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The Joint Commission Issues National Patient Safety Goal and Requirements for Medical Device Alarm Management



7/8/2013 10:13:50 AM

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IRVINE, CA--(Marketwired - July 08, 2013) -

Masimo (NASDAQ: MASI) announced today that the Joint Commission has issued a National Patient Safety Goal on Alarm Management to improve the safety of clinical alarm systems, requiring hospital leaders to establish alarm safety as a hospital priority and take specific actions to help avoid patient injuries and deaths related to alarms. The National Patient Safety Goal follows the Joint Commission's recent Sentinel Event Alert on medical device alarm safety.

The Joint Commission recognizes that while clinical alarms are intended to alert caregivers to potential patient problems, if alarms are not properly managed they can compromise patient safety. According to the Joint Commission, the most common cause of alarm-related sentinel events was alarm fatigue. Alarm fatigue happens when monitoring technologies produce false alarms.

Pulse oximeters are the most common form of monitoring in most hospitals, but conventional technologies create false alarms during patient movement and in patients with poor perfusion. False alarms created by inaccurate measurements can increase nursing workload and alarm fatigue, which can lead to a delayed response, compromised care, and poor patient outcomes.(1)

Masimo SET® pulse oximetry has been shown in clinical studies to dramatically reduce false alarms(2) and increases a clinician's ability to detect life-threatening events(3) -- helping to substantially contribute to improved patient outcomes and patient safety. A side-by-side comparison published last year in the Journal of Clinical Anesthesia showed Masimo SET® pulse oximetry had higher oxygen saturation (SpO2) specificity and sensitivity and lower failure rates during conditions of motion and low perfusion than the Nellcor N-600 (OxiMax V 1.1.2.0) and the GE TruSat (formerly Datex-Ohmeda).(2)

                                                                            
                                                                            
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                        Masimo SET® (v5.0) Nellcor N-600 (v1.1.20) GE TruSat
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Missed True Alarms              3%                   43%              83%   
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False Alarms                    5%                   28%              18%   
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The ability of Masimo SET® to accurately detect oxygen saturation changes (sensitivity) and avoid false alarms (specificity) has been validated in more than 100 independent and objective studies,(2) internal studies, and thousands of clinical evaluations. Most important, only Masimo SET® pulse oximetry has been shown to improve patient outcomes by helping clinicians reduce retinopathy of prematurity, screen newborns for critical congenital heart disease,(4,5) reduce ventilator weaning time,(6) and save lives while reducing rapid response activations and intensive care unit transfers on the general floor.(3)

Hospitals can further improve patient outcomes and comply with the Joint Commission recommendations by using Masimo Patient SafetyNet™, which combines the performance of Masimo SET® pulse oximetry, the enabler of reliable monitoring in the general ward, with ventilation monitoring and wireless clinician notification. Patient SafetyNet can help ensure patients' safety by noninvasively and continuously measuring and tracking their underlying physiological conditions and changes that signal declining health status in real-time. When changes occur in the measured values, which may indicate deterioration in the patient's condition, the system automatically sends wireless alerts directly to clinicians -- prompting a potentially lifesaving response to the patient's bedside. Patient SafetyNet has been clinically shown to reduce preventable and costly rescue events, transfers to intensive care units, and deaths related to opioid-induced respiratory depression.(7)

The Joint Commission's National Patient Safety Goal of improving clinical alarm systems will be effective in two phases in 2014 and 2016:

  • As of July 1, 2014, hospital leaders establish alarm safety as a hospital priority
  • During 2014, hospitals identify the most important alarm signals to manage

As of January 1, 2016, hospitals should establish policies and procedures for managing the alarms identified that, at a minimum, address:

  • Clinically appropriate settings for alarm signals
  • When alarm signals can be disabled
  • When alarm parameters can be changed
  • Who in the organization has the authority to set alarm parameters
  • Who in the organization has the authority to change alarm parameters
  • Who in the organization has the authority to set alarm parameters to "off"
  • Monitoring and responding to alarm signals
  • Checking individual alarm signals for accurate settings, proper operation, and detectability

Joe Kiani, Founder & CEO of Masimo, stated: "We applaud the Joint Commission for focusing attention on problems with medical device alarms, which consistently rank among the top most critical health technology hazards in hospitals. We launched Masimo nearly 25 years ago with a mission to eradicate pulse oximetry false alarms -- one of the most frequent false alarms plaguing hospitals. Clinicians have told us that countless patients have tragically died due to alarm fatigue, and that the performance of Masimo SET® Pulse Oximetry is a major reason they have embraced our technology."

Dr. Michael O'Reilly, Chief Medical Officer for Masimo, stated: "By solving the pulse oximeter's motion artifact limitation with Signal Extraction Technology®, Masimo has made a huge contribution to patient care and helped push safety monitoring to areas where patients previously weren't monitored due to the significant false-alarm rate associated with conventional pulse oximetry."

1 Cvach M. Monitor Alarm Fatigue, An Integrative Review. Biomedical Instrumentation & Technology. July/August 2012.
2 Shah N, Ragaswamy H, Govindugari K, Estanol L. "Performance of three new-generation pulse oximeters during motion and low perfusion in volunteers." Journal of Clinical Anesthesia. 2012 (10.1016/j.jclinane.2011.10.012) Available online here
3 Taenzer, Andreas H.; Pyke, Joshua B.; McGrath, Susan P.; Blike, George T. "Impact of Pulse Oximetry Surveillance on Rescue Events and Intensive Care Unit Transfers: A Before-and-After Concurrence Study." Anesthesiology, February 2010, Vol. 112, Issue 2. Available online here
4 de Wahl Granelli A, Wennergren M, Sandberg K, et al. Impact of pulse oximetry screening on detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ 2009; 338: a3037.
5 Ewer A, et al. Health Technol Assess. 2012;16(2):1-184.
6 Durbin, et al. Critical Care Medicine. 2002 Aug.;30(8): 1735 to 1740.
7 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.

About Masimo
Masimo (NASDAQ: MASI) is the global leader in innovative noninvasive monitoring technologies that significantly improve patient care -- helping solve "unsolvable" problems. In 1995, the company debuted Measure-Through Motion and Low Perfusion pulse oximetry, known as Masimo SET®, which virtually eliminated false alarms and increased pulse oximetry's ability to detect life-threatening events. More than 100 independent and objective studies have shown that Masimo SET® outperforms all other pulse oximetry technologies, even under the most challenging clinical conditions, including patient motion and low peripheral perfusion. In 2005, Masimo introduced rainbow SET® Pulse CO-Oximetry™ technology, allowing noninvasive and continuous monitoring of blood constituents that previously required invasive procedures, including total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and Pleth Variability Index (PVI®), in addition to SpO2, pulse rate, and perfusion index (PI). In 2008, the company introduced Masimo Patient SafetyNet™, a remote monitoring and wireless clinician notification system designed to help hospitals avoid preventable deaths and injuries associated with failure to rescue events. In 2009, Masimo introduced rainbow Acoustic Monitoring™, the first-ever noninvasive and continuous monitoring of acoustic respiration rate (RRa™). Masimo's rainbow SET® technology platform offers a breakthrough in patient safety by helping clinicians detect life-threatening conditions and helping guide treatment options. In 2010, Masimo acquired SEDLine®, a pioneer in the development of innovative brain function monitoring technology and devices. Masimo SET® and Masimo rainbow SET® technologies can also be found in over 100 multiparameter patient monitors from over 50 medical device manufacturers around the world. Founded in 1989, Masimo has the mission of "Improving Patient Outcome and Reducing Cost of Care... by Taking Noninvasive Monitoring to New Sites and Applications®." Additional information about Masimo and its products may be found at www.masimo.com.

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 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 belief that Masimo Patient SafetyNet can help keep patients safer by noninvasively, continuously measuring and tracking their underlying physiological condition to help hospitals avoid preventable patient deaths and injuries associated with failure to rescue events, risks related to our assumptions of the repeatability of clinical results obtained, and risks related to the system's ability to significantly decrease traumatic critical events and costly ICU transfers to help improve patient outcomes and reduce costs; risks related to our belief that Masimo SET virtually eliminates false alarms and increases a clinician's ability to detect life-threatening events; 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 forward-looking 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.

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care... by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI, rainbow Acoustic Monitoring, RRa, Radical-7, Rad-87, Rad-57, Rad-8, Rad-5, Pulse CO-Oximetry, Pulse CO-Oximeter, Adaptive Threshold Alarm, and SEDLine are trademarks or registered trademarks of Masimo Corporation. The use of the trademarks Patient SafetyNet and PSN are under license from University HealthSystem Consortium.


Media Contacts:
Mike Drummond
Masimo Corporation
(949) 297-7434
Email Contact

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