The study showed that errors in common medical devices led to a 5-hour delay in treating COVID-19 for black patients

Oakland, California (KGO) – As we continue to navigate the triple pandemic of COVID-19, RSV, and influenza, local health leaders are raising concerns about a key medical device that often determines whether or not a patient is hospitalized.

Sutter Health and the Roots Community Health Clinic in Oakland argue in research recently published in the American Journal of Epidemiology that the device that measures the amount of oxygen in your blood may not be accurate for dark-skinned patients and that the key difference results in a five-hour delay in treatment for black patients.

It’s a device used practically everywhere in healthcare in America from emergency rooms to ambulances and doctors’ offices: the pulse oximeter.

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

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“It seems that the technology itself is flawed and does not take into account skin color,” said Dr. Noah Abu Atta.

Dr. Abu-Ata is the founder and CEO of Roots Community Health in East Auckland. She co-authored the paper published in the Journal of Epidemiology that highlighted inaccuracies in pulse ox devices and the disturbing effect.

“We think our tools are very unbiased and objective, but when we found out that this tool itself was biased, and was frequently showing readings in the normal range for darker-skinned people, when in fact, their oxygen was lower than normal, that’s devastating. “.

Think back to the early days of the pandemic – when hospitals were overflowing with COVID patients. A person’s oxygen reading determined if they were receiving supplemental oxygen, which used to be scarce.

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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 hospitalized. Patients with a blood oxygen reading of 95% or higher are routinely discharged from the hospital. Those with a reading of 94% or less were admitted and placed on oxygen.

A difference of 1% affected the patient’s treatment.

“It’s all at stake,” said Dr. Stephanie Brown. A blood oxygen reading determines the course of your treatment for COVID.

Dr. Brown serves as Clinical Lead for the Sutter Health Institute to Promote Health Equity. She joined Dr. Aboul-Atta as a co-author on the paper.

Brown saw the device’s alleged bug effects firsthand in the emergency room at Sutter Health’s AltaPits Medical Center in Oakland.

“To see someone in front of my face, they seem to be working even harder to breathe, and they look sicker than I see them in front of me. It’s a tough mental game that you play every day,” Brown said. .

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Both doctors believe the two devices may have contributed to the higher COVID-19 death rate for black patients compared to white patients.

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

“I have no doubt that this defective device has led to death,” said Dr. Abu al-Ata.

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

They also call on manufacturers to warn people about inaccuracies because the devices are sold directly to consumers at local pharmacies.

“Are you actually willing to go to court to stop these manufacturers from selling these devices in California?” asked ABC7 News Race and Culture reporter Julian Glover.

Dr. Abu Atta replied, “Absolutely. We know this needs to be fixed.”

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An additional procedure to measure the amount of oxygen in the blood is called an arterial blood gas (ABG). An ABG test is a blood test that draws blood from an artery, usually in the patient’s wrist. However, the procedure can be painful, and because of deficiencies in pulse oximeter devices, darker-skinned patients are subjected to a more painful examination, which is not fair, says Dr. Brown.

We reached out to dozens of leading pulse oximeter manufacturers for comment and heard back from two.

Massimo in Irving, California issued a statement to ABC7 News saying in part:

Massimo is very interested and commends the efforts of Sudat, el. in addressing this issue. Moreover, we, at Masimo, have been interested in solving the bewildering issues of pulse oximetry for 3 decades. We invented SET 3 decades ago, this helps improve signal quality and reduce noise due to movement, reduced perfusion, and static uptake including melanin and skin pigmentation.

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

CVS Health released a statement to ABC7 News saying:

We are committed to ensuring that the products we offer work as intended, comply with all laws and regulations, and satisfy customers. This includes our work to promote health equity for our clients and patients by improving access to health care and the quality of health for all of the populations we serve. We closely monitor FDA guidance for pulse oximeters and coordinate with our suppliers when proposals for new standards arise. We will carefully review any upcoming recommendations from the Food and Drug Administration (FDA) that apply to retailers that sell over-the-counter pulse oximeters.

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