Amid a national reckoning with racism fueled by the COVID-19 death rate of Black Americans, the U.S. Food and Drug Administration’s standards for pulse oximeters (those all-too-common devices that use light to measure blood oxygen saturation) “essentially ignore how skin color can affect the pulse oximeter reading,” according to the Johns Hopkins School of Medicine’s Bloomberg School in Health Policy and Management.
Accusing the medical community of ignoring the scientific literature while companies rush their products to market, critics of academic health policy argue that decisive regulatory action is needed to eliminate pulse oximetry bias.
WHY IT MATTERS
Because pulse oximeters use light to take readings in patients, the result for black Americans is an example of how racial bias creeps into medicine, Hopkins health policy experts said.
The U.S. Food and Drug Administration’s approval in the 1980s under the 510(k) review process has led to hundreds of approvals for pulse oximeters based on old designs with little regard for health equity or racial bias, the story published on monday.
While Guidelines for 2013 recommended pulse oximetry manufacturers include at least two “darkly pigmented subjects” in their premarket studies published in the New England Journal of Medicine In late 2020, it was discovered that black patients were three times more likely to have a significant discrepancy between pulse oximeter readings and arterial blood gas values.
Referring to the studyAccording to The State of Black America, Black Americans are twice as likely to die from COVID as white Americans.
Much of the blame can be traced to medical device manufacturers who have used light skin tones as the default for assessing pulse oximetry performance, according to Dr. Theodore Jack Iwashyna, an intensive care physician at Johns Hopkins and Bloomberg Distinguished Professor in Health Policy and Management at the Bloomberg School of Medicine.
“The reality is that functioning in white patients was considered the norm, while functioning in black patients was considered a clinical nuance that anesthesiologists and pulmonologists were expected to know about,” he said in the story.
Because the use of the technology is so ubiquitous – even to the point of remote patient monitoring via smartphone nearly 10 years ago – it is seen as a striking example of how systemic racism can impact health care and public health outcomes, according to a lawsuit filed by Roots Community Health Center in Oakland, California, to stop the sale of defective pulse oximeters.
THE BIGGER TREND
While a public meeting on November 1, 2022, to discuss concerns regarding the race and color bias of pulse oximeters began the process of redressing the harm (adverse health effects and deaths) that medical devices can cause in people of color, several state attorneys general wrote a letter to FDA Commissioner Dr. Robert Califf a year later urging action.
“It is imperative that the FDA take action now to prevent additional serious illnesses and deaths
among people with dark skin color due to inaccurate or misleading pulse oximeter readings and inadequate diagnostic and treatment protocols and procedures, they said in the letter.
The attorneys general also said they were concerned about the risks of integrating pulse oximeters into other diagnostic tools or medical technologies because their measurements are used to diagnose many conditions and diseases.
Large-scale digitization of their data could result in health care predictions based on historical pulse oximetry data with built-in color bias. This could lead to “recreation of racial health disparities.”
To reduce the varying performance of pulse oximeters, the agency is considering updating its 2013 recommendations for premarket clinical studies of these devices.
Advisers to the FDA’s Medical Devices Advisory Committee’s Anesthesiology and Respiratory Therapy Devices Panel have proposed new guidelines for clinical trials of pulse oximetry. In January, the agency’s approach to improving the performance of pulse oximetry devices was called for public feedback.
In the 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 relationship between pulse oximeter use and death cannot be established,” most adverse events were classified as malfunctions (91.5%), with 40% of the deaths citing problems with the pulse oximeter alarm system failing or the volume being set too low.
We have reached out to CDRH for an update and estimated timeline for next regulatory steps.
ON THE RECORD
“We are moving into an environment where we have to consider race in our approach to clinical care,” said Joseph Wright, health equity officer for the American Academy of Pediatrics, in the Hopkins story.
“In other words, we are acutely aware that bias can be an important driver of certain decisions around the delivery of care, or in this case, certain decisions around the use or approval of a particular technology.”
Andrea Fox is Editor-in-Chief of Healthcare IT News.
Email address: afox@himss.org
Healthcare IT News is a publication of HIMSS Media.