The Food and Drug Administration (FDA) has released draft guidance aimed at improving the accuracy of pulse oximeters across all skin tones. This move follows concerns that these devices, crucial for measuring blood oxygen levels, may be less accurate in individuals with darker skin pigmentation.
The draft guidance outlines recommendations for premarket submissions of medical pulse oximeters. It emphasizes the need for validation of device accuracy and ensuring testing encompasses a wide range of skin pigmentations. The FDA also suggests that devices include a prominent statement on their label if they have demonstrated comparable performance across diverse skin pigmentations.
Key Recommendations
The new guidelines propose several key changes to how companies test their pulse oximeters:
- Increased Enrollment: Clinical studies should include at least 150 patients with diverse skin tones.
- Representation of Darker Skin Tones: Each study should include a minimum of 25% of patients with darker skin complexions, an increase from the previous 15%.
- Pigmentation Evaluation: The pigmentation of each study participant should be evaluated using at least two different methods, including a researcher's evaluation and a scientific, light-based measurement of melanin levels.
Michelle Tarver, director of the FDA’s Center for Devices and Radiological Health, stated that the draft recommendations are based on the best available science to address concerns about disparate performance of pulse oximeters related to skin pigmentation.
Impact and Scope
The FDA's recommendations apply specifically to professional pulse oximeters used in hospitals, clinics, and other medical settings. The agency does not regulate over-the-counter oximeters, which are typically considered "general wellness" devices.
While the guidelines do not mandate the removal of older devices currently in use, the FDA expects manufacturers to provide new diversity data when seeking changes or updates to these devices. The FDA plans to list online pulse oximeters labeled as having non-disparate performance.
Background
Pulse oximeters are non-invasive devices that measure blood oxygen saturation by sending light wavelengths into the skin. Studies have indicated that inaccuracies in pulse oximeter readings can lead to missed cases of hypoxemia (low blood oxygen levels) in individuals with darker skin. A 2021 study, for instance, revealed that pulse oximeters tended to overestimate oxygen levels in Black patients, potentially delaying necessary treatment and increasing health risks.
The FDA first issued a warning about potential inaccuracies in pulse oximeters in 2021, and the issue has since become a focal point in discussions about racial biases in medical technology.
Next Steps
The draft guidance is open for public comment for 60 days, after which the FDA will begin work on finalizing the guidelines.
