Masimo SET® Pulse Oximetry Helps Form Basis of Utah Senate Resolution on Postoperative Oxygen Saturation Home Monitoring for Patients Prescribed Opioids

SALT LAKE CITY--(BUSINESS WIRE)--The Utah State Legislature and Governor Gary Herbert have recently signed into law the Concurrent Resolution on Deaths From Opioid-Induced Postoperative Respiratory Depression (SCR4). The resolution urges hospitals, clinicians, and researchers to examine and identify possible links between opioids and respiratory depression following surgery and encourages doctors to prescribe home monitoring for applicable patients, which may alert caregivers to low oxygen saturation (SpO₂) and changes in breathing which can precede cardiac arrest and death. Pulse oximetry technology was used in the case studies that helped shape the legislation, providing lawmakers with compelling evidence of the need for postoperative home SpO₂ monitoring of patients who are prescribed opiate painkillers.

SCR4 is commonly referred to as “Parker’s Bill” in memory of Parker Stewart, a 21-year-old newlywed who tragically passed away in his sleep three days after tonsillectomy surgery, as a result of respiratory depression believed to be caused by opioid painkillers, of which he had taken only half the prescribed dose.

Researchers at Uintah Basin Medical Center and Intermountain Healthcare – Dr. Michael Catten, Shay Uresk, BSRT, RRT, SDS, and Kim Bennion, MsHS, RRT, CHC – have been investigating the utility of home pulse oximeter use on postoperative patients. Several case studies – using Masimo (NASDAQ: MASI) SET^® Measure-through Motion and Low Perfusion™ pulse oximetry and rainbow Acoustic Monitoring^® with RRa^® – helped illustrate the benefits of postoperative monitoring for respiratory depression. Their work formed the basis for what became “Parker’s Bill,” SCR4.

“Even at normal doses, opioids can cause respiratory depression and death, and yet, the technology to monitor patients who are taking opioids is minimally expensive,” commented Dr. Catten. “Home monitoring can save thousands – not a few, thousands – of lives a year. SCR4 passed unanimously through all committees and houses of the Utah legislature, without dissent, and I hope we’ll be able to get other states onboard with similar home monitoring resolutions.”

Moving forward and in accordance with the recommendations made in SCR4, clinicians at Uintah Basin Medical Center and Intermountain Healthcare are now prescribing home SpO₂ monitoring using Masimo technology and devices, such as Rad-97™ Pulse CO-Oximeters^®. Taking advantage of Rad-97’s advanced connectivity capabilities when used together with Masimo Patient SafetyNet™*, a remote supplemental patient surveillance and clinician notification system, doctors are able to remotely monitor their at-home patients for signs of respiratory depression in real time, as an added precaution.

“This technology is a game changer,” notes Dr. Catten. “The ability to observe and communicate with patients from afar is key. It’s like having your own EMT by your side at home, watching to make sure you’re okay after surgery. I’m so grateful to the engineers who work so hard to develop this technology, which has the potential to save so many lives.”

In a landmark study at Dartmouth-Hitchcock Medical Center in New Hampshire, researchers found that continuous monitoring of adult post-surgical patients using Masimo SET^® on Masimo bedside devices, in conjunction with Masimo Patient SafetyNet, resulted in a 65% reduction in rapid response team activations and a 48% reduction in transfers back to the ICU.¹ Over five years, they achieved their goal of zero preventable deaths or brain damage due to opioids,² and over ten years, they maintained a 50% reduction in unplanned transfers and a 60% reduction in rescue events, despite increase in patient acuity and occupancy.³

Joe Kiani, Founder and CEO of Masimo, commented, “We are so happy to see Utah lawmakers recognize the suffering and death that unmonitored postoperative use of prescription painkillers can lead to – and the lives that continuous SET^® pulse oximetry monitoring can help to save. Masimo is honored to have been part of the research and the solution surrounding passage of this historic legislation. We hope other states and countries will follow in addressing this important patient safety issue.”

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

References

1. 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.
2. Taenzer AH et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
3. 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.

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

1. 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.
2. 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.
3. 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.
4. Taenzer AH et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
5. 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.
6. Estimate: Masimo data on file.
7. 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 SET^®. 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 SET^®, 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.