New Study Investigates the Utility of Masimo SpHb® in Post-operative Red Blood Cell (RBC) Transfusion Best Practices
April 19 2018 - 11:01AM
Business Wire
Masimo (NASDAQ: MASI) announced today the findings of an
abstract presented at the 2018 Annual Meeting of the Network for
the Advancement of Patient Blood Management, Haemostatis and
Thrombosis (NATA), in which researchers investigated the utility of
Masimo noninvasive and continuous hemoglobin (SpHb®) in supporting
and enhancing red blood cell (RBC) transfusion best practices as
part of post-operative patient blood management (PBM).1
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Masimo Radical-7® with SpHb® and RD
rainbow SET™ Sensor (Photo: Business Wire)
In the study, Prof. Baricchi and colleagues in the Transfusion
Medicine Unit, AUSL-IRCCS of Reggio Emilia and at the Department of
Medicine and Surgery at the University of Parma, Italy, sought to
evaluate the appropriateness of post-operative RBC transfusion over
a three-year period (2013-2015), before and after implementation of
a patient blood management (PBM) program. The PBM policy consisted
of three months of training followed by the introduction of
noninvasive, continuous point-of-care (POC) monitoring of patient
hemoglobin using Masimo SpHb on Masimo Radical-7® Pulse
CO-Oximeters®. An initial audit of RBC transfusion appropriateness
was conducted prior to the introduction of the PBM policy, on 168
patients. A final audit, after the policy was in place, was
conducted on 205 patients. To determine transfusion
appropriateness, investigators used the guidelines established by
the Italian Society of Transfusion Medicine and Immunohaematology
(SIMTI).
The researchers found that prior to the introduction of the PBM
policy, 37.7% of RBC transfusions were appropriate. After the
introduction of the PBM policy, including use of noninvasive and
continuous hemoglobin monitoring with Masimo SpHb, they found 65.4%
of RBC transfusions were appropriate, a significant increase in
transfusion appropriateness.
The researchers concluded that, “In our experience, the PBM
strategies introduced improved RBC transfusion appropriateness in
the post-operative period. We believe that our PBM policy and
introduction of POC testing are a valuable support for the
healthcare workers in the transfusion decision-making process. This
enhancement of transfusion appropriateness implies clinical and
managerial advantages, such as reduced transfusion-related risks,
optimization of the health care resources and reduction of the
costs.”
SpHb is not intended to replace laboratory blood testing.
Clinical decisions regarding red blood cell transfusions should be
based on the clinician’s judgment considering among other factors:
patient condition, continuous SpHb monitoring, and laboratory
diagnostic tests using blood samples.
@MasimoInnovates | #Masimo
Reference
- Baricchi R, Marraccini C, Merolle L,
Berni P, Bonini A, Mazzi A, Pertinhez T.A., and Di Bartolomeo E.
Patient blood management: transfusion appropriateness in the
postoperative period. Proceedings from the 2018 NATA Annual
Meeting, Lisbon, Portgual. #P30.
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://www2.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
- 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.
- 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.
- 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.
- Taenzer AH et al. Postoperative
Monitoring – The Dartmouth Experience. Anesthesia Patient Safety
Foundation Newsletter. Spring-Summer 2012.
- 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.
- Estimate: Masimo data on file.
-
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 SpHb®. 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 SpHb, 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:MasimoEvan Lamb949-396-3376elamb@masimo.com
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