Dubai, United Arab Emirates (CNN) — Amidst the health threats we are witnessing due to respiratory diseases, namely influenza, Covid-19 and respiratory syncytial virus, emergency departments use a small tool to monitor whether a patient needs oxygen.
“We’re in the midst of a respiratory disease flood,” said pediatric emergency physician Dr. Joseph Wright, chief health equity officer at the University of Maryland Medical System, which includes 11 hospitals.
He added, “Pulse oximetry is used for all patients.. At the moment, it is a tool that is used to assess the condition of children who suffer from respiratory distress, as part of the respiratory syncytial virus outbreak that we are currently witnessing.”
However, a growing body of research suggests that these devices, which are worn on a patient’s fingertips to measure blood oxygen levels, may not work as well for people with darker skin.
The US Food and Drug Administration is considering next steps to regulate pulse oximeters, which may give less accurate readings for people of color.
Its Medical Device Advisory Committee met in November to review clinical data on the issue.
The Food and Drug Administration is considering how to proceed
Pulse oximetry works by sending light through your finger. A sensor on the other side of the device receives this light and uses it to detect the color of your blood.
He states that bright red blood is highly oxidized, but blue or purple blood is less so.
And if the device is not calibrated for darker skin tones, melanin, which is responsible for the pigmentation of skin, hair and eyes, can affect how light is absorbed by the sensor, leading to false oxygen readings.
“The agency is making this a high priority,” FDA spokeswoman Shawna Nelson wrote in an email to CNN. “We will look at the committee’s notes, determine appropriate next steps … and will communicate any significant new information publicly.”
“Concerns about the accuracy of pulse oximetry in pigmented skin have been noted for more than 30 years,” American Medical Association President-elect Dr. Jesse Ehrenfeld said in a statement. “However, dark-skinned communities continue to experience adverse health effects from these devices, particularly During the COVID-19 pandemic when pulse oximetry is used and relied upon so much.”
Pulse oximetry was invented in 1974.
And a body of research dating back to the 1980s suggests that among patients with darker skin, defective pulse oximetry readings can be a real, life-threatening problem.
In contrast, the makers of some pulse oximeters have reported that their studies show no evidence of racial bias in the accuracy of their devices.
Studies using Medtronic’s Nellcor pulse oximetry found that it reported blood oxygen levels that were within 2% of participants’ blood oxygen levels, regardless of skin color.
“However, the data shows a small statistical discrepancy between the results for lighter-skinned and darker-skinned people,” Dr. Sam Agezian, Medtronic’s chief medical officer for patient monitoring, said in an emailed statement to CNN.
“Medtronic is seeking improvements in our devices based on our understanding of the effect of skin pigmentation on pulse oximetry readings,” he added.
“By better sharing of information, we call for improving the methods we use to validate pulse oximeters, including standardizing how we assess skin pigmentation and increasing the representation of dark-skinned patients in clinical trials.”
Medical technology company Masimo was of the same opinion.
“We also calibrated and validated our oximeters using approximately equal numbers of dark-skinned and light-skinned individuals,” Dr. William Wilson, Masimo’s chief medical officer, told the FDA’s advisory committee. “We support future clinical studies.” And patient studies on this topic, and we’re currently pursuing those studies.”