Masimo Receives FDA Clearance of Continuous RRp Monitoring

Masimo announced 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 diverse portfolio of respiration rate monitoring modalities – acoustic respiration rate (RRa^®), NomoLine^® capnography (RRc™), and now photoplethysmographic respiration rate (RRp^®) – 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. In addition to RRp, RRc, and RRa, Masimo offers a wide range of noninvasive and continuous monitoring technologies – including arterial oxygen saturation (SpO₂), carboxyhemoglobin (SpCO^®), methemoglobin (SpMet^®), and total hemoglobin (SpHb^®), as well as spot-check thermometry with the non-contact infrared thermometer TIR-1™ – designed to help clinicians monitor key physiological characteristics throughout the continuum of care, whether at the doctor’s office, during triage in the emergency room, on the general floor, or in the ICU. To support these technologies, Masimo provides a variety of single-patient-use sensors (and non-contact technology in the case of TIR-1), which help mitigate the risk of patient-to-patient transmission of communicable diseases.

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.
7. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO₂ Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
8. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;Jan 8;338.
9. Taenzer AH et al. Impact of pulse oximetry surveillance on rescue events and intensive care unit transfers: a before-and-after concurrence study. Anesthesiology. 2010:112(2):282-287.
10. Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
11. McGrath SP et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.

Source: Masimo