Masimo (NASDAQ: MASI) announced today the CE marking and launch in western Europe of Masimo SafetyNet Alert™, an arterial blood oxygen saturation monitoring and alert system designed for use at home.

Masimo SafetyNet Alert™ features Signal Extraction Technology^® wearable fingertip pulse oximetry sensor that communicates wirelessly to an accompanying Home Medical Hub and smartphone app.

Masimo SafetyNet Alert™ monitors blood oxygen saturation (SpO₂) and pulse rate (PR) using clinically proven Masimo SET^® Measure-through Motion and Low Perfusion™ pulse oximetry and perfusion index (Pi). The system provides escalating alerts when drops in oxygen levels are detected, designed to wake up the person suffering from opioid overdose and if they do not, to send alerts to others when help may be needed.

Over 200 million people are monitored with Masimo SET^® pulse oximetry in hospitals each year.¹ In hospitals, continuous Masimo SET^® oxygen saturation monitoring has been shown to reduce harm associated with opioids in multiple clinical trials, including a 10-year study in which researchers at Dartmouth-Hitchcock Medical Center found that the use of Masimo SET^®-based continuous patient surveillance monitoring resulted in zero opioid-related preventable deaths or brain damage in their post-surgical wards. The researchers also found there was a reduction in rapid rescue events by 60%, a reduction in ICU transfers by 50%, and an estimated $7 million annually in cost savings.^2-4

Opioids are powerful painkillers, and are commonly used as part of recovery after surgery and for patients with chronic pain, but they can also slow or stop one’s breathing, potentially leading to heart attack, brain damage, and even death. In 2020 the number of drug-related deaths recorded in England and Wales rose to 4,561, the highest since records began, and around half of these involved opioids.⁵ Worldwide, that number is even worse, with an estimated more than 100,000 people dying from opioid overdose each year.⁶ Whether taking prescription or non-prescription opioids, people can suffer from the condition known as opioid-induced respiratory depression (OIRD) to varying degrees.⁶ Opioid overdose may occur while a person is particularly vulnerable, while asleep, and the risk of opioid overdose-related death is heightened for people taking opioids for the first time, those who have sleep apnea, COPD, or asthma, along with those who combine opioids with alcohol or other sedatives, amongst other factors.^6-8 By monitoring a person’s oxygen saturation level, especially while asleep, and providing escalating alerts when help may be needed, Masimo SafetyNet Alert can help identify life-threatening opioid overdose before it causes lasting harm or even death.

Masimo SafetyNet Alert leverages the same SET^® pulse oximetry technology and a similar notification escalation policy used in hospitals to bring hospital-proven monitoring to the home setting. The system provides escalating visual and audible alerts on the smartphone app and at the Home Medical Hub station, which are designed to alert the patient or anyone nearby to help prompt action. If oxygen levels continue to decline, designated emergency contacts, such as friends and family members, are also notified via text messages, so that they can intervene or involve Emergency Medical Services as needed.

Masimo SafetyNet Alert brings to the home the breakthrough Masimo SET^® pulse oximetry used in hospitals around the world. SET^® has been clinically proven to help care teams enhance patient safety and improve patient outcomes; in fact, more than 100 independent and objective studies have shown that Masimo SET^® outperforms other pulse oximetry technologies during motion and low perfusion conditions, providing clinicians with increased sensitivity and specificity to make critical care decisions.⁹

Dr. Mike Durkin, a Senior NHS Advisor on Patient Safety Policy and Leadership for the National Institute for Health Research (NIHR) Imperial College Patient Safety Translational Research Centre, said, “Patients recovering from surgery still need pain relief using opioid drugs after they are discharged from hospital and return home. However, these drugs have significant side-effects, particularly on the depression of breathing, which without urgent intervention can result in serious harm or death. The technology is now available to monitor the impact of opioids on breathing and it is vital that patients are given the opportunity to easily and continuously monitor their oxygen levels and vital signs while taking these medications at home. This will greatly improve the safety of patients while rehabilitating at home.”

Yvonne Gardner, mother of 21-year-old Parker Stewart, who died of an opioid overdose after taking only half of the prescribed dose of painkillers following a tonsillectomy, said, “I’ve had so many people call me personally and say, what would you do differently? My son needs a tonsillectomy, or my daughter is going into surgery. I tell them: make sure your doctor gives you a monitor.”

Joe Kiani, Founder and CEO of the company, said, “30 years ago, we had the dream of improving patient outcomes and reducing the cost of care by taking noninvasive monitoring to new sites and applications. Bringing our measure-through motion and low perfusion pulse oximetry to the home to monitor patients taking opioids is fulfilling that dream in a way that I could not have imagined at the time. I hope tens of thousands of lives will be saved each year from opioid overdose with the launch of Masimo SafetyNet Alert.”

Masimo SafetyNet Alert has not received FDA 510(k) clearance and is not available for sale in the United States.