FDA MedWatch - Pulse Oximeter Accuracy and Limitations: FDA Safety Communication

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MedWatch - The FDA Safety Information and Adverse Event Reporting Program 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. This 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 about this safety communication, contact the Division of Industry and Consumer Education (DICE).

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