Errors with common medical device led to 5-hour delay in COVID treatment for Black patients: study

OAKLAND, Calif. (KGO) -- As we continue to navigate the tripledemic of COVID-19, RSV, and the flu, local health leaders are raising concerns over a key medical device that often determines if a sick patient is hospitalized or not.

Sutter Health and Oakland-based Roots Community Health Clinic argue in a paper recently published in the American Journal of Epidemiology that a device that measures the amount of oxygen in your blood may not be accurate for patients with darker skin tones and that key difference leads to a five hour delay in treatment for Black patients.

It's a device used in practically every healthcare setting in America from emergency rooms, to ambulances, and doctors offices: the pulse oximeter.

The device fits around the tip of your finger and painlessly measures the amount of oxygen in your blood.

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"The technology itself appears to be flawed and does not take into account skin tone," said Dr. Noah Aboelata.

Dr. Aboelata is the founder and CEO of the East Oakland based Roots Community Health Center. She co-authored the paper published in the Journal of Epidemiology that highlighted inaccuracies in the pulse ox devices and the alarming impact.

"We think of our tools as being unbiased and very objective, but when we found out that this tool in and of itself was biased, and was showing readings in the normal range more frequently for darker skinned people, when in fact, their oxygen was below the normal range, that is just devastating," said Aboelata.

Think back to the early days of the pandemic - when hospitals were overflowing with COVID patients. A person's oxygen reading determined if they received supplemental oxygen, which was in scarce supply.

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A patient's blood oxygen level was one of the only objective measures from the CDC to determine if someone should be admitted to the hospital. Patients with a 95% blood oxygen reading or above were routinely discharged from the hospital. Those with a 94% reading or below were admitted and placed on oxygen.

A 1% difference impacted a patient's treatment.

"Everything is at stake," said Dr. Stephanie Brown. "The oxygen reading in the blood determines your treatment trajectory for COVID."

Dr. Brown serves as clinical lead for Sutter Health's Institute on Advancing Health Equity. She joined Dr. Aboelata as a co-author on the paper.

Brown saw the impacts of the device's alleged inaccuracies firsthand working in the ER at Sutter Health's Alta Bates Medical Center in Oakland.

"To see someone in front of my face, who looks to be working harder to breathe, and seems to be sicker than what I see in front of me. That's a tough kind of mind game to play on a daily basis," said Brown.

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Both doctors believe the devices potentially contributed to the higher COVID-19 death rate for Black patients when compared to white patients.

Take Alameda County for example, where Black people have died of COVID-19 at nearly twice the rate as white people.

"There's no doubt in my mind that this faulty device has led to death," said Dr. Aboelata.

Doctors Aboelata and Brown are now calling on the device manufacturers to improve accuracy for darker skinned patients.

They're also calling on the manufacturers to warn people of the inaccuracies since the devices are sold directly to consumers at local drugstores.

"Are you actually willing to go to court to block these manufacturers from selling these devices in California?" asked ABC7 News Race and Culture Reporter Julian Glover.

"Absolutely. We know that this has to be fixed," Dr. Aboelata responded.

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There is an additional procedure to measure to the amount of oxygen in the blood called an arterial blood gas (ABG). The ABG is a blood test that draws blood from an artery, typically in a patient's wrist. However, the procedure can be painful, and due to the shortcomings of the pulse oximeter devices darker-skinned patients are unfairly subjected to a more painful screening, which isn't fair, Dr. Brown argues.

We reached out to a dozen leading manufactures of the pulse oximeter devices for comment and heard back from two.

Irving, California based Masimo released a statement to ABC7 News saying in part:

Masimo is very interested in and, applauds the efforts of Sudat, el. in addressing this topic. Further, we, at Masimo, have been interested in solving the confounders to pulse oximetry for 3 decades. We invented SET 3 decades ago, and this helps improve signal quality and decrease noise due to movement, low perfusion, and static absorbers including melanin and skin pigmentation.

Despite our already excellent accuracy and performance in all skin tones, we are committed to continuing to improve our pulse oximeter devices and sensors and now have RD Set which has no clinically significant difference between dark and light skin tone.

CVS Health released a statement to ABC7 News saying:

We're committed to ensuring the products we offer work as intended, comply with all laws and regulations, and satisfy customers. This includes our work to advance health equity for our customers and patients by improving health care access and quality of health for every population we serve. We're closely monitoring FDA guidance regarding pulse oximeters and coordinating with our suppliers as proposals for new standards emerge. We'll carefully review any forthcoming FDA recommendations that apply to retailers selling over-the-counter pulse oximeters.

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