U.S. Senator Ron Wyden this week with colleagues Senators Elizabeth Warren, D-Mass., Cory Booker, D-N.J., Ed Markey, D-Mass., and Tammy Duckworth, D-Ill., implored the U.S. Food and Drug Administration (FDA) to initiate a post market study of pulse oximeters to ensure they are effective across racially diverse patients and consumers.
Recent studies have shown that inaccurate results from pulse oximeters are more likely when used to monitor people of color, particularly patients with darker skin. The device’s inconsistency could have life threatening consequences for patients, and this may have been exacerbated by the COVID-19 pandemic. One particular study found that patients of color received less supplemental oxygen than their white counterparts due to pulse oximeters’ inaccurate measurements. Wyden has also introduced the Algorithmic Accountability Act to address bias in automated systems.
“There are decades of research showing inaccurate results when pulse oximeters are used to monitor people of color, particularly patients with darker skin,” Wyden and the lawmakers said in a letter to Dr. Robert Califf, Commissioner of Food and Drugs at the FDA. “Therefore, we are seeking information from the FDA on your clearance of pulse oximeters and urge the FDA to initiate a post market study for these devices to understand what improvements to the technology will make the devices effective on the full range of human skin pigmentation.”
The lawmakers commended FDA’s new safety communication about pulse oximeter accuracy and welcomed the recent news that FDA is planning to convene a public meeting of the Medical Devices Advisory Committee later this year. This request follows up on a previous letter sent by Wyden, Warren and Booker in January of last year. However, FDA has yet to respond.
In addition to a post market study, the lawmakers request that the FDA respond fully to a series of inquiries no later than August 26, 2022.
The full text of the letter is here.