Efforts to fix bias and accuracy problems with pulse oximeters have an uncertain future under the Trump administration.

After years of concerns that pulse oximeters may provide less accurate results for people with dark skin pigmentation, the Food and Drug Administration issued a draft guidance in January clarifying requirements for the devices. However, experts are concerned the guidance may not move forward under the Trump administration.

“I hope that the new administration will recognize that pulse oximeter bias is a problem, and that if addressed, could improve healthcare for many Americans,” Kadija Ferryman, an assistant professor of health policy and management at Johns Hopkins University, wrote in an email. 

Ferryman added that the new guidance for performance testing standards “could result in more accurate devices, and thus better devices, which is good for everyone.”

Pulse oximeters are small devices that use light to estimate the amount of oxygen carried in the blood. Several recent studies — and papers dating back as early as 1990 — have found that pulse oximeters overestimate oxygen saturation in people with dark skin pigmentation.

The problem gained attention during the pandemic when an analysis by Johns Hopkins researchers found that overestimation of oxygen saturation led to delays in Black and Hispanic patients being eligible for COVID-19 therapies.

Jenna Lester, an associate professor of dermatology at the University of California, San Francisco, said in an interview that the guidance should be updated more frequently, and the chance that it might not be finalized is “definitely a concern.”

Lester, who established UCSF’s Skin of Color program, said many of her patients are aware of the issue and ask about it.

“So many people have questions,” Lester said, “and it makes them apprehensive, like, is this device going to work for me?”

The Trump administration’s stance against diversity, equity and inclusion programs raises questions about whether the guidance will advance. President Donald Trump, on his first day in office, signed an executive order calling for agencies to end all “diversity, equity, inclusion and accessibility” policies and programs. A federal judge blocked some portions of the executive order in late February, finding the directives undermined free speech and were unconstitutionally vague.

Martin Makary, Trump’s pick to lead the FDA, did not answer questions about the removal of an FDA draft guidance on clinical trial diversity and the Office of Minority Health and Health Equity’s website in a Thursday confirmation hearing. 

“I believe in common sense and I believe in clinical trial diversity both, and so I believe if you're going to make results extrapolated to the general population, you should have results in those populations that you make the recommendations for,” Makary said when asked about the importance of clinical trial diversity.

The FDA and the Department of Health and Human Services did not respond to questions about whether the FDA will finalize the guidance and whether Trump’s executive order applies.

The comment period for the FDA’s draft guidance closes on March 10.

Michael Abrams, a researcher with consumer advocacy nonprofit Public Citizen, said in an email, “If the guidance gets stonewalled, that would be a setback to a process that already is moving at a glacial pace.”

A ‘step in the right direction’

The FDA’s draft guidance clarified requirements for pulse oximeters, increasing the number of recommended study participants from a minimum of 10 people to 150, and provided more specifics on evaluating devices across a range of skin pigmentation.

The agency also proposed listing all FDA-cleared pulse oximeters that have demonstrated accuracy regardless of skin pigmentation.

Ferryman wrote that the guidance was a “step in the right direction that will hopefully include more people with diverse skin pigmentation in performance testing of pulse oximeters.”

In submitted comments, patient safety nonprofit ECRI and researchers at Johns Hopkins called for postmarket review, noting that premarket testing in predominately healthy volunteers may lead to less relevant results.

Julian Goldman, a medical director of biomedical engineering at Mass General Brigham, said that low perfusion, or reduced blood flow, was also associated with the inaccurate readings for people with dark skin pigmentation. Some laboratories will screen out people with low perfusion or will warm study participants’ hands to ensure they have good perfusion, he said.

Medtronic and Masimo, two major pulse oximeter manufacturers, said they supported the FDA’s efforts but stood by their products. Samir Ibrahim, head of regulatory affairs for patient monitoring at Medtronic, said in an interview that the company was “very confident in the safety, quality, and clinical performance of our platform,” and its products have always met or exceeded the FDA’s expectations.

Medtronic opened a lab in Denver in 2023 to conduct research on new and existing pulse oximeters, with the intent of including diverse participants, said Roger Martin-Pressman, laboratory manager at the site. 

Medtronic also agreed to provide labels and brochures to California hospital customers about the potential for flawed readings on people with dark skin pigmentation as part of a settlement with Roots Community Health, an Oakland, California-based clinic that sued several pulse oximeter manufacturers in 2023. 

A Masimo spokesperson, in an emailed statement, said the company’s SET pulse oximetry technology has been shown to perform accurately across all skin tones, but “we recognize that there is more work to be done.”

The company is enrolling patients in real-world studies to prospectively test its devices’ accuracy in a diverse patient population, including critically ill adults with low perfusion and pediatric patients. Masimo expects to share results next year. 

What else can be done? 

Experts said other actions will be needed to ensure pulse oximeters are equitable and safe, regardless of what happens with the FDA’s guidance.

“The big picture is that this is guidance, not requirements,” Ferryman said. 

A study Ferryman co-authored in JAMA earlier this year found that the FDA’s 2013 guidance, which advised manufacturers to test pulse oximeters in a range of tones, only had a “modest effect” on testing in diverse subjects.

Some solutions could include insurance companies paying more for services that use equitable devices, or standards groups such as the Joint Commission considering pulse oximeters that underdiagnose hypoxia, or low levels of oxygen, in people with darker skin tones as an “unacceptable patient safety threat,” Ferryman said. 

Lester said that opening more labs to test pulse oximeter performance, particularly in diverse areas, could be helpful, but in a climate where funding is being cut for medical research, this could be hard to do. Currently, there are just two labs in the U.S. that do this type of testing, including one at UCSF, Lester said.

ISO, an international standards organization, is also working on a new version of its standard for pulse oximeters. The standard is currently in draft form. 

“If pulse oximeters aren't accurate in people with dark skin, it should be called out. It should be fixed,” Public Citizen’s Abrams said in an interview. “We think this is probably going to be less likely now with the current administration, but we're not going to stop trying to do it.”