FDA Lays Out Guidelines Regarding Pulse Oximeter Accuracy Across Skin Tones

To assist in ensuring that pulse oximeters function appropriately across all skin tones, the Food and Drug Administration (FDA) has released a series of much-awaited guidelines to the industry.

The new draft directions document that the agency has released comes after multiple discussions involving the FDA’s panel of outside advisers in the past few years. It also follows up on a safety notice that was issued in 2021, at a time when equipment for reading blood oxygen levels was becoming increasingly popular with the general public during the prime phase of the COVID-19 pandemic.

During that period, the FDA issued a warning that although pulse ox devices have the potential to be beneficial, the light-based fingertip readers may not be accurate when used by individuals with darker skin. Furthermore, the results may vary due to factors such as poor circulation, the use of tobacco products, fingernail polish, and variations in the thickness of the skin as well as its temperature.

To tackle these issues, the FDA has issued guidance that directs producers on how to enhance clinical trial patterns and verification attempts for pulse oximeters created for hospitals and doctor’s offices. More specifically, the FDA recommends increasing the number of individuals participating in studies who are representative of the population. Additionally, the FDA instructs manufacturers to use both subjective and objective indicators of skin tones in laboratory tests 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, the director of the FDA’s devices center, stated.

In addition, the agency indicated that the device manufacturer ought to incorporate a statement in its labeling saying that its pulse ox reader has been found to be successful among a variety of skin tones if the accuracy of the gadget is shown in a premarket application.

The FDA has also announced that it intends to develop a public portal that will list all medical pulse oximeters that have been approved by the FDA and exhibit equivalent performance among pigmentations.

The agency conducted two advisory committee conferences and published a discussion paper to assess the reliability of pulse oximeters and explore methods for improving and assessing their performance, factoring in an individual’s skin tone. The FDA took into account feedback from the discussion paper and advisory panel sessions when formulating these tentative recommendations.

The agency collaborated with academic institutions to carry out two FDA-funded prospective clinical trials assessing pulse oximeter precision in adults and young patients (21 and younger) with diverse skin pigmentation. The methodology of the investigations supported the agency’s suggested strategy for accurately capturing and measuring skin pigmentation.