FDA issues proposed guidance for improving reliability of pulse oximeters
The U.S. Food and Drug Administration (FDA) has published a new draft guidance aimed at improving the reliability of pulse oximeters, which the agency warned in 2021 are “less accurate in people with dark skin pigmentation.”
The draft guidance is now open for public comment and offers manufacturers advice on how to design and test pulse oximeters to ensure they function effectively on patients with darker skin, poor circulation, or who may be wearing fingernail polish. The agency also notes that oximeter readings can vary based on factors like skin thickness and temperature.
To address these concerns, the FDA recommends specific parameters for clinical designs to improve the effectiveness of the laser-based readings of pulse oximeters. Additionally, the agency instructs manufacturers to make their clinical trials more robust to properly test the efficacy of the devices.
“The recommendations are being provided to inform the performance evaluation of these devices, to support premarket submissions—regardless of submission type—and to promote consistency and facilitate efficient review of these submissions,” the FDA wrote. “Among other topics, the draft guidance also provides recommendations for labeling, which are intended to promote the safe and effective use of pulse oximeters and help users understand the benefits and risks associated with the device.”
The guidance comes after multiple meetings with panels of outside advisers, aimed at better understanding the issues surrounding the use of pulse oximeters. Concerns were initially raised about the devices’ clinical reliability during the COVID-19 pandemic, when doctors and patients paid more attention to blood-oxygen readings.
The FDA also plans to launch a web tool that will list all devices demonstrating clinical efficacy based on real-world data and testing on individuals with varying skin thickness and pigmentation. This publicly available website will identify all medical pulse oximeters cleared by the agency.
Public comment is open until March 10, and a final draft is expected later this year.
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