Masimo announced that the Food and Drug Administration (FDA) has granted clearance for the TFA-1 Single-Patient-Use Adhesive Forehead Sensor that allows clinicians to monitor patients using Masimo SET Measure-through Motion and Low Perfusion pulse oximetry from the forehead instead of a finger.
Masimo SET measures oxygen saturation (SpO2), pulse rate (PR), perfusion index (PI), and PVI, a measure of the dynamic changes in PI that occur during the respiratory cycle. Where low perfusion and motion artifacts can limit conventional pulse oximetry, the Masimo SET utilizes the power of adaptive filters to decrease measurement inaccuracy.
Oxygen saturation measurements as detected from the forehead may be less likely to be affected by peripheral perfusion changes. A study in 2004 showed that forehead sensors had faster detection of desaturation and resaturation when compared to digit sensors. Also, forehead sensors can be easily accessed during surgery and resuscitation as well as for patients with finger deformities or whose fingers are not accessible.
TFA-1, a single-patient-use sensor, does not require cleaning, storage or inter-department transport that is usually associated with reusable sensors.