The Automation of Neonatal Critical Congenital
Heart Disease (CCHD) Screening Across More Than 370 Healthcare
Facilities Is Expected to Improve the Process of Screening More
Than 550,000 Newborns Annually by 2020
Recently at Arab Health 2019, the Saudi Arabia Ministry of
Health (MOH) and Masimo (NASDAQ: MASI) jointly announced the
implementation of an automation solution designed to streamline the
process of critical congenital heart disease (CCHD) screening of
newborns using Masimo SET®, the first automation of its kind
worldwide. This latest phase in Saudi Arabia’s national CCHD
screening program, which began in 2016 as part of the Vision 2030
plan addressing improvements in healthcare and other areas,
automates the collection and storage of screening data, helping to
make the process both more efficient and more accurate.
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Masimo Rad-97™ with Eve™ (Photo: Business
Wire)
In 2016, Saudi Arabia implemented a mandatory CCHD screening
program for all newborns using the Masimo Eve™ Newborn Screening
Application on Radical-7® Pulse CO-Oximeters® with SET®
Measure-through Motion and Low Perfusion™ pulse oximetry
technology. Over 100 independent and objective studies have shown
SET® to outperform other pulse oximetry technologies.1 Crucially
for newborn health, studies – including the largest CCHD screening
study to date – have shown that SET® combined with clinical
assessment significantly improved CCHD screening sensitivity.2-3
With its ability to accurately measure through motion and low
perfusion, alongside its performance in outcome studies, SET®
stands out as the most proven and established choice of pulse
oximetry technology for clinicians and policy makers hoping to
implement CCHD screening processes. Since the program began in
2016, more than 600,000 Saudi Arabian newborns have been screened
using SET®, Radical-7, and Eve.
In 2018, Eve on Rad-97™ Pulse CO-Oximeters was added to the
program. Masimo SET®, coupled with Eve to streamline the screening
process, and now with Rad-97 and automated data collection and
aggregation, provides a powerful and the only automated CCHD
solution of its kind available worldwide. Last year alone 72
newborns were referred for CHD diagnosis and heart surgery to save
their lives, as a result of positive screening results. The
screenings are carried out at 200 medical centers operated by the
MOH, with a further 170 private hospitals adopting the screening
process in late 2018. By 2020, it is estimated that 550,000
newborns annually will be screened in Saudi Arabia.
Dr. Fahad A. Al Aql, advisor to the MOH responsible for
implementing the CCHD screening program, commented, “We are
thrilled to be able to announce that in 2018 alone, widespread use
of our national CCHD screening protocol, facilitated by Masimo
technology, caught 72 instances of CHD that might otherwise have
gone undetected. Now, in this next phase, which we plan to
implement nationwide by February, we are augmenting our screening
program with additional technology – making it the only automated
solution that uses Rad-97 and Eve – that we believe will make the
process faster, easier for clinicians to perform, and less prone to
error. Patient identification can be quickly accomplished through
barcode wristband scanning, and the results, calculated by Eve,
will be collected and uploaded to central EMRs automatically,
without the need for manual transcription. More efficient, more
accurate healthcare is a cornerstone of Vision 2030. With the
support of His Excellency the Minister of Health, Dr. Tawfiq Al
Rabiah, we are looking forward to continuing to advance the
forefront of healthcare in Saudi Arabia with this
implementation.”
Eve, available on Radical-7 and Rad-97, combines the power of
Masimo SET® pulse oximetry with an automated pre- to post-ductal
synchronization algorithm designed to reduce calculation errors
during CCHD screening. In addition, Eve simplifies the CCHD
screening process by providing visual instructions, animations, and
a detailed, easy-to-interpret display of screening results. Saudi
Arabia’s automation solution uses Masimo Iris Gateway™ to record
and transmit screening results, labeled with unique patient
identifiers for both mother and newborn, from Rad-97 and Radical-7
devices to hospital and national electronic medical record (EMR)
systems, for efficient, accurate electronic charting and data
aggregation in a unified, central health repository.
CCHD affects approximately 2.5 to 3 newborns per 1000 live
births4 and requires intervention soon after birth to prevent
significant morbidity or mortality; later detection in infants also
increases the risk of brain damage.5 In a study of 39,821 infants,
CCHD screening sensitivity increased from 63% with physical exam
alone to 83% with physical exam and Masimo SET® pulse oximetry.2 In
a study of 122,738 infants – the largest CCHD screening study to
date – CCHD screening sensitivity increased from 77% to 93% with
the combined use of Masimo SET® and clinical assessment.3
@MasimoInnovates | #Masimo
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,6 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.7-9 Masimo SET® is estimated to be used on
more than 100 million patients in leading hospitals and other
healthcare settings around the world,10 and is the primary pulse
oximetry at 9 of the top 10 hospitals listed in the 2018-19 U.S.
News and World Report Best Hospitals Honor Roll.11 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/.
Eve has not obtained FDA clearance and is not available in
the United States. Radical-7 and Rad-97 have obtained FDA clearance
and are available, without Eve, in the United States. ORi has not
received FDA 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. 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. 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. Zhao et al. Pulse oximetry with clinical
assessment to screen for congenital heart disease in neonates in
China: a prospective study. Lancet. 2014 Aug 30;384(9945):747-54.
4. Hoffman JL et al. The incidence of congenital heart disease. J
Am Coll Cardiol. 2002;39(12):1890-1900. 5. 2011 Legislative Report;
State of Maryland, Department of Health and Mental Hygiene, State
Advisory Council on Hereditary and Congenital Disorders.
Recommendations on Implementation of Screening for Critical
Congenital Heart Disease in Newborns. Page 7. 6. 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. 7. 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. 8. Taenzer A et al. Postoperative Monitoring –
The Dartmouth Experience. Anesthesia Patient Safety Foundation
Newsletter. Spring-Summer 2012. 9. 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. 10.
Estimate: Masimo data on file.
11.
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®, Radical-7®,
Rad-97™, and Eve™. 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®, Radical-7, Rad-97, and Eve,
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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Media Contact:MasimoEvan
Lamb949-396-3376elamb@masimo.com
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