New Study Investigates Impact of General Ward Clinical Monitoring Using Masimo Root®, Radius-7®, and Patient SafetyNet™ on Clinical Workflow and Patient Care

LEBANON, N.H.--(BUSINESS WIRE)--Masimo (NASDAQ: MASI) announced today the findings of a recently published study in which researchers at Dartmouth-Hitchcock Medical Center investigated the impact of an integrated clinical monitoring system, using various Masimo technologies and devices, on clinical workflow and patient care in the general ward. The researchers sought to “demonstrate the application of systems-level design and analysis to measure the impact of clinical monitoring on key workflow and system characteristics that contribute to early detection of patient deterioration.”¹

To evaluate workflow impact through use of the enhanced monitoring system, Dr. McGrath and colleagues collected data in a study unit consisting of 2 general wards with 71 beds total for five months prior to and five months after implementation. They also collected the same data for the full ten months in a control unit consisting of 2 general wards with 61 beds total, which did not have any system changes. In both the study and control units, prior to implementation, the baseline monitoring system consisted primarily of Masimo Rad-87^® Pulse CO-Oximeters^®, for continuous and spot-check (vital signs) measurements using Masimo SET^® pulse oximetry, and Masimo Patient SafetyNet™, a supplemental remote monitoring and clinician notification system, used for data processing and archiving.

The enhanced monitoring system, implemented in the study unit, added Masimo Root^® with Radius-7^® wearable Pulse CO-Oximeters. Root is a patient monitoring and connectivity platform that includes such features as built-in blood pressure and temperature measurements, a barcode reader and integration with the hospital’s admission-discharge-transfer (ADT) system, and integration with Patient SafetyNet and the hospital’s electronic medical record (EMR) system for automated capture of patient monitoring and vital signs data, including from connected third-party devices. Radius-7 is a tetherless, wearable monitor that allows patients to be mobile while still being continuously monitored, with data sent wirelessly via Bluetooth^® or WiFi to Root, eliminating the need for nurses to manually place bedside monitors in standby mode and disconnect sensors each time a patient leaves the bed.

Key points of comparison and results included:

• Monitoring system utilization: The researchers noted a significant increase in the number of hours patients were continuously monitored after implementation. Monitored hours per patient day increased from mean 17.26 hours to 19.57 hours (p < 0.0001) and monitored hours per month from mean 15,931.25 hours to 19,053.3 hours (p < 0.0001).
• Vital signs documentation: With the implementation of Root and its ability to automatically upload patient data, including pulse oximetry and blood pressure and temperature measurements, to Patient SafetyNet and the EMR, researchers noted a significant decrease in the time required to obtain and record vital signs: mean assessment time dropped from 178.8 seconds to 128.9 seconds (p < 0.0001), representing an average time savings of 3 hours per day in a 36-bed unit.
• Patient information: The researchers measured the rate at which certain patient data fields were filled out in the EMR for one month before and after implementation. Patient last name presence increased from 98.92% to 100% presence (p = 0.0083). Patient first name and room and bed presence increased from 33.75% and 57.27%, respectively, to 100% (p < 0.0001).
• Clinical staff satisfaction: Three months after implementation, hospital staff feedback was solicited in a 16-question survey which had a 65% response rate and overall “very high” satisfaction with the enhanced monitoring system.
• Alarms: The researchers found that there was a significant increase in the number of clinical alarms per patient day (rate ratio 1.46, p = 0.0263) but not per monitored hour (rate ratio 1.34, p = 0.1090), which they believe is “logical when considering [the] additional time each patient [was] monitored.”

The researchers concluded, “The enhanced monitoring system received high staff satisfaction ratings and significantly improved key clinical elements related to early recognition of changes in patient state, including reducing average vital signs data collection time by 28%, increasing patient monitoring time (rate ratio 1.22), and availability and accuracy of patient information. Impact on clinical alarms was mixed, with no significant increase in clinical alarms per monitored hour.”

In previous studies conducted at Dartmouth-Hitchcock, researchers found that continuous monitoring of adult post-surgical patients using Masimo SET^®, in conjunction with Masimo Patient SafetyNet, resulted in a 65% reduction in rapid response team activations and a 48% reduction in transfers back to the ICU.² Over five years, they achieved their goal of zero preventable deaths or brain damage due to opioids,³ and over ten years, they maintained a 50% reduction in unplanned transfers and a 60% reduction in rescue events, despite increase in patient acuity and occupancy.⁴

Joe Kiani, Founder and CEO of Masimo, said, “We are incredibly grateful to Dartmouth-Hitchcock for their continued long-term research into the utility of continuous patient monitoring on the general floor and the benefits that holistic, integrated monitoring systems can provide. Continuous monitoring of all patients on opioids is clearly the path forward, with the potential to make significant improvements in patient safety and quality of care. We look forward to continuing to learn from Dartmouth-Hitchcock’s data and to improving our technologies and integrated solutions.”

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The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References

1. McGrath S, Perreard I, Garland M, Converse K, and Mackenzie T. Improving patient safety and clinician workflow in the general care setting with enhanced surveillance monitoring. J Biomed Health Infor. DOI 10.1109/JBHI.2018.2834863.
2. Taenzer A 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.
3. Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
4. McGrath S 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.

About Masimo

Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care. In 1995, the company debuted Masimo SET^® Measure-through Motion and Low Perfusion™ pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET^® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,¹ improve CCHD screening in newborns,² and, when used for continuous monitoring with Masimo Patient SafetyNet™ in post-surgical wards, reduce rapid response activations and costs.^3,4,5 Masimo SET^® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world,⁶ and is the primary pulse oximetry at 17 of the top 20 hospitals listed in the 2017-18 U.S. News and World Report Best Hospitals Honor Roll.⁷ In 2005, Masimo introduced rainbow^® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb^®), oxygen content (SpOC™), carboxyhemoglobin (SpCO^®), methemoglobin (SpMet^®), Pleth Variability Index (PVi^®), and more recently, Oxygen Reserve Index (ORi™), in addition to SpO₂, pulse rate, and perfusion index (Pi). In 2014, Masimo introduced Root^®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect^® (MOC-9^®) interface, enabling other companies to augment Root with new features and measurement capabilities. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7^® wearable patient monitor, iSpO₂^® pulse oximeter for smartphones, and the MightySat™ fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at http://www.masimo.com/evidence/featured-studies/feature/.

ORi has not received FDA 510(k) clearance and is not available for sale in the United States.

The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References

1. 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.
2. 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.
3. 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.
4. Taenzer AH et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
5. 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.
6. Estimate: Masimo data on file.
7. http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.

Forward-Looking Statements

This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo SET^®, Root^®, Radius-7^®, and Patient SafetyNet™. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo SET^®, Root, Radius-7, and Patient SafetyNet, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions and unique advantages; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.