As the nation grapples with racial disparities over COVID-19 deaths among Black Americans, the U.S. Food and Drug Administration’s standards for pulse oximeters — the all-too-common device that uses light to measure oxygen saturation in the blood — “fundamentally ignore how skin tone can affect blood oxygen readings,” according to the Johns Hopkins Bloomberg School of Medicine’s School of Health Policy and Management.
While accusing the medical community of ignoring the scientific literature while companies rush to market, academic health policy critics argue that eliminating bias in blood oxygen saturation measurements requires drastic regulatory action.
WHY IT MATTERS
Because pulse oximeters use light to measure oxygen levels in a patient’s blood, the results for black Americans are an example of how racism permeates medicine, according to health policy experts at Hopkins.
After being approved by the U.S. Food and Drug Administration in the 1980s under the 510(k) review process, there are now hundreds of approvals for pulse oximeters based on older designs that pay little attention to health equity or racial bias, according to the paper published Monday.
While the 2013 guidance recommended that pulse oximeter manufacturers include at least two “darkly pigmented subjects” in their premarket studies, research published in New England Journal of Medicine In late 2020, it was found that black patients were three times more likely to have a significant discrepancy between their blood oxygen saturation readings and their arterial blood gas readings.
Citing research, State of Black America said black Americans are twice as likely to die from COVID-19 as white people.
Much of the blame can be traced to medical device manufacturers using light-skinned people as the default baseline for evaluating pulse oximetry performance, according to Dr. Theodore Jack Iwashyna, an ICU physician at Johns Hopkins University and Bloomberg Professor Emeritus at the Johns Hopkins Bloomberg School of Medicine.
“The reality is, function in white patients is considered the norm, while function in black patients is considered a clinical nuance that anesthesiologists and pulmonologists are expected to know,” he said in the article.
Because the technology is ubiquitous — even making its way into remote patient monitoring systems via smartphones nearly 10 years ago — it is seen as a prime example of how systemic racism can impact health care outcomes and public health, according to a lawsuit filed by the Roots Community Health Center in Oakland, California to stop the sale of defective pulse oximeters.
THE BIGGER TREND
A November 1, 2022, public meeting to address concerns about racial and ethnic bias in pulse oximeters began the process of addressing the harms, adverse health events, and deaths that medical devices can cause for people of color. A year later, several state attorneys general wrote to FDA Commissioner Dr. Robert Califf urging action.
“FDA must act now to prevent further serious illness and death in people of color due to inaccurate or misleading blood oxygen measurements and inadequate diagnostic and treatment protocols and procedures,” they wrote in the letter.
The attorneys general said they were also concerned about the risks of integrating pulse oximeters into other diagnostic tools or medical technology, since their readings are used to diagnose a wide range of conditions and diseases.
Mass digitization of data could make health care predictions based on historical blood oxygen saturation data with color bias that could “cause racial health disparities.”
To reduce inconsistent performance of pulse oximeters, the agency is considering updating its 2013 recommendations for clinical studies before these devices are marketed.
FDA advisers from the Anesthesia and Respiratory Therapy Devices Committee of the Medical Devices Advisory Committee have proposed new guidance for pulse ox clinical trials. Public comment responses on the agency’s approach to improving the performance of pulse ox devices will be submitted in January.
In the executive committee’s summary — prepared for a February meeting at the FDA’s Center for Devices and Radiological Health — the panel noted that, while “the reports came from seriously ill patients and a causal link between pulse oximeter use and death could not be established,” most adverse events were classified as malfunctions — 91.5 percent — with 40 percent of death reports citing problems related to malfunctioning blood oxygen alarms or too-low volume settings.
We reached out to CDRH for an update and estimated timeframe for the next regulatory steps, and on Friday, an FDA spokesperson responded that revising the FDA guidance listed in the CDRH Guidance Program is a top priority with the goal of publishing it in fiscal year 2024, which ends September 30, according to the U.S. Treasury Department.
“The FDA gathered information from stakeholders, solicited input from ongoing clinical studies to inform its decision, and evaluated all available information regarding factors that may affect the accuracy and performance of pulse oximeters,” the spokesperson added.
“FDA will notify the public when important new information or recommendations become available.”
ON PROFILE
“We are moving into an environment where our approach to clinical care must be race-informed,” Joseph Wright, chief health equity officer for the American Academy of Pediatrics, said in the Hopkins article.
“In other words, we are well aware that bias can be part of the root cause of particular decisions related to the delivery of care or, in this case, particular decisions related to the use or adoption of a particular technology.”
This story was updated on July 12, 2024, with the FDA’s response and an estimated time frame for updating the guidance.
Andrea Fox is senior editor of Healthcare IT News.
Email: [email protected]
Healthcare IT News is a publication of HIMSS Media.
