Understanding the FDA's Pulse Oximeter Basics Consumer Update

On March 26, the FDA published the Pulse Oximeter Basics Consumer Update. Consumers are increasingly using pulse oximeters in-home when they are not feeling well or to monitor their general health.

Oxygen is essential for survival, and when blood oxygen levels drop too low, it can lead to serious health issues. Conditions such as asthma, lung cancer, chronic obstructive pulmonary disease (COPD), flu, and heart disease can cause low oxygen levels. Additionally, high altitudes with lower oxygen concentration can also contribute to decreased oxygen levels in the body. Monitoring oxygen levels can be crucial for individuals with respiratory or cardiovascular conditions, and one common tool used for this purpose is the pulse oximeter.

A pulse oximeter is a small device that clips onto a fingertip and uses light to estimate blood oxygen saturation (SpO2) and pulse rate. Normal oxygen saturation levels for healthy individuals range between 95% and 100%, though they may be lower for those with medical conditions or at high altitudes. When using a pulse oximeter at home, it is important to follow best practices, such as keeping hands warm, removing nail polish, staying still, and recording readings. Symptoms of low oxygen levels, like bluish skin, shortness of breath, or chest pain, should be monitored alongside pulse oximeter readings. However, factors such as skin pigmentation, circulation issues, and smoking can affect the accuracy of readings.

Pulse oximeters come in different categories, including FDA-cleared medical devices and general wellness products not evaluated for medical use. During the COVID-19 pandemic, many consumers purchased over-the-counter pulse oximeters, though these may not always be accurate. Research indicates that pulse oximeters may have accuracy variations based on skin pigmentation, prompting the FDA to issue safety communications, hold advisory meetings, and propose new guidelines for improving device performance. Individuals experiencing issues with pulse oximeters can report concerns through the FDA’s MedWatch program.