Roots Community Health and Medtronic Reach Pulse Oximeter Settlement

In a major victory for patient safety and health equity, Roots Community Health and Medtronic, a dominant leader in the pulse oximeter market, have reached a settlement that promotes awareness of how to use the device to ensure people with darker skin pigmentation are not denied care or undertreated due to elevated readings.

In a statement, Medtronic states, “it is pleased to announce it has reached an agreement with Roots Community Health 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 health equity can be achieved through technology, educational efforts, and partnerships.”

Medtronic is the first provider of pulse oximeters to hospitals to settle the lawsuit. Some other companies that distribute to consumers (Veridian Healthcare, Gurin Products, and Zewa) have also settled. The lawsuit continues against several other defendants.

“We are pleased that Medtronic, which holds a dominant share in the pulse oximeter market, has agreed
to prioritize patient safety by providing labels and brochures alerting their California hospital customers of the potential flawed readings for people with darker skin pigmentation,” said Roots CEO, Noha Aboelata, MD.

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

“Given how long these flaws have been known, other manufacturers should follow Medtronic’s lead and not wait for the FDA to act.”

Nearly a year ago, Roots sued Medtronic and a dozen other pulse oximeter manufacturers and distributors to halt the sale of the devices in California or force warnings to consumers and medical personnel of the flaws with the ubiquitous medical device.

The suit was filed based on substantial research that determined the devices often dangerously overestimate the blood oxygen levels of persons with darker skin. Additionally, a study by Roots, Sutter Health and others discovered that the inflated readings drove delays in care and differences in providing oxygen and other treatments.

The pulse oximeter reading is the only objective measure generally used to determine whether a covid patient will be taken to the emergency department, receive oxygen, or be admitted to the hospital. For their part, patients of color who purchased pulse oximeters for at-home use may have erroneously trusted their machines’ readings when deciding whether and when to seek professional intervention for the medical distress they were experiencing.

Widely used in all health care settings and available over-the-counter nationwide, pulse oximeters measure the amount of oxygen in a person’s blood to signal whether medical intervention is needed to treat people suffering from respiratory illnesses, like COVID.

During the deadliest days of the COVID pandemic, Roots’ clinical leadership noted death disparities for African Americans in the San Francisco Bay Area, even after controlling for underlying conditions and socioeconomic factors, and began searching for potential causes. African Americans in Alameda County, California, have died from COVID at twice the rate of whites.

Date: October 31, 2024
Contact: Terry Lightfoot | terry@rootscommunityhealth.org | 510.916.5201