U.S. regulator aims to improve accuracy of blood oxygen devices for range of skin tones
The U.S. Food and Drug Administration has proposed new guidance for devices used to monitor blood oxygen levels in order to enhance their accuracy and performance across various skin tones. This move comes in response to concerns regarding the disparity in performance of these devices based on an individual’s skin pigmentation.
The updated guidance recommends that manufacturers conduct clinical trials to assess the accuracy of device performance across a range of skin tones. Additionally, the FDA is urging manufacturers to increase the number of participants on whom these devices are tested to ensure comprehensive evaluation.
Michelle Tarver, director of the FDA’s Center for Devices and Radiological Health, stated, “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.” The aim of these recommendations is to ensure that pulse oximeters provide accurate readings for all individuals, regardless of their skin tone.
It is important to note that the proposed guidance would apply specifically to oxygen monitoring devices known as pulse oximeters that are used for medical purposes. Devices sold for general wellness purposes and not reviewed by the FDA would not be subject to these guidelines.
The FDA’s efforts to improve the accuracy and performance of blood oxygen monitoring devices highlight the importance of ensuring that medical devices are effective for all individuals, regardless of their skin tone. By addressing concerns related to skin pigmentation, the FDA is taking steps to enhance the quality and reliability of these critical healthcare tools.
