Pulse Oximeters Safety Advisory Reminder

As we are now in respiratory illness season, it is a good time to review the 2021 FDA Safety Communication.   The FDA issued this important safety advisory aimed at both patients and healthcare providers. This advisory emphasizes the valuable role of pulse oximetry in estimating blood oxygen levels, while also highlighting the inherent limitations and potential inaccuracies associated with pulse oximeters under specific circumstances.
It is crucial to recognize that numerous factors can influence the precision of pulse oximeter readings. These factors include issues like impaired circulation, variations in skin pigmentation, differences in skin thickness, variations in skin temperature, concurrent tobacco use, and the application of fingernail polish.
Guidelines for Healthcare Providers
  • Acknowledge the multifactorial nature of factors affecting pulse oximeter accuracy, such as poor circulation, skin characteristics, tobacco use, and nail polish application.
  • Consult the device's labeling or the manufacturer's website to gain insight into the accuracy of a specific brand of pulse oximeter and its sensor. Understand that different brands and sensor types (e.g., finger clip versus adhesive) may offer varying levels of accuracy. Note that pulse oximeters are less precise when oxygen saturation falls below 80%.
  • Consider accuracy limitations when using the pulse oximeter to assist in diagnosis and treatment decisions.
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