Pulse oximeters, whose use increased during the pandemic, could lead to inaccurate results, the US Food and Drug Administration warned Friday. Earlier this week, the US Centers for Disease Control and Prevention updated the clinical guidance for coronavirus, and data from several studies showed that skin pigmentation could affect device accuracy, doctors and nurses. Warned.
“Pulse oximeters may help estimate blood oxygen levels, but these devices have limitations that can lead to inaccurate measurements,” said FDA’s Devices and Radiation Health Center products. Dr. William Maisel, director of the Department of Evaluation and Quality, said. In the statement.
A pulse oximeter is a small clamp-like device that is painlessly attached to a patient’s finger and constantly monitors the amount of oxygen in the blood. Hypoxia levels indicate that the patient may be exacerbated because Covid-19 is a respiratory illness that first attacks the lungs. CDC data show that blacks, Latin Americans, and Native Americans are four times more likely to be hospitalized with Covid-19 than others. A recent warning comes after a study published in the New England Journal of Medicine in December. Dr. Michael Sjoding of the University of Michigan and several colleagues analyzed data from more than 10,000 patients. For each patient, the oxygen levels recorded by the pulse oximeter were compared to the oxygen levels measured by arterial blood gas. This is a much more accurate, but painful and invasive procedure.
Researchers wanted to know how often pulse oximeters show relatively normal oxygen levels, even though they should have recorded more concerns.
In Caucasian patients, the pulse oximeter showed a 3.6% chance of misleading numbers. In black patients, that was 11.7% of the time.
The takeaway is that the pulse oximeter was three times more likely to miss significantly lower oxygen levels (or hypoxemia) in black patients. This study suggests that 1 in 10 black patients may have deceptive results.
Why the readings are not accurate
There is a relatively brief explanation for why. The pulse oximeter works by sending two types of red light from your finger. A sensor on the other side of the device senses this light and uses it to detect the color of the blood. Bright red blood is highly oxygenated, but less blue or purplish blood. If the device is not tuned for darker skin, pigmentation can affect how light is absorbed. Dark nail polish can cause similar effects.
Experienced physicians do not rely solely on pulse oximeters to make diagnoses or determine how to treat patients, said the director of emergency medicine and respiratory medicine at the Montefiore Medical Center in New York. Says Dr. Michel Nggon.
“They never tell patients that they don’t care how sick you are. Don’t worry unless the number is okay,” says Dr. Gong. “It’s a tool, and as a tool, we need to be able to use it properly in the context of other information.”
However, Dr. Gong said the pulse oximeter numbers are more important when the hospital is overwhelmed during the pandemic and doctors who may not normally be in the emergency room are brought in to see and triage the patient. It states that it may become. Inaccurate readings can be especially problematic if the patient’s oxygen levels are borderline.
Doctors also need to be aware of their own unconscious prejudices, Dr. Gong says. Studies show that, for example, when African Americans complain of pain, whites are less likely to receive more (or any) painkillers. If a patient says they have breathing problems, the doctor should not dismiss them just because the pulse oximeter readings are normal.
“The only way we can reduce health inequalities is if we attack it for multiple purposes, both from greater contributions and from our personal interactions,” says Dr. Gong.
Doctors are not the only ones using pulse oximeters. When the hospital reached capacity during the pandemic, some less severe Covid-19 patients returned home to monitor their progress. According to market research, home pulse oximeter sales have increased by 500% since the arrival of the new coronavirus in the United States.
Amy Moran-Thomas, a professor of anthropology at MIT, began researching pulse oximeters last year when her husband returned home with a pulse oximeter.
Survey results are not new
Moran-Thomas revealed a study dating back to the 1990s, suggesting problems with pulse oximeters in dark-skinned patients.
In 2005, a study conducted at the Hypoxia Lab at the University of California, San Francisco, found that three different models of pulse oximeters overestimated oxygen levels in dark-skinned patients. They followed up in 2007 with similar results.
“Reading 77 like my husband can hide the low true saturation of 69. The imminent danger is even greater, but paramedics and nurses detect these discrepancies. It may not be possible. The numbers appear to be objective and race-neutral, “Thomas wrote in a Boston review.
Moran-Thomas wondered why the problem identified decades ago hasn’t been fixed yet.
“I’m a lung and life-saving physician,” says Dr. Sjoding, who began his research after reading the Moran-Thomas article. “One of our co-authors is a prominent black doctor at the University of Michigan. None of us knew this. None of us knew about these studies since the mid-2000s. It wasn’t part of our training. “
It seems that public attention is increasing. On January 25, several US senators sent a letter to the FDA urging them to investigate the issue. The FDA is responsible for approving medical pulse oximeters before they are put on the market. Authorities are now demanding that pulse oximeters be tested on a variety of skin tones. That is, “at least two dark pigments (subjects) or 15% of the subject pool, whichever is greater.” The FDA states that it is carefully reviewing the available data. To determine if additional guidance or research from the agency is needed. We recently approved a smartphone pulse oximeter that claims to work on all skin tones. It uses an automatic calibration period of 10 to 20 seconds to accurately measure how light is moving through the user’s skin.
“These devices are not intended to be the sole or primary use of information to make clinical diagnosis or treatment decisions,” Dr. Maisel told CNN in an interview Wednesday. “Someone should not be overly dependent on pulse oximeter readings, even if it is the most accurate product.”
“When you make a decision, make sure you are aware of it,” says Dr. Sjoding. “Pulse oximeter readings may be off by a few points. If so, would you care for this patient differently?”
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