The attorneys general from 25 states, including New Jersey, have asked the U.S. Food and Drug Administration (FDA) to “act with urgency” to address the accuracy of pulse oximeters because of evidence of reduced efficacy of these medical devices on patients with darker skin tones.
The letter to FDA Commissioner Robert Califf, M.D., the attorneys general urge the government to “require manufacturers and vendors of pulse oximeters to include clear, comprehensible and evidence-based warning labels.” The attorneys general also want healthcare providers to be notified by letter about “the risks and reduced efficacy” of these devices for people of color.
In their Nov. 1 letter, the attorneys general noted that it had been one year since the FDA held a public hearing on the safety concerns related to pulse oximeters, which are fingertip devices that measure blood oxygen levels – a crucial diagnostic indicator. However, the FDA has taken no action to date, effectively allowing pulse oximeters to continue being sold and used in homes and medical facilities without warning levels or other guidance to protect individuals from harm, the letter stated.
The letter cites numerous studies finding disparities in care for darker skin patients because of inaccurate readings of pulse oximeter devices. Oxygen readings for people with darker skin tones, or those wearing nail polish, can register higher than they really are, which leads to patients not being administered the supplemental oxygen they really need. This can have critical consequences especially for newborn infants or people with respiratory illnesses.
“It is imperative that the FDA act now to prevent additional severe illness and mortalities among darker skinned people resulting from inaccurate or misleading pulse oximeter readings as well as inadequate diagnostic and treatment protocols and procedures,” the letter stated.
“It is unconscionable in a multi-racial, multi-ethnic nation with populations spanning the color, age, and medical vulnerability spectra that sub-optimal and potentially harmful diagnostic technology such as the pulse oximeter is not calibrated to adjust for skin color,” the letter said. “Ultimately, patients of color need and deserve technology that works as well for them, as it does for the predominantly white patient population with whom this tool was originally designed and tested.”