FDA Recommends New Pulse Oximeters Standards Due to Bias Concerns
The Food and Drug Administration (FDA) held an advisory panel discussion this month to address concerns about
the accuracy of pulse oximeters, particularly in individuals with dark skin pigmentation.
The FDA sought opinions on potential new clinical trial requirements to ensure
the accuracy of these devices across all skin tones, and there was discussion
regarding whether both prescription and over-the-counter pulse oximeters should adhere to the same standards.
In 2021, the FDA issued a warning about the “risk of inaccuracy” when using pulse oximeters on darker skinned patients.
FDA officials cited studies indicating that, in six out of
seven systematic reviews published between 2020 and 2023, pulse oximeters tended
to overestimate readings in people with dark skin pigmentation, leading to real-life consequences.
The FDA issued a recommendation that participants in clinical trials should span
the Monk Skin Tone scale, a measurement developed by Ellis Monk, an associate
professor at Harvard University, that is designed to represent a broader range
of skin tones. Currently, many studies use the Fitzpatrick scale to measure skin
pigmentation. The Fitzpatrick scale was developed by a dermatologist in the 1970s
to measure the UV sensitivity of different skin types and skews toward lighter skin tones.
The FDA also is considering a non-disparate performance
requirement to ensure the devices don’t perform differently based on skin pigmentation.
Additionally, the FDA issued a recommendation that both over-the-counter and prescription
pulse oximeters should meet the same criteria.