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Years of research have shown the same. Pulse oximeters provide less accurate readings for people with darker skin tones, and now the US Food and Drug Administration is proposing guidance. To help make these tools more reliable and less biased.
Pulse oximeters are small finger wear devices that measure how much oxygen is being carried in the blood. Available both over the counter and by prescription, they have grown in popularity during the Covid-19 pandemic. However, several studies have shown that pulse oximeters can measure blood oxygen levels higher than those for people with dark skin.
The FDA announced the publication on Monday Draft guidance For manufacturers of pulse oximeters who provide recommendations for clinical testing and labeling of these electronic medical devices.
One Recommendations Clinical studies of the devices are to include “150 or more healthy participants of different skin colors,” with at least 25% of participants falling within a known system within each skin color group. Monk Skin Tone Scale.
Another is for manufacturers to “effectively display appropriate warnings” in the device's instructions, such as “informing patients that differences in skin color may cause differences in pulse oximeter sensor performance.”
“This draft guidance is consistent with FDA's broad commitment to promoting high-quality, safe, and effective medical devices,” said Dr. Michelle Tarver, director of the FDA's Center for Devices and Radiological Health. Agency announcement. “Our draft recommendations are based on the best available science to help address the concerns of inaccurate performance of pulse oximeters based on an individual's skin color.”
The FDA is requesting public comment on the draft guidance within 60 days, and the agency will review and consider the comments before finalizing the guidance.
Pulse oximeters are attached to the fingertip and send a beam of light through the finger to estimate heart rate and blood oxygen levels. A sensor on the other side of the device receives those light rays and uses them to detect the color of a person's blood. Bright red blood is more oxygenated, blue or purple blood is less.
If these devices are not adjusted for darker skin tones, the skin tone can affect how that light is absorbed by the sensor, leading to inaccurate oxygen readings.
There were pulse oximeters It was created in 1974and evidence of inaccurate pulse oximeter readings in dark-skinned individuals In the 1980s.
A study, Published in 2022Among more than 3,000 hospitalized patients under intensive care, Asians, blacks and Hispanics received less supplemental oxygen than white patients, which was linked to differences in their pulse oximeter readings.
Another paper has been published In 2022 Black patients are more likely than white patients to have low blood oxygen as measured by their pulse oximetry readings, but not detected by pulse oximetry—so they have a higher chance of error.
So did a separate study of nearly 7,000 Covid-19 patients Published in 2022Compared with white patients, blood oxygen levels measured by pulse oximetry were estimated to be 1.7% lower in Asian patients, 1.2% in black patients, and 1.1% in Hispanic patients. That overestimation has contributed to a patient not receiving certain Covid-19 treatments when they seek care.
FDA He held two advisory panel meetings – in 2022 And In the year 2024 – To discuss ways to improve and evaluate the accuracy and performance of pulse oximeters, and the agency a Security communication Be warned that the tools have limitations and may be less accurate in people with darker skin tones.
The FDA's new draft guidance applies to pulse oximeters intended for medical use, primarily for use in hospital settings and doctors' offices, and not for devices sold as general safety products, which are often sold directly to consumers over the counter.
Some pulse oximeters on the market may meet revised recommendations according to the FDA, but if so, that should be indicated on their label.
The agency proposed in the new draft guidance to create a public website identifying all pulse oximeters that have been FDA-cleared and FDA-reviewed.
The recommendations are not binding, and a new federal administration is taking office shortly, said Carmel Shachar, faculty director of the Health Law and Policy Clinic. Harvard Law SchoolNot involved in the draft directive.
“It's a challenging time to get this out now and get the people to support it and find out what the priorities of this new administration are. So there's a risk there,” Shachar said.
There are also concerns that manufacturers may not fully comply with the FDA's guidelines, said Dr. Theodore J. Johns Hopkins University.
In 2013 The FDA has issued a premarket guidance. It recommends that manufacturers of pulse oximeters be represented in clinical trials of the devices, including at least two “blacks or 15% of the study group, whichever is larger.” But a A research paper published last week In the journal JAMA, that opinion was downplayed.
“Given how little compliance there was when the last voluntary guidelines were issued a decade ago, we can only hope that the FDA completes and enforces these,” Iwashina, who was not involved in the FDA's revisions, said in an email Monday. “Without formalization, enforcement and compliance, I'm not sure why we should expect these 'proposed new draft recommendations' to result in better products and therefore better and fairer care.”
Some public health experts also worry that many over-the-counter pulse oximeters are not included in the recommendations. But in general, Shachar said she wants to fully implement the new draft directive.
“I really like his frame, because he's trying to provide a lot of carrots for manufacturers to do the right thing, to participate in the research to make sure there's no bias in their devices,” Shachar said.
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“If you do that and you do that with a meaningful number of studies — 150 — then this guideline says you can get a label that says your device works similarly across patient groups and can go into a registry or some kind of public face list that the FDA is going to compile,” she said. “Maybe he's trying to walk a fine line. Not trying to remember biased tools, that's for sure. 'We encourage them to come to market to label these good products in a way that encourages consumers to use them'. ”
Iwashyna added that the new guidance should provide more detail on how the FDA has developed criteria for what it considers inadequate performance in patients with darker skin in terms of performance and safety.
“The current document proposes a 'fair' overall tolerance, based on what current devices can do, rather than being safe for dark-skinned patients,” he said. “I think our patients deserve guaranteed safety, not manufactured safety restrictions.”