A new study by the Johns Hopkins Bloomberg School of Public Health highlights a slow progression in the diversity of testing for pulse oximeters, despite FDA recommendations.
These devices, crucial for measuring blood oxygen levels, have shown discrepancies in accuracy when used on darker skin, leading to potential health risks for non-white patients, according to the study.
In 2013, the FDA advised manufacturers to test pulse oximeters on a variety of skin tones to combat this issue. However, recent findings indicate only a modest increase in adherence to these guidelines: compliance rose to 25% after the guidance from a mere 4.1% beforehand, the study states.
Pulse oximeters are increasingly used both in healthcare settings and at home, a trend that surged during the COVID-19 pandemic. Despite their widespread use, the FDA’s process for clearing these devices — which involves comparing them to previously approved models — shows that inclusivity in testing remains lacking, according to Johns Hopkins.
The research, published in JAMA, points out the inadequacy of voluntary guidelines in resolving biases inherent in pulse oximetry.
RELATED | One for the Road: Are your pulse ox readings messed up?
“Our findings underscore the limits of voluntary guidance alone for solving bias in pulse oximeters,” says study lead author Kadija Ferryman, PhD, an assistant professor in the Bloomberg School’s Department of Health Policy and Management and the Berman Institute of Bioethics. “The FDA’s new draft guidance is a step in the right direction, but others, including manufacturers, healthcare organizations and other organizations committed to patient safety can contribute to addressing this bias.”
In their recent study, Ferryman and her team analyzed how well manufacturers followed this FDA recommendation. They sifted through an FDA database for product clearance summaries of pulse oximeters, pulling out a total of 767 summaries spanning from 1996 to 2024, according to Johns Hopkins. The team then evaluated these summaries, focusing on whether they mentioned any of 17 specific terms related to race, ethnicity or skin color during three key periods: before the guidance (1996–2012), shortly after the guidance was issued (2013–2015), and following the guidance (2016–2024).
They discovered that only 17 of the 412 documents (4.1%) from the pre-guidance period, 12 of 87 documents (13.8%) around the time of the guidance, and 67 of the 268 documents (25.0%) from the post-guidance period mentioned any of the specified terms, according to Johns Hopkins. These findings indicate that while the FDA’s guidance did influence manufacturer practices, the effect was modest. A significant majority of the summaries from after the guidance still did not address issues of skin tone or diversity in testing.
This discussion is further expanded in a JAMA Viewpoint article, describing the challenge of bias in pulse oximeters as a complex, stubborn issue without straightforward solutions. The latest guidance from the FDA, which remains open for public comment until March 10, seeks to enhance testing protocols by advocating for a more representative sample of participants, Johns Hopkins noted.
The research emphasizes the necessity for proactive engagement by all stakeholders involved in healthcare to ensure the safety and efficacy of medical devices across diverse populations. This study was supported by a Nexus Research Award from Johns Hopkins University and serves as a critical call to action for improving medical device testing standards.
