Compatibility of Alternate-Source Pulse Oximeter Sensors
February 15, 2017 | Evaluations & Guidance
One of our member hospitals reported that it had been approached by several suppliers offering pulse oximeter sensors for much less than its pulse oximeter supplier charges. These alternate-source sensors are not recommended by the hospital's oximeter supplier for use with its product. But as long as the sensors have U.S. Food and Drug Administration (FDA) marketing clearance or CE marking from the European Commission, the hospital wondered if it still had to worry about the sensors' compatibility with its pulse oximeters.
Our answer: FDA clearance or CE marking for a pulse oximeter sensor to be marketed as a replacement for an OEM (original equipment manufacturer) sensor indicates that the alternate-source supplier has demonstrated to the proper authority adequate performance and safety of the sensor as a replacement part. However, such clearance doesn't guarantee that the sensors will be...