Masimo Corporation Patient SafetyNet™ and SpHb® Noninvasive Hemoglobin Monitoring Enable Clinicians To Meet New Guidance From Centers For Medicare & Medicaid Services

IRVINE, CA--(Marketwired - May 21, 2014) -

The Centers for Medicare & Medicaid Services (CMS) issued updated guidance for hospital medication administration -- effective immediately -- to reduce preventable deaths or serious adverse events related to intravenous (IV) opioid medications and blood transfusions.(1) The CMS guidance “strongly encouraged” hospitals to review best practices from safety organizations, including continuous monitoring of oxygenation and ventilation for patients receiving IV opioids.

CMS’s clarifications are provided for various provisions of 42 CFR 482.23(c), concerning medication administration, and 42 CFR 482.51(b)(4), concerning post-operative patient care.

An estimated one-third of all hospital adverse events are related to Adverse Drug Events (ADEs), affect approximately two million hospital stays annually, and prolong hospital length of stay by approximately 1.7 to 4.6 days.(2) Each year, serious adverse events, including fatalities, associated with the use of IV opioid medications occur in hospitals, CMS noted in its memorandum. It also noted hospital patients on IV opioids may be placed in units where they typically are not monitored as frequently as in post-anesthesia recovery or intensive care units, increasing the risk that patients may develop respiratory distress that will not be immediately recognized and treated.

Masimo 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.(3) Patient SafetyNet combines the performance of Masimo SET® pulse oximetry -- the enabler of reliable oxygenation and pulse rate monitoring in the general ward -- with ventilation monitoring and wireless clinician notification that 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.

For example, since implementing Patient SafetyNet in 2007, Dartmouth-Hitchcock Medical Center in Lebanon, N.H., has had zero patients die or suffer permanent brain injury due to opioid-induced respiratory depression.

After expanding post-surgical monitoring to the general and thoraco-vascular post-surgical units, Dartmouth-Hitchcock reported:

• 57% overall reduction in rescue events over all units (4.4 to 1.9 per 1,000 patient days per month)
• 168 ICU days saved in the thoraco-vascular unit in the first 12 months after implementation
• 21% decrease in average length of stay of a patient with transfer to the ICU
• $1.48 million in annual opportunity cost savings due to decreased ICU transfer rate
• $58,459 saved per patient who was not transferred to the ICU

CMS referenced the Patient Safety Movement Foundation’s Actionable Patient Safety Solutions (APSS):
The “Patient Safety Movement Foundation (PSMF) recommends all patients receiving IV opioids have continuous measure-through motion and low perfusion pulse oximetry, and that patients on supplemental oxygen also have continuous respiration rate monitoring. It also calls for the monitoring system to be linked with a notification system to clinical staff who can respond immediately. It calls for an escalation protocol so that if a staff person does not acknowledge the alert in 60 seconds a second person will be notified.”

CMS also noted safety measures from the Institute for Safe Medication Practices (ISMP) and the Anesthesia Patient Safety Foundation (APSF). ISMP makes available a list of high alert medications, which it defines as those medications that bear a heightened risk of causing significant patient harm when they are used in error. The current list may be found at: http://www.ismp.org/Tools/highAlertMedicationLists.asp

Meanwhile, the APSF calls for every patient receiving postoperative opioid analgesics to be managed based on the following clinical considerations:

• Individualize the dose and infusion rate of opioid while considering the unique aspects of each patient’s history and physical status.
• Make continuous monitoring of oxygenation (pulse oximetry) the routine rather than the exception.
• Assess the need for supplemental oxygen, especially if pulse oximetry or intermittent nurse assessment are the only methods of identifying progressive hypoventilation.
• When supplemental oxygen is indicated, monitoring of ventilation may warrant the use of technology designed to assess breathing or estimate arterial carbon dioxide concentrations. Continuous monitoring is most important for the highest risk patients, but depending on clinical judgment, should be applied to other patients.

The APSF video on opioid-induced ventilatory impairment can be seen at http://apsf.org/resources_video4.php

While opioid use is safe for most patients, opioid analgesics are associated with adverse effects(4,5,6) and cause respiratory depression in 0.5% of post-surgical patients, who often receive them for pain management.(7,8,9) Opioid analgesics rank among the drugs most frequently associated with adverse drug events, according to The Joint Commission.(10) 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.

Regarding blood transfusions, CMS stated: “Whenever IV medications and blood transfusions are administered, the patient may become at risk for fluid and electrolyte imbalance. Hospital policies and procedures must address monitoring and treatment for fluid and electrolyte imbalances that may occur with blood transfusions and IV medications,” and noted, “Blood transfusions can be life-saving. However, like IV medications, blood transfusions are not without risk of harm to patients. Transfusion reactions and/or errors can be fatal.”

Masimo SpHb® noninvasive and continuous total hemoglobin can help hospitals adhere to CMS guidance. SpHb allows clinicians to noninvasively and continuously monitor hemoglobin blood levels, and provides real-time directional trends, such as indicating stable hemoglobin when it may be perceived to be dropping, and rising hemoglobin when it may be perceived to not be rising fast enough. SpHb monitoring has been shown to help clinicians reduce the number of risky and costly blood transfusions in surgical patients, and speed up blood transfusion for those who need it.(11)

“Masimo’s noninvasive and continuous monitoring technologies have been shown to help clinicians safely and effectively monitor patients in the OR and medical-surgical floors,” said Dr. Steve Barker, M.D., Ph.D., Chairman of the Scientific Advisory Board of Masimo. “Patient SafetyNet and SpHb, in particular, can equip caregivers with the right tools to meet new CMS guidance to improve patient safety and outcomes, while also reducing the cost of care.”

1 Centers for Medicare & Medicaid Services. Survey & Certification Letter 14-15-Hospital. http://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Policy-and-Memos-to-States-and-Regions-Items/Survey-and-Cert-Letter-14-15.html
2 Draft National Action Plan for Adverse Drug Event (ADE) Prevention (2013). U.S. Department of Health and Human Services.
3 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
4 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
5 Emergency department visits involving nonmedical use of selected prescription drugs - United States, 2004-2008. Morbidity and Mortality Weekly Report 2010, 59:705-709
6 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)
7 McPherson ML: Strategies for the management of opioid-induced adverse effects. Advanced Studies in Pharmacy, 2008;5(2):52-57
8 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
9 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
10 Joint Commission Issues New Sentinel Event Alert: Safe Use of Opioids in Hospitals, Aug. 8, 2012; http://www.jointcommission.org/sentinel_event_alert_safe_use_of_opioids_in_hospitals/
11 Awada W.F.N., Maher F. Reduction in Red Blood Cell Transfusions during Neurosurgery with Noninvasive and Continuous Hemoglobin Monitoring. Proceedings of the Society for Technology in Anesthesia Annual Meeting ; 2013 Jan 9-12; Phoenix AZ. Available 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 indepensdent and objective studies have shown that Masimo SET® outperforms other pulse oximetry technologies, even under the most challenging clinical conditions, including patient motion and low peripheral perfusion. 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 Pleth Variability Index (PVI®), in addition to SpO2, pulse rate, and perfusion index (PI). 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 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 regarding the repeatability of clinical results; risks related to our belief that Masimo’s unique noninvasive measurement technologies, including total hemoglobin (SpHb), contribute to positive clinical outcomes and patient safety; 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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