OAKLAND, CA – The patient is a 60-year-old African-American man suffering from emphysema. An oximeter attached to his fingertip showed blood oxygen levels well above 88%, indicating the risk of organ failure and death.
However, the doctor, Noha Aboelata, believes that the patient is sicker than the machine shows. So he sent him for lab tests, which confirmed his suspicions about the need for supplemental oxygen at home.
A few months later, in December 2020, Aboelata thought of his patients when he read an article in the New England Journal of Medicine showing that pulse oximeters three times more likely to avoid very low blood oxygen levels in black patients, as in whites. At a time when America’s Covid-19 death rate is sky high and hospitals are struggling to get beds and oxygen to those who need it, the findings reveal one of the most striking examples of racism institutional in American health care.
“I thought, ‘Is there another patient I’m missing?’ said Aboerata, a family physician and CEO of Roots Health Community in Oakland. When he shared the article with colleagues, “There was a lot of anger and frustration because we had every reason to believe that we could rely on these tools and they would not working regularly in the populations we serve.
Attorney General of the State And grandfather of AS The FDA has been forced to take action to eliminate racial bias in pulse oximetry that leads to treatment delays and worse health outcomes, and has recently raised concerns about this. Reliability of hospital AI tools which receives a lot of information from the device.
The Aboelata Clinic has sued manufacturers and stores that sell oximeters, asking them to recall the devices or add safety warnings to their labels. Many of his patients rely on home oxygen, which requires accurate readings for Medicare coverage.
But it is not an option to abandon devices that are central to the treatment of heart and lung disease, sleep apnea and other conditions.
Since the 1990s, easy-to-use finger tubes have been used for many purposes to read arterial blood gases, which are the gold standard for determining oxygen levels, but are dangerous if not done carefully. Oximeter manufacturer for sale about 3 billion dollars of them this year because they are used in almost all hospitals, clinics and long-term care facilities. During the pandemic, hundreds of thousands of Americans bought them for home use.
One of them is Walter Wilson, a 70-year-old San Jose businessman who has received two kidney transplants since 2000. Wilson was diagnosed with Covid-19 last December, but postponed a doctor’s visit because his home pulse oximetry reading within normal. range.
“I’m black. I am very sick. “If the oximeter had detected it, I would have gotten to the hospital earlier,” he said.
Wilson returned to dialysis after several years in good health. Now he wants to join a class action lawsuit against the device maker.
“They’ve known for years that people with darker skin get bad readings,” he said, “but they haven’t tested it in healthy people.” “
After several years of not taking much action on this problem, the FDA put in 2021 add security alerts Talk to your doctor about an oximeter. They also funded research to improve the device and promised to provide new directions for its creation.
But as the FDA updates draft guidelines it hopes to publish on October 1, doctors and scientists don’t know what to expect. The group noted that the manufacturer suggested testing the new oximeter on a larger number of people, including a higher percentage of dark-skinned people.
Michael Lipnick, an anesthesiologist and researcher at the University of California-San Francisco, said that due to industry opposition, the guidelines do not require device manufacturers to test oximeters in real-world conditions.
People in hospital often experience dehydration and restricted blood flow to their organs. This condition, called low perfusion – literally poor circulation – is very common in cardiovascular diseases, which are more common in black patients.
Pigmentation and poor perfusion “work together to reduce pulse oximetry,” said Philip Bickler, who directs the Hypoxia research laboratory at UCSF. “During the Covid-19 pandemic, black patients have become sicker due to the many barriers patients face in accessing health services. They appear near death and have lower blood pressure.”
FDA guidelines are expected to require manufacturers to measure their devices in patients with poor perfusion. All of this means that the FDA’s efforts could produce a device that works in healthy black adults but “doesn’t solve the problem,” said Hugh Cassier, who chairs the FDA’s Medical Devices Advisory Committee. FDA at their February meeting.
History of inactivity
Although some recent industry-sponsored studies show that certain devices work on skin tones, studies conducted in the 1980s found inconsistencies in pulse oximetry. In 2005, Bickler and other scientists at the Hypoxia Laboratory published evidence that three main devices did not consistently detect hypoxemia in dark-skinned patients – especially those with severe oxygen deprivation. Because these readings are critical to guiding treatment, the authors recommend that oximeters be used as a precaution.
The FDA’s response was simple. Its regulatory path for pulse oximeters allows them to be sold as long as they show “substantial equivalence” to devices already on the market. In a 2007 draft guidance document, the FDA suggested that the new oximeter test “may cover a limited number of subjects with dark skin pigmentation, such as 30%.” However, the latest guidelines, published in 2013, recommend “at least 2 Black Dark themes or 15% of your theme set, whichever is greater.” Studies should only be 10 subjects. And the group does not define “black pig.”
The device test involves wearing a mask on a patient that monitors respiratory gases while simultaneously taking pulse oximetry readings and arterial blood samples fed into a high-pressure measuring device. precision created by the late Hypoxia Lab founder John Severinghaus.
“You can’t always trust what the manufacturers say,” said Bickler, who tested an experienced mechanic’s skepticism when looking at the number of machines in his lab. .
Their data, he said, ranged from “completely inaccurate” to “obtained in completely idealized conditions, unlike real-world performance.”
During the pandemic, a medical charity came to the laboratory to donate thousands of oximeters to poor countries. The oximeter he chose was “not very good,” he said. After that, the lab started working Your status pagetype of Consumer Reports for pulse oximeters.
According to his tests, some expensive devices do not work; few $35 devices are more efficient than their $350 competitors. According to the site, more than a third of the tested devices on the market do not meet current FDA standards.
To test whether an oximeter test was feasible in the real world, the FDA funded a UCSF study involving nearly 200 intensive care patients. Bickler said data from the study is being prepared for peer review for publication.
He said the lab did not warm patients’ hands in the study, which is common practice for manufacturers when testing devices. Heating ensures better circulation in the fingers attached to the device.
“This affects the signal-to-noise ratio,” said Bickler. “Remember when car radios had AM stations and you got a lot of static? That is what causes poor perfusion – creating noise or static electricity that obscures the clear signal from the device. “
Hypoxia laboratory scientists – and doctors in the real world – do not warm patients’ hands. But “people in the industry can’t agree on how to solve it,” he said.
Masimo, a company that says so most accurate pulse oximeter Daniel Cantillon, Masimo’s chief medical officer, said in an interview that the market was happy to follow the FDA guidelines.
How many ways to solve the problem?
The best equipment, according to the Hypoxia laboratory, It costs $6,000 or more. This points to another problem.
With better accuracy, “you reduce patient access to devices for the majority of people in the world who can’t afford it,” Lipnick said.
Even if the FDA doesn’t like everyone, its proposed call for more people of color to undergo oximetry tests “ensures true diversity in the development and testing of the those devices before they come to market,” Lipnick said. “Standards have been very low for decades.”
It is difficult to estimate the potential harm to an individual from inaccurate oximeter readings because these errors are often the cause of a chain of events. But studying at Johns Hopkins University and elsewhere showed that patients with undiagnosed oxygen deprivation—perhaps thousands of patients—delayed treatment and had worse outcomes.
Aboelata said some manufacturers – Zewa Medical Technology, Veridian Healthcare and Gurin Products – have responded to the Community Roots health lawsuit by including warnings about the limitations of their devices.
He said there’s not much he and other doctors can do in daily practice, other than set a baseline number for each new patient and look for significant reductions. He said hospitals have other devices to check oxygen levels, but accurate readings are important for outpatient care. In 2022, Connecticut passed a law prohibiting insurance companies from denying home oxygen or other services based solely on pulse oximeter readings.
But “switching to destructive devices is not the answer,” said Theodore Ivashina, a professor at the Johns Hopkins Bloomberg School of Public Health who co-authored the New England Journal of Medicine article. “Less equipment is the solution.”
KFF Health News is a national news center that does in-depth journalism on health issues and is one of the main operating programs KFF – an independent source for health policy research, polling and journalism.
2024-10-18 19:44:00
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