Covidien, Boulder, Colo, received 510(k) marketing clearance from the US Food and Drug Administration (FDA) for the Nellcor OxiMax N-600xpulse oximeter with OxiMax SPD alert for adults. The OxiMax SPD feature enables the pulse oximeter to detect and alert clinicians of worrisome oxygen desaturation patterns, allowing them to make timely and more informed decisions about patient care.
Most current pulse oximeters supply a real-time snapshot of a patient’s oxygen saturation (SpO2) but cannot provide the added benefit of detecting patterns of desaturation that could be a useful indicator of evolving ventilatory compromise. With a high degree of sensitivity and specificity, the OxiMax SPD alert utilizes a complex algorithm to detect patterns of desaturation that are indicative of repetitive reductions in airflow.
“Demand for continuous pulse oximetry monitoring—especially for patients on opioids – is increasing across all areas of the hospital and is a vital part of balancing patient safety and pain management,” says Roger Mecca, MD, vice president, medical affairs, respiratory, and monitoring solutions at Covidien. “With the recently granted FDA clearance, Covidien introduces a new alert technology that allows us to provide early warnings of physiological conditions that may lead to respiratory issues. This enables clinicians to intervene earlier and help improve outcomes.”