Pulse oximeters have limitations and a risk of inaccuracy under certain circumstances. In many cases, the level of inaccuracy may be small and not clinically meaningful; however, there is a risk that an inaccurate measurement may result in unrecognized low oxygen saturation levels. Therefore, it is important to understand the limitations of pulse oximetry and how accuracy is calculated and interpreted. It is important to be aware that multiple factors can affect the accuracy of a pulse oximeter reading, such as poor circulation, skin pigmentation, skin thickness, skin temperature, current tobacco use, and use of fingernail polish.
Read the entire safety alert on the FDA website here.
