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Dangerously wrong oxygen readings in dark-skinned patients spur FDA scrutiny

Finally

The meeting follows years of mounting data on inaccuracies and potential harms.

A nurse uses a pulse oximeter on a patient in Plainfield, New Jersey, on October 26, 2016.

Enlarge / A nurse runs on the pulse oximeter on an individual in Plainfield, NJ, on October 26, 2016.

For a long time, studies have discovered racial bias in keeping oxygen measuring devices called pulse oximeters, in addition to alarming dangers from inaccurate blood oxygen measurements in dark-skinned patients. Now, the united states Food and Drug Administration is summoning its expert advisors to examine the problematic devices and consider new recommendations and regulatory actions.

The FDA announced Thursday that its advisory committeethe Anesthesiology and Respiratory Therapy Devices Panel (ARTDP)would convene on November 1 to go over pulse oximeters. Until then, the agency renewed focus on the safety warning it issued in February 2021, which noted that the ubiquitous devices “could be less accurate in people who have dark skin pigmentation.”

That warning closely followed a report from December 2020 that highlighted the racial bias of pulse oximeters amid the COVID-19 pandemic. The global spread of a respiratory disease with a hallmark symptom of breathing difficulty sent pulse oximeter usage soaringelevating the issue of racial disparities. The 2020 studyled by researchers in Michigan and published in the brand new England Journal of Medicinefound that pulse oximeters were nearly 3 x more prone to miss dangerously low blood oxygen levels (hypoxemia) in Black patients weighed against white patients.

From there, other studies corroborated the racial bias and highlighted the chance it posed to dark-skinned patients through the pandemic and beyond. But, it really wasn’t the initial study to report the concerning bias. Researchers have long noted the racial disparity, with studies dating as soon as 1991.

Dubious devices

Pulse oximeters were developed in the 1970 and also have since turn into a mainstay in routine patient care, with current devices typically clipping onto a finger. They estimate blood oxygen saturation (SpO2) by assessing the relative absorbance of two wavelengths of light (red and infrared, generally) beamed in to the finger, in addition to the pulse-based blood circulation through the arteries.

But, the devices were mainly tested and calibrated on light-skinned patients. Researchers suspect that the high degrees of skin pigment, melanin, in dark-skinned patients can hinder the absorbance measurements. Numerous studies have discovered that pulse oximeters have a tendency to overestimate oxygen saturation in dark-skinned patients.

The dangers of these faulty readings were realized through the pandemic. A report published in-may discovered that pulse oximeter’s overestimation of SpO2 in Black and Hispanic patients with COVID-19 caused significant delays in care, including usage of lifesaving treatments, such as for example dexamethasone. For a few patients, the faulty readings meant their eligibility for treatment was never identified by the devices. That study, led by researchers at Johns Hopkins University, appeared in JAMA Internal Medicine.

In July, another study in JAMA Internal Medicine by researchers in Boston, found darker skinned patients in intensive care who had inaccurate pulse oximeter readings finished up receiving less supplemental oxygen. Meanwhile, a report published in exactly the same month in BMJ by researchers in Michigan viewed records greater than 30,000 patients at the Veterans Health Administration between 2013 and 2019. It discovered that Black patients were more prone to have hypoxemia undetected by pulse oximetry. The analysis notes that hidden hypoxemia is associated with an increased threat of morbidity and mortality.

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