The FDA has published a set of long-awaited recommendations to the industry to help ensure pulse oximeters work correctly across all skin tones.
The agency’s new draft guidance document comes after two separate meetings of the FDA’s panel of outside advisers in recent years—and follows up on a 2021 safety notice, as the hardware for reading blood oxygen levels became increasingly popular with the public at the height of the COVID-19 pandemic.
At that time, the FDA cautioned that while pulse ox devices can be useful, the light-based, fingertip readers may be inaccurate among users with darker skin in addition to providing varying results due to poor circulation, tobacco use and fingernail polish, plus differences in skin thickness and temperature.
To address those concerns, the FDA’s guidance instructs manufacturers on how to improve clinical trial designs and validation efforts for pulse oximeters designed for hospitals and doctors' offices—namely by increasing the number of representative participants in studies—as well as using both subjective and objective measures of skin tones in lab experiments and real-world data.
“Our draft recommendations are based on the best available science to help address concerns of disparate performance of pulse oximeters based on an individual’s skin pigmentation,” Michelle Tarver, M.D., Ph.D., director of the FDA's devices center, said in a statement.
Additionally, the agency said that if accuracy is demonstrated in a premarket submission, the devicemaker should include a statement in its labeling that its pulse ox reader has been shown to be effective among diverse skin tones.
The FDA also said it plans to launch a public webpage that will identify all agency-cleared medical pulse oximeters that demonstrate comparable performance across pigmentations.