Pulse Oximeter Accuracy and Limitations: FDA Safety Communication

U.S. Food and Drug Administration sent this bulletin at 02/19/2021 01:58 PM EST

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US Food and Drug Administration

Pulse Oximeter Accuracy and Limitations: FDA Safety Communication 

Today, the U.S. Food and Drug Administration (FDA) issued a safety communication to inform patients and health care providers that pulse oximeters have limitations and a risk of inaccuracy under certain circumstances.

Read the Safety Communication

The safety communication provides:

  • Important recommendations for patients and their caregivers on how to use pulse oximeters at home.
  • Recommendations for health care providers on how to use pulse oximeters for better accuracy.
  • Background on pulse oximeters and the FDA’s actions to evaluate factors that may affect pulse oximeter accuracy and performance.
  • Instructions for reporting problems with pulse oximeters to the FDA.

Questions?

If you have questions, contact the Division of Industry and Consumer Education.