Devices

Senators Want Pulse Oximeter Info

Three senators are asking FDA to quickly conduct a review of the accuracy of pulse oximeters across racially diverse patients and consumers. A 1/25 letter to FDA acting commissioner Janet Woodcock from Sens. Elizabeth Warren (D-MA), Ron Wyden (D-OR), and Cory Booker (D-NJ) references a recent study suggesting that devices measuring blood oxygen levels are less accurate in Black patients with undetected low levels of oxygen in their blood when compared to White patients. They say the study authors concluded that “reliance on pulse oximetry to triage patients and adjust supplemental oxygen levels may place Black patients at increased risk for hypoxemia [which has] major implications … during the current pandemic.”

The senators say they are seeking information from FDA on the clearance or approval of pulse oximetry measurement devices that “may be biased against patients with ‘darkly pigmented’ skin.”

The letter asks for answers to these questions:

whether FDA reviewed data on the inaccuracy due to skin color of pulse oximeters, including those used in professional and in-home settings and, if so, what the agency concluded and what is the clinical significance of any inaccuracy;
for current pulse oximeters, whether FDA collected, before product clearance or approval, data on the product’s accuracy among subgroups;
whether FDA has monitored over-the-counter pulse oximetry devices sold during the Covid-10 pandemic to ensure they are marketed appropriately and the results of any monitoring;
the degree to which different cleared or approved pulse oximeters are efficacious across racial and ethnic groups;
information on a 2013 FDA guidance on pulse oximeters and recommendations for studies;
whether FDA plans to adjust accuracy requirements of future pulse oximeters seeking clearance or approval to ensure they are accurate on all patients regardless of skin color; and
whether there is evidence that other infrared medical devices that interact with a patient’s skin pigment also vary in efficacy by the patient’s race and ethnicity.

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Gupta Raises Concerns About Overton’s Independence, Ideology

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