Masimo (NASDAQ: MASI) today announced the results of a recently published ten-year retrospective study in which researchers at Dartmouth-Hitchcock Medical Center investigated the impact of an integrated clinical surveillance monitoring system, using Masimo SET® and Patient SafetyNet™ technologies, on mortality related to the use of prescribed opioids in the general ward. Over the ten years studied, of 111,488 patients in units with surveillance available, there were zero patient deaths and no patients were harmed by opioid-induced respiratory depression while continuous monitoring was in use. In contrast, among patients in units without surveillance available, there were three deaths.1
Masimo Patient SafetyNet™ with Root®, Radius-7®, and Replica™
The surveillance monitoring system provided continuous monitoring using Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry, and was comprised of Masimo Radical-7® and Rad-87® Pulse CO-Oximeters®, Root® Patient Monitoring and Connectivity Hubs, and Masimo Patient SafetyNet™, which provided supplemental remote monitoring at central view stations and alarm and alarm escalation notifications to clinicians' pagers. Monitored parameters included oxygen saturation (SpO2) and pulse rate (PR). The researchers reviewed ten years of data collected from 2007 to 2017, over which time there were 126,697 general care unit discharges.
Dr. Sue McGrath and colleagues at Dartmouth-Hitchcock Medical Center found that, over the 10 years, of the 111,488 patients in units with surveillance monitoring available, "none died or were harmed by opioid-induced respiratory depression when surveillance monitoring was in use." Of the 15,209 patients in unmonitored units, three patients died from opioid overdose. The reduced death rate when surveillance was available, compared to when it was not available, was statistically "significant" (p=0.03).
A fourth patient died in a unit where surveillance monitoring was available but Masimo technology was not being used at the time of the adverse event. The researchers noted, "The fact that one patient with known risk for opioid sensitivity died while in a unit where monitoring was available but not in use highlights the importance of system adoption and adherence to standards of care."
The researchers concluded, "For a 10-year period, the rescue system with continuous surveillance monitoring had a profound effect on death from sedative/analgesic administration in the general care setting. This approach to patient safety can help address the risk of sedative/analgesic-related respiratory arrests in hospitals."
Regarding the cost of deploying such a system, the researchers noted, "Although cost is often raised as a barrier to implementation, a previously performed financial analysis demonstrated cost-effectiveness of surveillance monitoring due primarily to intensive care unit patient days avoided when early detection of patient deterioration occurs."
They continued, "This study confirms that surveillance monitoring for pharmacologically induced respiratory arrest in hospitalized patients can virtually eliminate deaths due to this serious but treatable complication. In other high-risk, safety-focused industries, the level of evidence that currently exists for continuous surveillance monitoring to mitigate the risk of accidental sedative/analgesic overdose would likely prompt immediate calls for widespread implementation of safety interventions."
Joe Kiani, Founder and CEO of Masimo, commented, "We are incredibly grateful to Dr. McGrath, her colleagues, and everyone at Dartmouth-Hitchcock Medical Center for demonstrating the value of continuous monitoring of post-surgical patients over a ten-year period. Hundreds of other hospitals have adopted our technology and have reported similar results. We hope that this new study will inspire every other institution to implement Masimo SET® on their general floor to eliminate preventable deaths due to opioid overdose, especially at this time when illnesses that impact the respiratory system, such as COVID-19, are so prevalent."
In previously published studies at Dartmouth-Hitchcock Medical Center, researchers found that after deploying the continuous monitoring system in the original 36-bed unit, there was a 65% reduction in rapid response team activations and a 48% reduction in transfers back to the ICU.2 After five years of use, they reported zero preventable deaths or brain damage due to opioids, as well as cost savings of $7 million, 3 and after ten years, they reported maintaining a 50% reduction in unplanned transfers and a 60% reduction in rescue events, despite increases in patient acuity and occupancy.4
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1. McGrath S, McGovern K, Perreard I, Huang V, Moss L, Blike G. Inpatient Respiratory Arrest Associated with Sedative and Analgesic Medications: Impact of Continuous Monitoring on Patient Mortality and Severe Morbidity. J Patient Saf. 14 March 2020. DOI: 10.1097/PTS.0000000000000696.
2. 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.
3. Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
4. 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.
5. Published clinical studies on pulse oximetry and the benefits of Masimo SET® can be found on our website at https://www.masimo.com. Comparative studies include independent and objective studies which are comprised of abstracts presented at scientific meetings and peer-reviewed journal articles.
6. 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.
7. 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.
8. Estimate: Masimo data on file.