Dangerously wrong oxygen readings spur FDA scrutiny

The FDA continues to be concerned that pulse oximeters may be less accurate and provide dangerously wrong oxygen readings in individuals with darker skin pigmentations. The COVID-19 pandemic has caused an increase in the use of pulse oximeters, and recent reports suggest that the devices may be less accurate in people with dark skin pigmentation.

Performing post-market surveillance on scientific literature shows this report by Sjoding et al. that suggests that the pulse-oximetry devices may be less accurate in people with dark skin pigmentation. In fact, as far back as 1991 there have studies that showed the unreliability of pulse oximeters to estimate absolute SaO2 in black men (R. Jorge Zeballos , and Idelle M. Weisman). In July of this year it was also reported by Eric Raphael Gottlieb et al that Asian, Black, and Hispanic patients had higher pulse oximetry readings and were administered significantly less supplemental oxygen for a given average hemoglobin oxygen saturation compared with White patients.

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. The FDA will 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.

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