAT. “It’s actually just a small part of it. I really hope it’s a catalyst. I really hope it helps raise awareness across the board, but I think we are still a long way from any justice on this issue.”
This story has been updated to clarify that the label Medtronic added to its devices is a QR code that leads to educational materials about pulse oximeters.