FDA Says It’s Continuing to Evaluate Pulse Oximeters’ Race-Related Accuracy and Limitations

June 27, 2022

More than a year and a half after a report (https://www.nejm.org/doi/10.1056/NEJMc2029240) suggesting a potential racial bias in pulse oximeter technology first surfaced as a letter to the editor in the New England Journal of Medicine (NEJM), on June 21, 2022, the U.S. Food and Drug Administration (FDA) said (https://www.fda.gov/medical-devices/safety-communications/pulse-oximeter-accuracy-and-limitations-fda-safety-communication?utm_medium=email&utm_source=govdelivery) that it is continuing its investigation into the devices’ accuracy and performance, particularly among people of color.  

FDA Says It’s Continuing to Evaluate Pulse Oximeters’ Race-Related Accuracy and Limitations

The agency initially reported (https://www.fda.gov/medical-devices/safety-communications/pulse-oximeter-accuracy-and-limitations-fda-safety-communication) the concerns about pulse oximeter accuracy on February 19, 2021, after researchers wrote in the December 2020 NEJM letter that the devices can be less accurate when reading oxygen saturation in people with dark skin pigmentation. In today’s update, FDA said that it will convene a public Medical Devices Advisory Committee (MDAC) meeting later in 2022 as a forum to discuss  pulse oximeter accuracy, recommendations for patients and healthcare providers, the data manufacturers should provide to assess accuracy, and other regulatory actions.

Although they’re useful for estimating blood oxygen levels, pulse oximeters have limitations and a risk of inaccuracy under certain circumstances, FDA said. Patients and caregivers who use them for home monitoring should pay attention to all signs and symptoms of their condition and communicate any concerns to their healthcare providers.

When taking a reading with a pulse oximeter, FDA recommended (https://www.fda.gov/medical-devices/safety-communications/pulse-oximeter-accuracy-and-limitations-fda-safety-communication) that patients and healthcare providers:

When interpreting a reading, FDA said (https://www.fda.gov/medical-devices/safety-communications/pulse-oximeter-accuracy-and-limitations-fda-safety-communication) that consumers and providers should:

FDA also advised patients and caregivers to contact their healthcare providers immediately with concerns about pulse oximeter readings, other signs and symptoms of low oxygen, or other new or worsening symptoms.

Patients and providers have two types of pulse oximeter (https://www.fda.gov/medical-devices/safety-communications/pulse-oximeter-accuracy-and-limitations-fda-safety-communication) options:

Additional analysis of premarket data, as well as working with manufacturers and testing laboratories to analyze additional postmarket data, is ongoing, according to FDA (https://www.fda.gov/medical-devices/safety-communications/pulse-oximeter-accuracy-and-limitations-fda-safety-communication). Based on its findings, FDA said it may reassess the content of its pulse oximetry guidance document.

On September 15, 2022, FDA announced (https://www.fda.gov/medical-devices/safety-communications/pulse-oximeter-accuracy-and-limitations-fda-safety-communication?utm_medium=email&utm_source=govdelivery) that the Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee will hold a virtual meeting on November 1, 2022, from 9 am–6 pm EST, to discuss pulse oximeters’ accuracy for individuals with darker skin pigmentations. The agenda includes factors that may affect pulse oximeter accuracy and performance, accuracy-related evidence, recommendations for patients and healthcare providers, and data from manufacturers to assess accuracy and guide other regulatory actions.

The agency is accepting public comments by December 1, 2022. The committee will review any received before October 18, 2022. For information on submitting comments, see the announcement in the Federal Register (https://www.federalregister.gov/documents/2022/09/15/2022-19943/anesthesiology-and-respiratory-therapy-devices-panel-of-the-medical-devices-advisory-committee)

FDA said it’s continuing to evaluate all available information about pulse oximeter accuracy and performance. Its recommendations have not changed, and it will continue to keep the public informed as new information becomes available.

Healthcare professionals should report any adverse reactions or quality problems (https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program/reporting-serious-problems-fda) they suspect are associated with the use of pulse oximeters to MedWatch, FDA’s Safety Information and Adverse Event Reporting Program.

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