Market Overview

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

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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

This press release features multimedia. View the full release here:
https://www.businesswire.com/news/home/20180726005993/en/

Masimo Radius-7® Pulse CO-Oximeter® (Photo: Business Wire)

Masimo Radius-7® Pulse CO-Oximeter® (Photo: Business Wire)

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."

@MasimoInnovates |
#Masimo

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.

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