FDA Approves New Oxygenation Parameter for Masimo Pulse Oximetry Platform
Masimo, a leader in patient monitoring solutions, has announced that the FDA has granted a De Novo for ORi™, a noninvasive parameter designed to offer additional insights into a patient’s oxygen status under supplemental oxygen. ORi is enabled by Masimo’s rainbow® Pulse CO-Oximetry platform and is intended for use alongside oxygen saturation (SpO2) to provide enhanced resolution in monitoring oxygenation. This development marks ORi as the first parameter cleared by the FDA for helping clinicians manage oxygen in adults undergoing surgery in perioperative hospital settings.
Both hypoxia and normoxia can be continuously and noninvasively monitored using pulse oximetry, while assessing hyperoxia has historically required invasive and intermittent arterial blood gas analysis (aBGA). However, the introduction of the oxygen reserve index (ORi) has enabled the noninvasive assessment of a portion of the hyperoxic range. ORi is a dimensionless index, ranging from 0 to 1, that reflects the oxygenation status of mild hyperoxia (PaO2 approximately 100-200 mmHg). This advancement in monitoring allows healthcare professionals to better understand and manage patients’ oxygenation levels without the need for invasive procedures for the assessment of hyperoxia, particularly in the mild range.
Several studies have demonstrated the utility of ORi, showing it can provide advance indications of decreasing PaO2 even when SpO2 is still high. For example, the Prospective Evaluation of a RIsk Score for Postoperative Pulmonary COmPlications in Europe (PERISCOPE) study revealed that approximately 4.2% of surgical patients experience postoperative respiratory failure, which is associated with a significant in-hospital mortality rate of 10.3%, in contrast to the low 0.4% mortality in other patients. The study also identified specific risk factors that increase the likelihood of developing postoperative respiratory failure. The study found high-risk surgical patients, such as those undergoing bariatric surgery, could benefit from ORi monitoring.
Overall, ORi monitoring can reduce the time patients spend in a state of hyperoxia. The availability of ORi monitoring in the U.S. is expected to positively impact patient care, helping clinicians detect changes in oxygenation before desaturation occurs.