A recent analysis of FDA records reveals a concerning trend in pulse oximeter testing that disproportionately affects individuals with darker skin tones. Despite voluntary FDA guidance issued in 2013 to improve diversity reporting in device testing, progress has been slow and inadequate.
The study, published in JAMA, found that only 12.5% of 767 FDA summary documents for pulse oximeters mentioned race, ethnicity, or skin tone in performance testing from 1996 to 2024. While there was an increase in reporting after the 2013 guidance—from 4.1% before to 25% after—the majority of documents still lack crucial information about testing across diverse populations.
This oversight has significant implications for patient care, particularly for individuals with darker skin. Pulse oximeters, which measure blood oxygen levels, tend to overestimate oxygen saturation in patients with darker skin tones. This discrepancy can lead to delayed or missed detection of life-threatening low oxygen levels among minority patients.
Dr. Kadija Ferryman of Johns Hopkins University, the study’s lead author, emphasized that clinicians often cannot choose which pulse oximeter to use and lack access to performance data across skin tones. This information gap hinders their ability to provide equitable care.
The issue extends beyond mere reporting. Pulse oximeter readings in darker-skinned individuals are not only biased but also more variable, compounding the risk of misdiagnosis or delayed treatment.
Experts stress that solving this problem requires a concerted effort from multiple stakeholders. While the FDA is developing new guidance, they caution that no single change will be sufficient to ensure fully equitable pulse oximeters.
As health disparities continue to be a critical concern, this study underscores the urgent need for medical device testing that accurately represents and serves all patient populations.
See: “Diversity Reporting Improved in Pulse Oximetry Testing After FDA Guidance” (December 30, 2024)
