Irvine, California-based Masimo Technologies, which makes non-invasive patient monitoring devices and sensors, has received FDA 510(k) clearance for its forehead sensor.
The adhesive TFA-1 Forehead Sensor was developed to allow clinicians to monitor patients using pulse oximetry technology from an alternative site instead of a finger. Forehead sensors are easier to access during surgery and resuscitation, and the single-use intention of the TFA-1 negates the necessity for cleaning, storage and inter-department transport that is required of reusable sensors.
Beyond ease of use, forehead sensors are also appealing as they may provide oxygen saturation measurements that are less susceptible to peripheral perfusion changes.
Masimo’s technology, SET, is used on over 100 million patients per year at many of the country’s top 10 hospitals. SET includes measurement of oxygen saturation, pulse rate, perfusion index, and a measure of the dynamic changes in perfusion index that occur during the respiratory cycle.
The FDA has given Masimo clearance to introduce the TFA-1 disposable forehead sensor that lets clinicians get pulse oximetry readings from the forehead instead of the fingertip. The device uses Masimo’s proprietary SET Measure-through Motion and Low Perfusion technology to provide accurate readings that rival traditional pulse oximeters. It can measure oxygen saturation (SpO2), pulse rate (PR), perfusion index (PI), and PVI, changes in the perfusion index that occur due to breathing.
Measuring oxygen saturation at the forehead may help avoid local inconsistencies caused by taking readings at the tip of one of the appendages. According to Masimo, a study published in 2004 showed that the forehead provides earlier signs of oxygen desaturation and resaturation than readings taken at the finger.
Moreover, people with injured fingers are often a challenge for finger pulse oximeters, and forehead sensors can be much easier to access for clinicians.