Writing for Modern Healthcare, Kara Hartnett explains how certain medical devices are less accurate in minority patients, and details the steps researchers, health systems, trade associations, and health agencies are taking to address these racial biases. 

An ecosystem approach to achieving diversity in clinical trials

How certain medical devices create disparities

A growing body of evidence suggests that certain medical devices commonly used to evaluate patients produce racially biased results, leading people of color to receive inconsistent results.

According to Hartnett, "[s]ome medical devices generate racial bias in their results—such as pulse oximeters and infrared thermometers—largely because they weren't tested on diverse groups of people prior to going to market."

In a recent study from Emory University, researchers used forehead thermometers that had already been tested in over 100 clinical studies to measure the body temperature of Black patients. The researchers found that there was a 26% lower chance of detecting a fever in Black patients with forehead thermometers than if an oral thermometer had been used.

Notably, there was no discrepancy for white patients, suggesting a disparity in the way forehead thermometers measure temperatures in patients with different skin tones. "Missed fevers could lead to delays in diagnoses, delays in antibiotic treatments and increased death rates among Black patients," Hartnett writes.

"This is an important finding because health systems routinely use fever cut-offs to alert or notify team members about care pathways, such as sepsis alerts to deliver timely triage and antibiotics. If fevers are going undetected, then alerts are not being activated," said Sivasubramanium Bhavani, an assistant professor at the Emory University School of Medicine and an author of the study.

In a separate study by the University of Michigan Hospital, researchers found that pulse oximeters overestimate blood oxygen levels in patients who have darker skin, potentially delaying necessary treatment and putting patients at risk.

According to the study, pulse oximeters are three times less likely to detect abnormally low concentrations of oxygen in Black patients' blood.

"Oxygen is among the most frequently administered medical therapies, with a level that is commonly adjusted according to the reading on a pulse oximeter that measures patients' oxygen saturation," wrote the study authors. "Questions about pulse oximeter technology have been raised, given its original development in populations that were not racially diverse."

In addition, some medical devices include antiquated race-based guidelines or adjustments. An article in the New England Journal of Medicine highlighted that the processes for X-rays previously included a race adjustment that exposed Black patients to higher radiation levels.

According to Hartnett, these guidelines were based on "the false belief that Black people have denser bones, bigger muscles and thicker skin." While the race adjustment is no longer used, it was widely practiced throughout the 1960s—and its legacy can be found in other products.

"Fuller knowledge of the harms of simplistic race classifications can help prevent future mistakes with race adjustment," wrote Harvard University science historians Itai Bavli and David Jones. "Such prevention is no small challenge. Racist biases are often implicit and unnoticed. By continuing to document the misuse of race in medicine, we can help protect patients from medical racism and work toward health justice."

How industry leaders are addressing racial biases in medical devices

Now, researchers, health systems, trade associations, and health agencies are taking steps to address racial disparities created by medical devices.

For example, Brigham and Women's Hospital has tasked their quality and safety team with combatting racial bias in medical devices. Esteban Gershanik, the hospital's medical director for quality, safety, and equity, said after their team learned that pulse oximeters are less effective on Black patients, it taught clinicians how to correct it in their clinical practices. In addition, the hospital incorporated the findings into its EHRs.

"It's a matter of ensuring that we evaluate these levels of potential biases throughout the system," Gershanik said. "As greater scrutiny will come to these devices, we will also have that fall under our department of quality and safety, to understand if there's any discrimination or bias when we look at patient safety or quality issues, or experience issues as well."

Notably, the hospital has also partnered with the American Medical Association and the Joint Commission on a quality and safety peer network that will exchange information about discrimination or biases that impact patient safety and explain how these issues can be solved.

In addition, FDA now requires device applications to report the demographic breakdowns of their clinical trials.

In November, the agency's Anesthesiology and Respiratory Therapy Devices Panel will hold a discussion on racial bias found in pulse oximeters. At the meeting, the group will attempt to assess and understand the relationship between skin pigmentation and oximeter accuracy.

"The FDA has been working on additional analysis of premarket data, as well as working with outside stakeholders, including manufacturers and testing laboratories, to analyze additional post market data to better understand how different factors including skin pigmentation may affect pulse oximeter accuracy," the agency wrote in the meeting notice. (Hartnett, Modern Healthcare, 9/26)