June 24, 2021
MDDI Online features Can Real-World Data Help Us Avoid Racial Bias in Medical Technologies? written by Arash Samimi, PhD, StarFish Medical Systems Engineer, in the June 23, 2021 online edition.
Subtitled: We need to adopt collaborative development strategies to collect real-world data and then use it as feedback to avoid racial bias in our medical device technologies, the article examines the impact of racial bias in pulse oximeters.
Samimi notes: “There are many manufacturers and models available. A quick search of oximeters on the web brings up the latest FDA communications about oximeter accuracy and limitations.1 A 2020 correspondence article in the New England Journal of Medicine suggests that oximeters “may be less accurate with people with dark skin pigmentation.” 2 The original correspondence states that “in two large cohorts, Black patients had nearly three times the frequency of occult hypoxemia (low level of oxygen) that was not detected by pulse oximetry as White patients.” This, in turn, can increase the risk of hypoxemia among patients with darker skins.
This observation highlights the need for real-world data and evidence that includes a true reflection of the diversity of the population to be treated.”