“Recent studies revealed the impact of inaccurate pulse oximeter measures in COVID-19 patients and acknowledged that it may have contributed to lower quality health care”
Washington (August 12, 2022) — Senators Edward J. Markey (D-Mass.), Elizabeth Warren (D-Mass.), Cory Booker (D-N.J.), Ron Wyden (D-Ore.), and Tammy Duckworth (D-Ill.) sent a letter to Dr. Robert Califf, Commissioner of Food and Drugs at the U.S. Food and Drug Administration (FDA), asking FDA to initiate a post market study of pulse oximeters and seeking information about the agency’s clearance process for 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.
“There are decades of research showing inaccurate results when pulse oximeters are used to monitor people of color, particularly patients with darker skin,” wrote the lawmakers. “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. However, FDA has yet to respond to Senator Warren’s earlier letter, sent in January 2021, which expressed the same concern about the medical risks people of color face due to the inaccuracy of pulse oximeters.
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.