Medical Device Daily
Non-invasively measuring hospitalized patients' vitals indicators of distress – is key to avoiding complications, sentinel events and the associated high care costs. Masimo (Irvine, California) continues to target this niche, this week expanding its monitoring offerings with FDA clearance of its Masimo Rainbow SET Acoustic Monitoring system, which reports continuous respiration rates.
"There's a huge need for this for post-surgical patients on the general floor because almost all of these patients get some post-procedure analgesic, typically in the form of opioid pumps," Paul Jansen, VP of marketing for Masimo told Medical Device Daily. "When they get these patient-controlled analgesia (PCA) pumps, they give themselves more and more doses and that causes suppressed breathing. Masimo Rainbow SET Acoustic Monitoring enables earlier detection of respiratory compromise and patient distress."
The respiration monitor is added to the company's Measure-Through Motion and Low-Perfusion pulse oximetry, known as Masimo SET, which seeks to eliminate false alarms and increase pulse oximetry's ability to detect life-threatening events. That's in addition to Masimo Rainbow SET Pulse CO-Oximetry, a noninvasive blood monitoring platform that can measure many blood constituents that previously required invasive procedures.
Jansen said that while these are all light-based monitors, Acoustic Monitoring uses sound to monitor a patient's breathing.
"The sensor is placed on the side of a patient's neck and, when they breathe, the upper airway vibrates," he said. "It transmits through the skin. The sensor itself has an acoustic transducer to pick up those sounds."
Masimo reports that this is the first acoustic sensor of its type on the market. Jansen values that the potential worldwide market for the sensor at $1 billion.
The potential clinical benefits, he said, are in patient safety and a reduced number of sentinel events which are preventable with monitoring.
"This is something hospitals are focused on every day," he said. "There's obviously a cost to implement, but there's a significant reduction in cost of care."
When a patient experiences respiratory distress that's caught in time, resuscitation is performed and then the patient is typically sent to intensive care for a longer, more expensive hospital stay.
To illustrate the value of such monitors, he cited a study of the company's companion Patient SafetyNet remote monitoring and clinician notification system, which combines the SET pulse oximetry with optional Oridion Microstream end tidal CO2-based respiration rate monitoring at the point of care and wireless clinician notification via pager to provide an unmatched level of patient safety on general care floors.
Clinicians at Dartmouth-Hitchcock Medical Center (Lebanon, New Hampshire) reported that Patient SafetyNet reduced rescue activations by 65% and ICU transfers by 48%. For some patients an ICU transfer was avoided, length of stay was also reduced from 5.8 to 3.6 days with an associated cost of care reduction of 30%.
In all, the hospital physicians estimated that 163 ICU days are saved annually using the system as reported at the Society for Technology in Anesthesia (STA; Milwaukee) annual meeting in January 2009. And the system didn't include the added respiratory monitors, which could push those savings even higher, Jansen said.
Masimo Rainbow SET Acoustic Monitoring works via a single-use adhesive sensor with an integrated acoustic transducer that is applied to the patient's neck to detect upper airway acoustic vibrations. Using acoustic signal processing that leverages Masimo's Signal Extraction Technology (SET), the respiratory signal is separated and processed to display continuous respiration rate.
Acoustic Monitoring can optimally be used in conjunction with Masimo Rainbow SET Pulse CO-Oximetry and the Masimo Patient SafetyNet Remote Monitoring and Clinician Notification System to wirelessly monitor up to 80 patients at once.
Jansen said the Masimo Rainbow SET Acoustic Monitoring will cost about $4,000 to $5,000, with related software costing about as much, and then the single-use sensors will be in the $25 to $30 range and are expected to last about three days for each patient.
The company is conducting a limited release as part of efforts to garner feedback to refine the product prior to a full-scale roll-out.
Lynn Yoffee, 770-361-4789;