FDA to Hold Advisory Committee Hearing on Problems with Pulse Oximeters
A panel of scientific advisors will be convened by the U.S. Food and Drug Administration (FDA) sometime this year, to evaluate concerns about the accuracy of pulse oximeters for patients with darker skin.
On June 21, the agency announced that public meeting of the Medical Devices Advisory Committee will be held tp review evidence about use of the devices among different types of patients, and provide recommendations about any regulatory steps that should be taken to reduce the risk of problems with pulse oximeters.
Pulse oximeters are devices placed on the patient’s finger to detect oxygen levels by the way the light is absorbed by the skin. The devices help with triage and treatment decisions for many medical conditions, and have been one of the critical tools for monitoring patients during the COVID-19 pandemic, providing one of the first measures of an individual’s decline.
The information stems from a study published in 2020, which suggested that pulse oximeters provide dangerous misreads for Black patients. In fact, Black patients are nearly three times more likely to receive inaccurate or false readings from pulse oximeters compared to white patients.
Furthermore, a study published this year indicated, as a result of the inaccurate pulse oximeter readings, Black and Latino patients often are not diagnosed with COVID-19 and receive life-saving treatment much later than white patients. The study indicated the devices overestimated blood oxygen levels among Asian, Black and Latino patients, leading to treatment delays among all three groups.
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Research dating back to the 1990s highlighted the prevalence of disparities when using pulse oximeters among patients of color, but the devices still have not been updated.
The FDA advisory committee plans to offer recommendations for patients and health care providers, as well as the amount and type of data that should be provided by manufacturers to assess pulse oximeter accuracy and to guide other regulatory actions as needed.
The goal of meetings are to provide independent expert advice when evaluating regulated products and to help the FDA make decisions backed by scientific information and available evidence.
While the FDA is not required to follow the recommendations put forth by the advisory committee, the agency often does. The FDA plans to continue to evaluate all available information regarding factors that may affect pulse oximeter accuracy and performance and how this may be remedied.
Details regarding the Advisory Committee meeting will be announced in the coming weeks. The committee is planning to convene later this year.
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