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
DUBAI, United Arab Emirates--(BUSINESS WIRE)--Feb. 18, 2019--
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.
This press release features multimedia. View the full release here:
https://www.businesswire.com/news/home/20190218005021/en/
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-7and 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20190218005021/en/
Source: Masimo
Media Contact:
Masimo
Evan Lamb
949-396-3376
elamb@masimo.com