Amid a growing wave of evidence demonstrating how pulse oximeters regularly deliver inaccurate readings for people with darker skin tones, the FDA is stepping in.
The agency has set a date for a virtual meeting of its medical devices advisory committee to discuss the devices’ racial bias. It’ll take place Nov. 1 and will feature the committee’s anesthesiology and respiratory therapy devices panel of outside experts.
Members of the panel will talk over the many studies depicting pulse oximeters’ inaccuracies and the factors that may lead to those incorrect readings. That, in turn, will help them devise potential recommendations for patients’ and healthcare providers’ ongoing use of the devices and determine the exact amounts and types of data that should be submitted to the FDA for the authorization and regulation of pulse oximeters moving forward.
The meeting will be open to the public, and the FDA is accepting public comments on the matter through Dec. 1. Any comments received before Oct. 18 will be provided to the committee, while those submitted after that date will still be taken into consideration by the FDA.
Pulse oximeters are typically placed over the fingertip, where they emit light beams through the skin to estimate a wearer’s pulse rate and the level of oxygen saturation in their blood.
Because many of the devices—like so many other medtech and pharmaceutical products—were developed and tested on a predominantly white study pool, they’ve been shown to work less effectively on users with darker skin tones, regularly overestimating oxygen saturation levels that may have actually dipped below healthy ranges.
Study results published in The New England Journal of Medicine in late 2020 found that Black patients were nearly three times more likely than their white counterparts to have hidden hypoxemia—in which arterial oxygen saturation falls below 88%, despite pulse oximeter readings of at least 92%—that went undetected by pulse oximetry.
The study’s authors noted at the time that “reliance on pulse oximetry to triage patients and adjust supplemental oxygen levels may place Black patients at increased risk for hypoxemia,” a risk that’s been further worsened by the COVID-19 pandemic, in which pulse oximetry has been crucial for making treatment decisions.
Indeed, another study published in May of this year looked specifically at the use of pulse oximetry in COVID treatment and found a “statistically significant delay” in delivering crucial therapies like supplemental oxygen to Black and Hispanic patients.
Amid these findings, a handful of new medtech developers have stepped up to build pulse oximetry devices that work just as effectively on patients of all races and skin tones. For its part, the FDA has issued guidelines around using the devices that warn against relying solely on pulse oximeters to assess oxygen levels and overall health conditions.
The agency has also recommended since 2013 that at least two participants or 15% of the entire pool—whichever is larger—in every clinical study of prescription-use oximeters have more heavily pigmented skin, though that’s still only a recommendation, not a requirement for authorization of the devices.