Device makers’ work to improve the performance of pulse oximeters in people with dark skin tones has made little progress since the Food and Drug Administration asked manufacturers in 2013 to voluntarily test the devices on a wider range of skin tones, a study shows. which was published Monday in JAMA. The research and a related editorial suggest that clearer guidelines, enforcement and possibly legal action may be needed to ensure the devices work well on all skin tones.
The new research analyzed paperwork submitted for FDA approval to market a 767 oximeter device approved between 1978 and 2024 that contained accessible information about performance testing. The authors found references to skin color, pigmentation, or race in 4% of documents submitted before the FDA’s 2013 suggestion to diversify skin color testing. That number rose to just 25% of submissions after the guideline was released – a number the authors say is still far too low and shows how little has been done to solve a problem – poorer performance in patients with a dark skin color – which has been known for decades.
“It’s completely mind-boggling to me that we had these reports in 1987, in 1990, in 2005, in 2007, in 2020, and that we as a health care system have failed to resolve this,” said Theodore J. Iwashyna, a from the study authors and a practicing critical care physician and professor at Johns Hopkins University. “Our patients need better devices now.”
Although there was an increase in the use of terms related to skin color, race and ethnicity, researchers found repeated inconsistencies and a lot of confusion in how the terms were defined and used.
“Sometimes these were combined in interesting ways,” said Kadija Ferryman, assistant professor in the Department of Health Policy and Management at the Johns Hopkins Bloomberg School of Public Health and lead author of the paper. “One of the summaries we examined mentioned that people were participating in performance tests with ‘light skin tones of Chinese descent.’ There’s a lot to unpack there: What does “Chinese origin” mean? How is it defined?”
Ferryman called the lack of better addressing the problem by manufacturers seeking approval for their devices “frustrating, but not surprising,” given the relative lack of attention to health issues facing marginalized groups.
It has been known for decades that pulse oximeters, the fingertip devices used to non-invasively measure oxygen levels, overestimate oxygen levels in patients with darker skin. melanin in the skin can interfere with the signals the devices read. Interest in the issue increased during the Covid-19 pandemic, when the devices were often used to triage patients for emergency care or admission to intensive care, and afterwards a high-profile 2020 study in the New England Journal of Medicine Research found that black patients were almost three times more likely than white patients to have low oxygen levels go unnoticed. Subsequent investigations have shown that the devices led to this delays in Covid treatment and supplemental oxygen use, and higher mortality rates for patients with dark skin.
Spurred by these reports, FDA officials did just that issued a warning on the devices, held advisory board meetings, wrote a discussion paper on the issue and said they would take action to release new guidelines for manufacturers to help create more equitable devices. FDA spokesperson Carly Pflaum said the agency is actively working to release the draft guidance “as quickly as possible.”
Delays in issuing those guidelines — promised last year but now expected in fiscal 2025 according to the FDA — have angered health care leaders who say inaction on this issue endangers the lives of Black people, and physicians who rely on the devices to assess oxygen levels for clinical decision making.
Iwashyna, who is working in intensive care this holiday, said he is forced to decide whether black patients need painful arterial punctures to determine their true oxygen levels. “We have to make tougher choices for our black patients than we do for our white patients because the pulse oximeters are just not as reliable in our black patients,” he said.
Some manufacturers have done so, citing their own internal investigations argued that their devices do work good on a range of skin tones. More research is being done to create more equitable devices and provide better guidance on testing them.
A related editorial in Monday’s issue of JAMA, which includes some of the same authors on the study, said that repairing pulse oximeters is an example of a “wicked problem” — a problem with no easy solution that involves several decision makers whose values conflict with each other. The editorial said stronger and clearer guidance from the FDA is needed but may not be enough to usher in change. Challenges, they said, include the costs to manufacturers of coming up with fairer devices and testing them on larger groups with more diverse topics, and the fact that many manufacturers are reluctant to admit that their devices may be biased.
Several device makers, including Medtronic, have settled a lawsuit filed by CEO Noha Aboelata of Roots Community Health, a community health center in Oakland, California, and have agreed to warn consumers and medical professionals about their devices. Senators and attorneys general of several states have also called for change.
That change could be encouraged, the editorial said, if federal purchasing power provided pre-purchase agreements for more equitable devices now in development, or higher reimbursements for devices proven to be more equitable.
“Let’s say a less biased device comes to market, but is a lot more expensive,” said Carmel Shachar, an assistant clinical professor of law at Harvard Law School and first author in Monday’s editorial. “Without economic incentives, it may be difficult to quickly adopt the newer devices.”
Shachar said she also worried that new FDA guidelines would do little to fix devices already in use. “Some concerns I have are whether this will only apply to new devices in the future, and whether the older devices can still remain on the market, which is likely to be the case,” she said.
Another route to possible change is now discussed is a result of Section 1557 of the Affordable Care Act, which prohibits discrimination in health care and gives patients who believe they have been harmed by medical providers using known defective devices the right to sue. One study found that in the VA system alone, the devices were responsible 80,000 missed measurements of hypoxemiaor low oxygen in a given year, figures that may not change until better devices come into use.
“More is needed to help develop and bring newer devices to market that don’t have the same problems,” Shachar said. “Once we have alternatives, more thought needs to be given to whether we can retire the older devices.”
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