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Joint Commission Issues Sentinel Event Alert on Opioid-Induced Respiratory Depression

August 13, 2012

IRVINE, Calif., Aug. 13, 2012 /PRNewswire/ — Masimo (NASDAQ: MASI) announced today that The Joint Commission has issued a Sentinel Event Alert on safe use of opioids in hospitals with recommendations to implement better dosing along with oxygenation and ventilation monitoring in post-surgical patients. The Masimo Patient SafetyNet(TM) System, consisting of Measure-through Motion and Low Perfusion oxygenation monitoring (Masimo SET(®) Pulse Oximetry or rainbow SET(®) Pulse CO-Oximetry), choice of easy-to-use ventilation monitoring with rainbow(®) Acoustic Monitoring or standard capnography, and remote monitoring and clinician notification to keep clinicians connected to patients, can help hospitals comply with The Joint Commission recommendations. The Patient SafetyNet System is also the only technology clinically shown to reduce rapid response activations, intensive care unit (ICU) transfers, and deaths related to opioid-induced respiratory depression.

While opioid use is safe for most patients, opioid analgesics are associated with adverse effects(1,2,3) and cause respiratory depression in 0.5% of post-surgical patients, who often receive them for pain management.(4,5,6) Opioid analgesics rank among the drugs most frequently associated with adverse drug events, the Sentinel Event Alert noted. Of opioid-related adverse drug events – including deaths – that occurred in hospitals and were reported to The Joint Commission’s Sentinel Event database (2004-2011), 47% were wrong dosing medication errors, 29% were related to improper monitoring of the patient, and 11% were related to other factors including excessive dosing, medication interactions, and adverse drug reactions.

Similar to the 2011 Anesthesia Patient Safety Foundation’s recommendations,(7) the Sentinel Event Alert recommended continuous monitoring (instead of spot checks) of both oxygenation and ventilation. Oxygenation monitoring is possible with Masimo SET(®) Measure-through Motion and Low Perfusion pulse oximetry, which is ideal for the general floor where patients are often moving and the nursing staff does not have the time to respond to false alarms. Ventilation monitoring is possible with Masimo’s rainbow(®) Acoustic Monitoring, which provides continuous respiration rate through an acoustic sensor on the neck, or standard capnography, which provides continuous respiration rate and end-tidal carbon dioxide (EtCO(2)) through a nasal cannula. While capnography is considered the clinical standard for unconscious, mechanically ventilated patients undergoing surgery, in conscious patients the nasal cannula is often not well tolerated. In addition, the nasal cannula can be become dislodged or unable to pick reliable signals when patients breathe through their mouths, requiring additional nursing staff time to manage.

In a 2010 landmark study published in Anesthesiology, clinicians at Dartmouth Hitchcock Medical Center reported that use of Masimo SET(®) pulse oximetry and Patient SafetyNet in a single orthopedic post-surgical unit led to a 65% decrease in rapid response activations and a 48% decrease in ICU transfers.(8) A follow-up analysis appearing in the Spring-Summer 2012 issue of the Anesthesia Patient Safety Foundation newsletter validated the original findings by showing similar clinical results on two additional post-surgical floors.( 9) Importantly, Dartmouth Hitchcock also reported that no patients on the original orthopedic unit have died or suffered irreversible brain injury as a result of respiratory depression from opioids since the Patient SafetyNet system was instituted in December of 2007.

Cost of care is an increasingly important factor in today’s healthcare environment. Dartmouth Hitchcock also reported that using Patient SafetyNet on just one floor reduced ICU transfers and created an annual opportunity-cost savings of $1.48 million. This demonstrates that Patient SafetyNet not only helps clinicians improve clinical outcomes, but that it does so in a cost-effective manner with benefits exceeding the cost of equipment, sensors, and training time.

Joe Kiani, Founder & CEO of Masimo, stated: “Since our founding in 1989, our mission has been to improve patient outcomes and reduce cost of care by taking noninvasive monitoring to new sites and applications. From the beginning, we observed that conscious patients were not getting the best care because they couldn’t be monitored reliably due to false pulse oximetry measurements and alarms that occurred with the natural movement of their bodies. In areas like the general floor, countless patients have tragically died due to this prior limitation of pulse oximeters. By solving the motion artifact limitation with SET(®), Masimo has ushered in an era where prestigious groups like the Anesthesia Patient Safety Foundation and The Joint Commission can now recommend monitoring of patients in new sites like the general floor, where previously patients were needlessly dying due to undetected physiologic deterioration.”

1 Vila H Jr, Smith RA, Augustyniak MJ: The efficacy and safety of pain management before and after implementation of hospital-wide pain management standards: Is patient safety compromised by treatment based solely on numerical pain ratings? Anesthesia and Analgesia, 2005;101:474-80
2 Emergency department visits involving nonmedical use of selected prescription drugs – United States, 2004-2008. Morbidity and Mortality Weekly Report 2010, 59:705-709
3 Office of Applied Studies, Substance Abuse and Mental Health Services Administration. Substance abuse treatment admissions involving abuse of pain relievers: 1998 and 2008, http://oas.samhsa.gov/2k10/230/230PainRelvr2k10.cfm (accessed October 28, 2011)
4 McPherson ML: Strategies for the management of opioid-induced adverse effects. Advanced Studies in Pharmacy, 2008;5(2):52-57
5 Jarzyna D, et al: American Society for Pain Management Nursing guidelines on monitoring for opioid-induced sedation and respiratory depression. Pain Management Nursing, 2011;12(3):118-145.e10
6 Pasero C, M McCaffery: Pain assessment and pharmacologic management. Chapter 12 – Key Concepts in Analgesic Therapy, and Chapter 19 – Management of opioid-induced adverse effects. St. Louis, Mosby Elseveir, 2011
7 Stoelting RK, Weinger MB. Dangers of Postoperative Opioids — Is There a Cure? APSF Newsletter, 2009;24:25-26. http://www.apsf.org/newsletters/html/2009/summer/index.htm
8 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
9 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 here.

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(TM) technology, allowing noninvasive and continuous monitoring of blood constituents that previously required invasive procedures, including total hemoglobin (SpHb®), oxygen content (SpOC(TM)), 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(TM), 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(TM), the first-ever noninvasive and continuous monitoring of acoustic respiration rate (RRa(TM)). 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 assumptions of the repeatability of clinical results obtained using the new Masimo Pronto-7 and noninvasive sensor sizes, risks related to our belief that the Pronto-7 enables quick and easy noninvasive spot-checking of hemoglobin (SpHb®), SpO(2), pulse rate, and perfusion index at the point-of-care for all patients, 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.

Media Contacts:
Mike Drummond
Masimo Corporation
(949) 297-7434
mdrummond@masimo.com

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.

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