Medtronic settled a lawsuit claiming its pulse oximeters may provide less accurate readings for people with darker skin pigmentation.

Roots Community Health, based in Oakland, California, filed a lawsuit against Medtronic and 12 other companies last year, citing studies that found pulse oximeters often overestimate blood oxygen levels in people with darker skin. Another study by Roots, Sutter Health and the University of California, San Francisco, found that Black COVID-19 patients could have delayed treatment due to inaccurate readings.

Medtronic agreed to provide labels and brochures to California hospital customers about the potential for flawed readings on people with darker skin pigmentation, Roots CEO Noha Aboelata said in a statement. The companies did not disclose the full terms of the settlement. 

The company said in an emailed statement it “looks forward to working with Roots, the [Food and Drug Administration] and other key stakeholders to ensure health equity can be achieved through technology, educational efforts and partnerships.”

Medtronic is the only maker of FDA-approved pulse oximeters to settle, according to the company’s statement. Three companies that distribute products to customers, Veridian Healthcare, Gurin Products and Zewa, have also settled. 

Other defendants include Masimo, which makes FDA-approved pulse oximeters; GE Healthcare, which makes patient monitoring systems that include pulse oximetry technology; and CVS and Walgreens, which sell over-the-counter pulse oximeters that are not cleared by the FDA.

Medtronic holds a dominant share in the market for pulse oximeters, Aboelata said. 

“Ultimately, we want the FDA to hold themselves and manufacturers accountable for ensuring the devices work for everyone and should act swiftly,” Aboelata said. “Short of that, these steps by Medtronic will help medical personnel evaluate readings which can be artificially high for people with darker skin pigmentation.”

FDA guidance delayed

The FDA’s device center has been discussing how to handle accuracy concerns with pulse oximeters since it first flagged problems in 2021 after use of the devices increased during the COVID-19 pandemic.

The agency listed draft guidance on performance testing, labeling and premarket submission requirements for the devices as a priority for fiscal year 2024, which ended in September. Having missed that cutoff, the agency now lists it as a priority for fiscal year 2025. 

FDA spokesperson Kristina Wieghmink wrote in an email that the agency has been working to update its 2013 final guidance on pulse oximeters and is “committed to issuing these new draft recommendations as expeditiously as possible.”

The FDA published a discussion paper on the devices in November 2023 and requested public comments. The agency also held an advisory committee meeting in February.

The committee supported increasing clinical trial participants from 10 people to at least 24. They also agreed that participants in clinical trials should span the Monk Skin Tone scale, a measurement developed by Ellis Monk, an associate professor at Harvard University, that is designed to represent a broader range of skin tones.

The committee also said over-the-counter pulse oximeters should meet the same requirements as prescription devices.

For non-compliant pulse oximeters that are already being sold, some participants asked about labeling changes, adding black box warnings or removing the devices altogether.