Pulse Oximeter Accuracy and Limitations - FDA.gov

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Doctors have long known that pulse oximeters are less accurate in estimating blood oxygen levels in non-white patients, but the discrepancies were considered insignificant. The COVID-19 pandemic exposed some of the real dangers of these flaws, as the devices gave falsely high oxygen readings in patients with dark skin.

"The FDA announced a virtual meeting of the CDRH Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee on November 1, 2022, from 9 a.m. to 6 p.m. Eastern Time. For additional meeting details, see the meeting announcement in the Federal Register. 

The committee will discuss ongoing concerns that pulse oximeters may be less accurate in individuals with darker skin pigmentations. The committee will also discuss factors that may affect pulse oximeter accuracy and performance, the available evidence about the accuracy of pulse oximeters, recommendations for patients and health care providers, and 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."

Source:  Pulse Oximeter Accuracy and Limitations: FDA Safety Communication - FDA.gov

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