FDA Clears Masimo for Continuous RRp Monitoring

Masimo announced today that continuous RRp (respiration rate from the photoplethysmograph) monitoring of adult and pediatric patients with Rad-97, Radical-7, and Radius-7 Pulse CO-Oximeters has received FDA clearance. With this clearance, both continuous and spot-check RRp are now available in the US, supported in a variety of pulse oximetry sensors and configurations, including the new non-cabled, tetherless, wearable Radius PPG.
 
The availability of continuous RRp adds to Masimo’s portfolio of respiration rate monitoring modalities to help clinicians ensure they have the right tools for each patient scenario.
 
Determining RR, or the number of breaths taken per minute, in many situations typically requires manually counting breaths with a timer and then converting to a rate per minute, or being fitted with chest leads or straps that can be inconvenient. Acoustic respiration rate, RRa, has been shown to be an accurate^1,2, reliable¹, easy-to-use¹, and easy-to-tolerate^1,3 method of monitoring respiration rate on a continuous basis. If RRa or RRc is not available, however, for patients whose arterial oxygen saturation (SpO2) is already being monitored using Masimo SET, RRp offers a convenient way to accurately obtain RR. RRp is particularly well suited to lower acuity settings like the general ward, where patients are less likely to have respiration rate monitoring technologies available. In scenarios where the ability to detect respiratory pause is important, such as during surgery or recovery after surgery, RRp should not be used; RRa or RRc is more appropriate.
 
With breathing difficulty generally considered one of the earliest signs of patient deterioration, Masimo hopes that the availability of RRp may be able to play a role in assisting clinicians and public health officials as they seek to combat respiratory-related illnesses, including the coronavirus COVID-19, especially when applying an additional sensor is not an option.
 
Alongside RRp, Masimo SET sensors offer Measure-through Motion and Low Perfusion SET pulse oximetry, which has been shown in over 100 independent and objective studies to outperform other pulse oximetry technologies.⁴ SET is estimated to be used on more than 150 million patients a year⁵ and is the primary pulse oximetry at 9 of the 10 hospitals that top the 2019-20 U.S. News and World Report Best Hospitals Honor Roll.⁶
 
Joe Kiani, founder and CEO of Masimo, said, “We aim to provide clinicians with the best monitoring tools so that they can provide the best care possible – which means recognizing that a monitoring method that works particularly well in one patient scenario may not be available or be the best choice in another. With the introduction of continuous RRp to our devices in the US, we are finally able to give clinicians in our home country a powerful third way to monitor respiration rate continuously, complementing other methods with a convenient and cost-effective single-sensor solution.”
 
References
^1. Macknet MR et al. Accuracy and Tolerance of a Novel Bioacoustic Respiratory Sensor in Pediatric Patients. Anesthesiology. 2007;107:A84 (abstract).
^2. Goudra BG et al. Comparison of Acoustic Respiration Rate, Impedance Pneumography and Capnometry Monitors for Respiration Rate Accuracy and Apnea Detection during GI Endoscopy Anesthesia. Open J Anesthesiol. 2013;3:74-79.
^3. Patino M et al. Accuracy of Acoustic Respiration Rate Monitoring in Pediatric Patients. Paediatr Anaesth. 2013 Sep 3.
^4. Published clinical studies on pulse oximetry and the benefits of Masimo SET® can be found on our website at http://www.masimo.com. Comparative studies include independent and objective studies which are comprised of abstracts presented at scientific meetings and peer-reviewed journal articles.
^5. Estimate: Masimo data on file.
^6. http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.