December 1, 2023
FDA to Give Pulse Oximeters an Equity Revamp
Throughout the COVID-19 public health emergency, the pulse oximeter example was one of the most cited health equity challenges. Although pulse oximeters can be a game-changing tool in assessing the severity of disease, especially at home, they do not work for all people reliably. For those with darker skin tones, pulse oximetry readings can vary widely, deepening disparities in disease severity and mortality. The FDA’s Center for Device and Radiological Health (CDRH) is taking on the challenge, with work sessions and discussion papers to engage the scientific community. Comments on the discussion paper are due by January 16, 2024; public hearings will begin in February. This is all part of larger discussions among policymakers on how to ensure that medical devices, clinical algorithms, and medical technology don’t exacerbate health disparities or introduce racial bias.
Pulse oximeters are so critical that the American Medical Association calls making sure they work equitably an “obligation we all share” in health care. Decades of research show that many pulse oximeters do not meet the FDA’s safety standards for darker-skinned people. They work by detecting oxygen in the blood through optical color sensing, but the calibration and resulting readings are often inaccurate for people of color. During the pandemic, however, pulse oximeters were the best tool many communities had to detect oxygen levels and make triage decisions.
The medical community has the chance to partner with the FDA to help solve the problem.
Doctors and lawmakers have been calling on the FDA to address racial disparities in pulse oximeter results for nearly three years. Now, the FDA is hosting new working groups and requesting feedback on concerns related to equity in pulse oximetry.
- The Agency is requesting feedback on its discussion paper, Approach for Improving the Performance Evaluation of Pulse Oximeter Devices Taking Into Consideration Skin Pigmentation, Race and Ethnicity, through January 16th.
- Those looking to inform this next challenge for health equity can participate in the CDRH’s virtual public meeting of their medical devices working group on February 2, 2024.
The FDA has also launched multiple real-world pulse oximeter performance studies in both adults and children, kickstarted analyses into how factors like skin pigmentation affect device accuracy and shifted its research focus to closely evaluate product efficacy on darker skin. To catch up on some of the work being done so far, see the FDA’s meeting summaries and public communications.