New Article Showcases an Effective Surveillance System for General Care Units Using Masimo Patient SafetyNet™

Masimo (NASDAQ:MASI) announced today that a new article published in The Joint Commission Journal on Quality and Patient Safety reports on the results of an expansion of the use of Masimo Patient SafetyNet™* to more than 200 general floor beds at Dartmouth-Hitchcock Medical Center (D-H) in Lebanon, New Hampshire.1 Patient SafetyNet is a remote monitoring and clinician notification system that works in conjunction with a variety of bedside monitors, such as Masimo Root® with Radical-7® and Root with Radius-7®, powered by Masimo SET® pulse oximetry – the first Measure-through Motion and Low Perfusion™ pulse oximetry and the most accurate and reliable pulse oximeter in such conditions according to over 50 studies.2

Masimo Patient SafetyNet was first implemented in the 36-bed orthopedic unit at D-H in December 2007, as part of a surveillance strategy supporting patient safety improvement. Clinicians reported that after 11 months, rescue events had been reduced by 65% and intensive care unit transfers by 48%, and calculated annual cost savings of $1,480,000.3,4 They also announced that they had experienced zero preventable deaths or instances of irreversible seizure brain damage due to opioids since installation.4 As a result of the positive outcomes of the pilot unit implementation, D-H expanded this continuous patient monitoring approach, including the use of Patient SafetyNet, to remaining post-surgical ward units in February 2009, to medicine ward units in April 2010, and to the pediatric ward unit in February 2012. Patients in more than 200 beds are now covered by D-H’s patient surveillance system. As the authors note, “The original success in terms of patient outcomes and enthusiastic endorsement by nurses prompted request from other units for the system and led to the rapid spread of the system across the institution.” The improvements first seen in the pilot unit – in addition to the dramatic reductions in rescue events and unplanned transfers, approximately two alarms per patient per 12-hour nursing shift, and resolution of more than 85% of all alarm conditions within 30 seconds and more than 99% before escalation was triggered – have been “sustained over time in spite of increasing patient acuity (up 20% from 2010 to 2015) and unit occupancy (93% in 2015).”

Much of the initiative’s success is due to D-H’s development of a robust general care alarm management strategy, including the implementation of Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry. As the authors note, “device-level characteristics such as measurement reliability and alarm annunciation” are critical. A systematic approach to alarm management is needed because of the growing problem of “‘alarm fatigue’ – the growing desensitization of health care providers to alarms” as a result of the “growing number of monitoring devices, combined with suboptimal patient monitoring and alarm management strategies.” False and/or nonactionable alarms may occur as much as 90% of the time, according to one study5; another, involving the Philips HP Merlin M1094 monitor, found that 77% were either not recognized or ignored6; a third, involving Nellcor pulse oximetry, found an actual risk for patients in only 3% of alarm states, and that anesthesiologists have been shown to disable alarms because of high false alarm rates.7

D-H attempted to optimize several key elements of an effective alarm management strategy: 1) static alarm settings – setting thresholds based on patient groups to reduce nuisance alarms; 2) alarm delays – introducing a delay of 15 seconds before an alarm sounds, as “Many changes in physiologic parameters are brief and self-correcting”; 3) alarm threshold adjustments – adapting to “physiologic variation among different patients” by adjusting alarms based on a three-tiered system of the static defaults, independent nurse adjustments, and provider-ordered individualized settings; and 4) alarm announcement – having the alarm sent to the nurse in charge of the patient via remote pager and allowing customization of when and how alarms are escalated to additional clinicians, by which practice alarm exposure has now been reduced by almost 90%.

Important to the success of the D-H alarm management strategy was the selection of Masimo SET® and Patient SafetyNet architecture, as part of D-H’s patient surveillance system. As the authors note, a fundamental factor affecting operation of and response to clinical monitor alarms is “device-level characteristics such as measurement reliability and alarm annunciation.” As the initiative’s centrally-monitored parameter they notably chose oxygen saturation (SpO2), measured using Masimo SET® pulse oximetry, which has been shown to reduce false alarms by over 95% and increase true alarm detection to over 97%, even during motion and low perfusion.8 Regarding the choice of remote monitoring system, the authors note that “A previously installed multiparameter monitoring system on the pediatric unit was largely rejected by the staff because of alarm system issues, such as high false alarm rates, lack of directed notification, and ambiguous alarm indicators. The alarm rate [with Masimo Patient SafetyNet] was 75% lower than the alarm rate of the previous system immediately following implementation of [Masimo Patient SafetyNet], and 100% of nursing staff survey respondents were in favor of continuing use of [Masimo Patient SafetyNet]. The staff credited the robust alarm management strategy and leadership rounding with the improved system performance and high level of staff adoption.”

“Dartmouth-Hitchcock provides a compelling example of the benefits that a robust patient monitoring and surveillance system, coupled with a carefully executed strategy, can reap,” said Joe Kiani, Founder and CEO of Masimo. “It is estimated that as many as 50,000 patients die each year due to failure to rescue patients in the general ward.9 Any hospital that wants to eliminate general ward preventable deaths should read both this article and Dartmouth-Hitchcock’s original study, ‘Impact of pulse oximetry surveillance on rescue events and intensive care unit transfers: A before-and-after concurrence study,’ published in 2010.3 Together, they provide an excellent guide to designing, implementing, and maintaining a successful hospital-wide continuous monitoring system, as well as showcasing the innovative practices that have arisen out of their focus on alarm management. Dartmouth-Hitchcock’s success story, laid out in a well-executed plan and follow on analysis over nearly a ten-year period, sets a powerful precedent for other medical facilities: it’s time for all hospitals to develop hospital-wide alarm management strategies and as part of that, to implement Patient SafetyNet – to help save money and save lives.”

@MasimoInnovates | #Masimo

References

  1. McGrath, S.P., Taenzer, A.H., Karon, N, Blike, G. “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.
  2. All published clinical studies on Masimo products can be found at http://www.masimo.com/cpub/clinical-evidence.htm.
  3. Taenzer A.H., Pyke J.B., McGrath S.P., Blike G.T. Anesthesiology. 2010 Feb;112(2):282-7.
  4. Taenzer A, Blike G, McGrath S, Pyke J, Herrick M, Renaud C, Morgan J. "Postoperative Monitoring - The Dartmouth Experience." Anesthesia Patient Safety Foundation Newsletter Spring-Summer 2012. Available online.
  5. Imhoff M, Kuhls S. Alarm algorithms in critical care monitoring. Anesth Analg. 2006;102:1525-1537.
  6. Gorges M, et al. Improving alarm performance in the medical intensive care unit using delays and clinical context. Anesth Analg. 2009;108:1546-1552.
  7. Kestin IG, Miller BR, Lockhart CH. Auditory alarms during anesthesia monitoring. Anesthesiology. 1988;69:106-109.
  8. Shah N et al. J Clin Anesth 2012 Aug;24(5):385-91.
  9. HealthGrades Quality Study. Patient Safety in American Hospitals (July 2004).

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

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 by taking noninvasive monitoring to new sites and applications. 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® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. 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®), and more recently, Pleth Variability Index (PVI®) and 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. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7™ wearable patient monitor and the MightySat™ fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. All published clinical studies on Masimo products can be found at http://www.masimo.com/cpub/clinical-evidence.htm.

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 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 Patient SafetyNet, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions with comparable accuracy and unique advantages, including: immediate and continuous results that enable earlier treatment without causing invasive trauma in all patients and in every clinical situation; 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.

Contacts:

Masimo
Evan Lamb, 949-396-3376
elamb@masimo.com

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