- Attorneys general from 25 states have asked the Food and Drug Administration to “act with urgency” to address pulse oximeters’ race and color bias, one year after the agency held a public meeting in response to accuracy and safety concerns.
- In a letter to FDA Commissioner Robert Califf, the attorneys general outline evidence that the accuracy of pulse oximeters is affected by skin tone and call on the regulator to immediately take six actions to ensure the safety and effectiveness of the devices.
- The attorneys general want the FDA to “require manufacturers and vendors of pulse oximeters to include clear, comprehensible and evidence-based warning labels” and write to healthcare providers about “the risks and reduced efficacy” of the devices for people with darker skin tones.
COVID-19 raised the profile of long-standing worries about the accuracy of pulse oximetry, a noninvasive method for monitoring a person's blood oxygen saturation, and generated new evidence to support the worries.
A paper published in 1987 looked at the effect of skin pigmentation on the accuracy of pulse oximeters. Papers on the use of pulse oximeters in the emergency department, for critically ill patients and in other settings followed over the next roughly 20 years, generating conflicting answers to the question of whether skin tone affects accuracy.
The pace of research increased after people started using the device to assess the effect of COVID-19 on their lungs. The FDA began reviewing the evidence in 2021. The next year, researchers published papers showing that inaccurate pulse oximeter readings led to disparities in supplemental oxygen and delayed the treatment of Black patients with COVID-19 by hours.
One year ago, the FDA told an advisory committee convened to discuss the topic that “there is mounting evidence from real-world studies that suggest performance of pulse oximeters can be affected by skin pigmentation.”
The attorneys general wrote to the FDA last week because “pulse oximeters continue to be sold without clear warning labels or other guidance to protect individuals from harm.” One year on from the meeting, the legal advisers want the FDA to act immediately to mitigate the risk of the link between skin tone and pulse oximeter accuracy that it identified in its briefing to the advisory committee.
As well as requesting updated labels and a letter to healthcare providers, the attorneys general asked the FDA to revise its November 2022 safety communication, accelerate the review of the advisory committee’s recommendations and “update and finalize regulations requiring demographically representative clinical trials for previously approved medical devices like pulse oximeters.”
The attorneys general also asked the FDA to add warnings to other diagnostic tools and medical technology that incorporate pulse oximeter readings, reflecting concerns that “software or other tools that make predictions of future healthcare needs based on past pulse oximetry data with embedded color bias could end up reproducing health disparities based on race.”