 FDA warns about limitations and accuracy of pulse oximeters
February 19, 2021
Dear International Colleague,
The following quote is attributed to William Maisel, M.D., MPH, director of the Office of Product Evaluation and Quality, in the FDA’s Center for Devices and Radiological Health:
“The FDA has issued a safety communication today to inform the public and health care providers of the limitations of these devices and to encourage individuals to pay close attention to all of their health symptoms, particularly if they are experiencing signs of low oxygen saturation levels, such as shortness of breath or bluish coloring of the face, lips, or nails. Patients should contact their health care provider with any concerns about increasing or worsening symptoms.
While pulse oximeters may be useful for estimating blood oxygen levels, these devices have limitations that can result in inaccurate readings. Patients with conditions such as COVID-19 should not rely solely on pulse oximeter measurements to monitor their health at home as they are not a substitute for a medical diagnosis by a health care provider.
The FDA uses a variety of data sources, including review of scientific literature, reports of adverse events and device malfunctions, and routine inspections of medical device manufacturing facilities, to monitor the safety and effectiveness of marketed medical devices. We will continue to monitor these sources for events associated with prescription pulse oximeters and are committed to keeping the public apprised of any significant new information.”
Additional Information:
- Today, the U.S. Food and Drug Administration issued a safety communication to inform patients and health care providers that pulse oximeters have limitations and a risk of inaccuracy under certain circumstances. A pulse oximeter, a device that is usually placed on a fingertip, uses light beams to estimate the amount of oxygen carried in the blood (oxygen saturation) and the pulse rate. Typical oxygen saturation values are between 95% and 100% for most individuals, but sometimes can be lower in people with lung problems.
- The safety communication identifies several factors that can affect the accuracy of a pulse oximeter reading, including poor circulation, skin pigmentation, skin thickness, skin temperature, current tobacco use and fingernail polish.
- In addition, the FDA provides important recommendations for patients and their caregivers on how to properly use pulse oximeters at home, as well as information for health care providers on how to take and interpret the readings for these devices.
- Prescription oximeters undergo FDA review and are available only with a prescription. The FDA requires that these pulse oximeters undergo clinical testing to confirm their accuracy. They are most often used in hospitals and doctors’ offices, although they may sometimes be prescribed for home use.
- Over-the-counter oximeters are sold directly to consumers in stores or online as general wellness products or for sports or aviation use. These devices are not intended for medical purposes and do not undergo FDA review.
- The FDA also advises patients to contact a health provider if they have serious or worsening symptoms or are concerned about their pulse oximeter readings.
Additional Resources:
Pulse Oximeters - Premarket Notification Submissions [510(k)s]: Guidance for Industry and Food and Drug Administration Staff
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