Covidien announces US FDA clearance of Nellcor respiration rate software
18 April 2012
Covidien has announced FDA has granted 510(k) clearance to market the Covidien Nellcor Respiration Rate Version 1.0 software and the Adult Respiratory Sensor.
Covidien gained CE Mark in 2011 and began to market it throughout the European Economic Area. The Company plans a limited market release in the US, starting this month, which will allow select hospitals to be the first to use the new technology.
“Respiration rate is a critical vital sign that can be the first indicator of a change in patient condition that may require immediate assessment or intervention,” said Scott Kelley, MD, Chief Medical Officer, Respiratory and Monitoring Solutions, Covidien. “Despite its clinical importance, current methods of respiration rate monitoring are not always adequate. The addition of Respiration Rate to the Covidien Nellcor Respiratory Function portfolio provides a more holistic monitoring solution using a single, integrated sensor.
"Instead of merely knowing a patient’s blood oxygen levels, we can now look at aspects of ventilation, or the passing of air into and out of the body. This gives healthcare professionals a more complete picture of a patient’s respiratory status, so they can provide effective treatment and maintain patient safety.”
“We are pleased to receive 510(k) clearance to market the new Covidien Nellcor Respiration Rate software in the United States. This important milestone reflects Covidien’s commitment to continued innovation in patient monitoring to improve clinician efficiency, respiratory care and patient safety,” said Robert J. White, President, Respiratory and Monitoring Solutions.
Continuous monitoring of respiration rate is especially important for adult patients receiving medication for post-operative pain management, who are at increased risk for respiratory complications. New conclusions and recommendations from the Anesthesia Patient Safety Foundation (APSF) suggest continuous electronic monitoring of oxygenation and ventilation for these patients to reduce the risk of unrecognized, clinically significant respiratory complications.
The APSF also recommends that continuous monitoring should integrate multiple physiologic parameters to detect clinically significant respiratory changes earlier and more reliably.1 The Covidien Nellcor Respiration Rate software may help clinicians meet APSF’s recommendations for managing this patient population.