Last week, researchers warned an FDA expert panel that flawed readings from blood oxygen monitors may have caused deaths during the pandemic. A recent Vox article discussed the issue in detail, specifying that the devices don’t work well on people with darker complexions. Available in both clinical and home settings, these blood oxygen monitors are commonplace. However, after research showed that the devices don’t work as well on dark skin tones the FDA issued an alert stating that the devices have “limitations” in 2021.
The panel reviewed several of these studies and determined the inaccuracies can have real consequences for patients. This included delayed covid treatments in Black patients who weren't able to identify their lowering oxygen levels. The panel meeting focused mostly on prescription devices, but concerns are growing regarding over-the-counter “wellness” versions as well. The wellness product designation lets companies dodge regulatory scrutiny since they don’t claim the product can diagnose or treat a medical condition. The FDA panel didn’t make any formal decisions, but the conversation likely struck fear in companies that produce smartwatches with blood oxygen features such as Apple and Fitbit, both of which are in the gray “wellness” category.