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A medical device used to detect lower levels of oxygen in a person’s blood may be less effective for people with darker skin, and this could lead to delays in treatment and hospital admissions for people of color.
That concern is at the center of a letter to the U.S. Food and Drug Administration urging regulators to strengthen guidance and provide clear warning labels regarding the potential of incorrect pulse oximeter readings for patients of color.
Twenty-five state attorneys general, including Michigan’s Dana Nessel, submitted the letter Wednesday, Nov. 1. They call on the FDA to take immediate action to prevent further health risks to patients of color.
“A patient’s race should not be an obstacle to accurate and reliable medical diagnosis and treatment,” Nessel said in a prepared statement. “The FDA should require labels to alert users of pulse oximeters that they are not skin-color calibrated.”
Pulse oximeters are commonly used in physician’s offices and emergency departments to check individuals’ vital signs. When placed on a patient’s finger, it provides a quicker and less invasive way of measuring oxygen levels in the blood than having to draw blood and analyze it.
Blood-oxygen level readings are important for the diagnosis of conditions like heart attack, heart failure, chronic obstructive pulmonary disease, asthma, lung cancer, and COVID-19. Inaccurate readings can result in delayed care for patients who are in need of immediate medical attention.
A study published in the New England Journal of Medicine in 2020 found readings from the pulse oximeter indicated people with darker skin had more oxygen in their blood than was affirmed via a blood test.
Last fall, the FDA convened its Medical Devices Advisory Committee to address the negative impacts of the pulse oximeter on patients of color. Nessel and her peers commended the move, but pointed out no change was made to the device warning labels to protect individuals from harm in the year that followed.
“It is imperative that the FDA act now to prevent additional severe illness and mortalities among darker skinned people resulting from inaccurate or misleading pulse oximeter readings as well as inadequate diagnostic and treatment protocols and procedures,” reads a portion of the seven-page letter. “This is particularly critical as the nation moves from a declared coronavirus public health emergency to a still-dangerous endemic phase.”
Re-evaluating the pulse oximeter and understanding its role in creating racial disparities in health outcomes is part of a larger conversation going on in the medical community, explained Dr. Russell Lampen, medical director of infection prevention for Corewell Health in Grand Rapids.
It’s not just the pulse oximeter. It’s machines that measure bone density for osteoporosis treatment, or pulmonary function testing that gauges lung capacity, among others.
“There are a lot of things within medicine where race is sort of baked in and we don’t even realize it,” Lampen said. “There have certainly been efforts to look at where race may be hidden in plain sight as an inaccurate predictor of health care outcomes.”
Earlier this year, Lampen led a project at Corewell Health looking at at “race-based care algorithms,” which have in the past attributed health care outcomes to race when, in reality, they should be attributed to societal factors – things like access to health care, quality of food, air pollution, etc.
“For instance, within the clinical calculator for finding someone’s 10-year cardiovascular risk for heart attack, race is included,” he said. “But genetically‚ there’s no reason why African American individuals should be at higher risk of heart attack than white people.”
Corewell eliminated those race-based algorithms where possible, Lampen said. However there are some places – like the pulse oximeter – where there isn’t an equal alternative just yet.
Regarding the attorneys general letter to the FDA, Lampen called it a good first step, even if it’s “frustratingly not enough.” He wonders if it will force the envelope a bit, leading developers to come up with a better device that accounts for varying skin tones.
In the meantime, he noted the importance of caregivers being aware of the device’s deficiencies and using multiple means of assessment when a patient shows up in urgent care complaining of difficulty breathing.
“We know there’s a problem, we know we need to fix it, but we don’t have the data at our fingertips yet to fully address this,” Lampen said.
“I’m hopeful and I’m optimistic that as we begin to turn the lens inward on our own practices, that we can hopefully close some of those gaps and health care outcomes.”
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