New guidelines to encourage device manufacturers to make pulse oximeters more equitable for patients with darker skin have not been released by the Food and Drug Administration, despite agency officials saying for months new suggestions would be issued by Sept. 30.
It has been nearly four years since a group of physicians published clear evidence that pulse oximeters, the widely used fingertip devices that measure blood oxygen levels and are crucial in emergency and critical care, often missed low oxygen levels in patients with darker skin. Since then, studies have found these inaccuracies led to patients with darker skin being less likely to receive life-saving treatment during the Covid-19 pandemic and being less likely to receive supplemental oxygen they need — which can lead to death and organ failure.
The delay is frustrating many physicians who rely on the devices to gauge oxygen levels in extremely sick patients and know they are not working as well on their Black and Hispanic patients. “I should have had a better device by now,” said Theodore J. Iwashyna, a pulmonary and critical care physician and professor of medicine and public health at Johns Hopkins, who co-authored the December 2020 New England Journal of Medicine article that brought widespread attention to the issue. “How many more of my patients need to die before we fix this?”
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