The Food and Drug Administration (FDA) recently released long-awaited guidance on how manufacturers should test and label pulse oximeters, devices that measure blood oxygen levels, particularly in people with darker skin tones. The new guidelines aim to address concerns about the accuracy of these devices in diverse populations.
The document recommends testing the devices on a larger and more diverse group of people, with a focus on different skin tones. Previous guidelines asked for 200 data points, while the new guidelines suggest submitting 3,000 data points. The recommended sample size for studies has also been increased from 10 people to 150 or more.
Rather than relying on subjective judgments of skin tones, the draft guidance suggests using the Monk Skin Tone scale and the individual typology angle (ITA) scale, which is based on spectrophotometric measurements. The FDA stipulates that testing should include individuals with light, medium, and dark skin tones, with at least 25% of participants in each group and half of the dark-skin tone group representing very dark skin.
The new guidance comes after years of research showing that pulse oximeters may work less accurately on patients with darker skin, leading to potential disparities in healthcare outcomes. The FDA’s recommendations aim to address these issues and promote equality in medical device performance across all skin tones.
While the guidelines are not legally enforceable, manufacturers seeking FDA approval are expected to follow them. The agency is seeking public feedback on the guidelines before finalizing them. The proposed guidance includes recommendations for testing devices used in healthcare settings and addressing concerns about devices approved under the 510(k) submission pathway.
Some experts believe that the new guidelines may not go far enough in addressing the disparities in pulse oximeter accuracy. They emphasize the importance of testing devices on the patients they are intended for, especially those in hospital settings. The FDA also plans to maintain a list of devices that have been shown to work equally well on all skin tones to promote transparency and help healthcare providers make informed decisions.
Overall, the new guidance is a step in the right direction towards addressing racial disparities in medical devices. However, some stakeholders are calling for stronger enforcement mechanisms to ensure manufacturers comply with the guidelines and improve the accuracy of pulse oximeters for all individuals, regardless of skin tone.
