Up to date, expert answers to frequently asked questions (FAQ) about oxygen supply systems, respiratory care and pulse oximetry written by OCC & collaborators.
Pulse ox validation & certification
How accurate are pulse oximeters?
For oximeters that have been approved by the US FDA, accuracy over the SpO2 range of 70-100% is within a few SpO2 percent of the actual value when tested under laboratory validation conditions (for some oximeters, performance may be different when used in various clinical conditions). Most oximeters tend to be more accurate with higher SpO2 values than lower SpO2 values.
The FDA has published guidelines for the recommended standards for pulse oximeter performance, which includes device accuracy. These guidelines require the devices to be tested with a minimum of 200 data points over an SaO2 range of 70% to 100%, and to be tested on people with different skin tones. Studies have shown that many low-cost pulse oximeters demonstrate highly inaccurate readings. However, some low-cost pulse oximeters have performed with similar accuracy to more expensive units when used in healthy subjects. However, it is important to recognize that many additional variables can make even good pulse oximeters have less accurate readings.
Keywords: accuracy, low-cost, guidelines, FDA