According to the Masimo website, Masimo is “a global medical technology company that develops and manufactures innovative noninvasive patient monitoring technologies, medical devices, and a wide array of sensors. We believe that Masimo SET^® helps clinicians monitor in excess of approximately 100 million patients in healthcare settings around the world, and is the primary pulse oximetry technology at 17 of the top 20 hospitals listed in the 2017-2018 U.S. News & World Report Best Hospitals Honor Roll.

PPAHS asked Masimo to answer the questions that we posed to manufacturers of continuous monitoring devices. PPAHS questions are in blue.

Masimo’s answers are below in green (provided March 13, 2018). These answers have been prepared by Steven J. Barker, PhD, MD; Chief Science Officer of Masimo Corporation.

All links were accessed July 18, 2018.

Parameters Monitored

What physiologic parameters of the patient does your device monitor for?

SET = SpO2, PR, Pi, PVi

rainbow = RRa, SpHb, SpMet, SpCO, SpOC

NIBP = NIBP SYS, NIBP DIA, NIBP PR, NIBP MAP

Temperature = Temp

Capnography = EtCO2, FiCO2, RR

O3 Regional Oximetry = rSO₂, ∆Base, AUC, ∆SpO₂

SedLine Brain Function Monitoring = EEG Waveforms, PSi, EMG, ART, SR, DSA with SEFR and SEFL

What evidence is there that your device provides a reliable and early indicator of deterioration of the patient’s condition or decline?

Patient SafetyNet (SET technology) [See 4. below for additional SET studies]

• Taenzer et al, “Impact of pulse oximetry surveillance on rescue events and intensive care unit transfers: a before-and-after concurrence study” https://www.ncbi.nlm.nih.gov/pubmed/20098128
• Taenzer et al, “APSF Newsletter 2012” 

rainbow Technology Parameters – SpHb (Hemoglobin), RRa (Acoustic Respiratory Moniotoring), SpCO (Carboxyhemoglobin), SpMet (Methemoglobin)

• Martin et al, “Noninvasive Hemoglobin Monitoring: A Rapid, Reliable, and Cost-Effective Method Following Total Joint Replacement”
• Frasca et al, “Accuracy of a Continuous Noninvasive Hemoglobin Monitor in Intensive Care Unit Patients”
• Akyildiz B.J., “Noninvasive Measurement of Hemoglobin Using Spectrophotometry: Is it Useful for the Critically Ill Child?“
• García-Soler et al, “Noninvasive hemoglobin monitoring in critically ill pediatric patients at risk of bleeding”
• Yamada et al, “The Relative Trending Accuracy of Noninvasive Continuous Hemoglobin Monitoring during Hemodialysis in Critically Ill Patients”
• Ramsay et al, “The accuracy, precision and reliability of measuring ventilatory rate and detecting ventilator pause by rainbow acoustic monitoring and capnometry“
• Patino et al, “Accuracy of acoustic respiration rate monitoring in pediatric patients“
• Roth et al, “Accuracy of noninvasive multiwave pulse oximetry compared with carboxyhemoglobin from blood gas analysis in unselected emergency department patients“
• Hampson, N.B., “Noninvasive pulse CO-oximetry expedites evaluation and management of patients with carbon monoxide poisoning“
• Annabi et al, “Severe methemoglobinemia detected by pulse oximetry“

SedLine –Brain Function Monitoring  

• Goudra et al, “Propofol and non-propofol based sedation for outpatient colonoscopy-prospective comparison of depth of sedation using an EEG based SEDLine monitor“
• Applegate et al, “Advanced Monitoring Is Associated with Fewer Alarm Events During Planned Moderate Procedure-Related Sedation: A 2-Part Pilot Trial”

O3 – Regional Oximetry

• Redford et al, “Absolute and trend accuracy of a new regional oximeter in healthy volunteers during controlled hypoxia“

Best Clinical Usage

What is the target population for your equipment?

• Medical-Surgical Floor (General Floors)
• ICU
• ED
• NICU
• PACU

Is there a patient condition, clinical unit, or area that you believe that your device provides an earlier indication of patient deterioration vs. your competitors?

Studies done at DHMC [Dartmouth-Hitchcock Medical Center] show effectiveness of SafetyNet when used to continuously monitor patients in post-surgical units and medical units.

Reducing Adverse Events and Patient Deaths – Have your customers experienced a reduction in serious adverse events (“near misses”) or patient deaths using your device? This may be evidenced by a reduction in use of naloxone, decreased transfers to the ICU, reduction in length of stay, etc.

Yes. Significant reductions in rapid response team activations and ICU transfers were observed in an 11-month evaluation of Patient SafetyNet on a post-surgical unit. Rescue events decreased 65%, from 3.4 to 1.2 per 1,000 patient discharges, and ICU transfers decreased 48%, from 5.6 to 2.9 per 1,000 patient days after implementation. Results drove expansion of the use of Patient SafetyNet to other care areas. Since expansion, no patients suffered irreversible, severe brain damage or died as a result of respiratory depression from opioids over a 5-year period.

Patient Satisfaction

How is your device connected to the patient?

SET pulse oximetry = finger probe (optional ear cavum, ear lobe, and forehead sensors available)

rainbow pulse co-oximetry = finger probe (same probe will also measure SET)

rainbow acoustic monitoring (RRa) = acoustic probe which adheres to the neck

NomoLine Capnography = cannulas (multiple available: single prong, nasal, oral/nasal, with and without O2 delivery or all available)

NIBP: Radial cuff for application on upper arm

Temp: Probe for axillary, oral, and rectal applications available

O3 Regional Oximetry: Forehead application

SedLine Brain Function Monitoring: Forehead application

What patient feedback have you had regarding use of your device? Have there been any patient recommendations for improvement? Have these recommendations been included in your device design.

Product enhancements are handled and reviewed and assessed internally. Select product enhancement ideas have been incorporated where practical.

Alarm Fatigue

Does the monitor alarm at the bedside only or is it centrally monitored?

Both options are available

Have clinicians using your device experienced an increase in the number of alarms sounding? Identify the number or percentage of alarms in terms of criticality.

The sensitivity and specificity of the SET pulse oximetry technology is demonstrated in the clinical studies referenced below across various care settings:

• Time to reliable readings during neonatal resuscitation was approximately 50 seconds faster with Masimo SET compared to other pulse oximetry. Baquero H, et al, “Avoiding hyperoxemia during neonatal resuscitation: time to response of different SpO2 monitors“
• • Masimo SET oximeters detect approximately 10 times more true events than any other “Next Generation” pulse oximeter. Barker, S.J., “Motion-resistant” pulse oximetry: a comparison of new and old models“
• In a study of 122,738 infants, the combined use of Masimo SET and clinical assessment increased CCHD detection sensitivity from 77.4% to 93.2%. Zhao et al, “Pulse oximetry with clinical assessment to screen for congenital heart disease in neonates in China: a prospective study“
• A significant reduction in severe Retinopathy of Prematurity (ROP) from 13% to 5% resulted from a change in clinical practice in combination with Masimo SET. Castillo et al, “Prevention of retinopathy of prematurity in preterm infants through
  changes in clinical practice and SpO2 technology”
• In the PACU Masimo SET pulse oximetry had a greater than 50% reduction in false alarms compared to conventional pulse oximeters. Malviya et al, “False alarms and sensitivity of conventional pulse oximetry versus the Masimo SET technology in the pediatric postanesthesia care unit“ 
• Masimo SET had 3% missed true alarms and 5% false alarms versus 43% and 28% respectively with conventional technology. Shah et al, “Performance of three new-generation pulse oximeters during motion and low perfusion in volunteers“ 

What advice do you provide your customers to help distinguish between actionable and non-actionable alarms?

Training on all aspects of the device are provided upon installation. The devices and systems are customizable to adjust alarm limits to meet hospital standards.

Interoperability – Does your device interface with other technologies, such as EHR or other monitoring devices?

Yes, both the bedside monitors and SafetyNet central station are ICSA labs certified to communicate using IHE profiles. The SafetyNet system can be interfaced to HL7 based Patient Data Management Systems (e.g. EHR, EMR, AIMS, etc.). Both bedside devices and SafetyNet central station are Cerner iBus certified. These technologies will also connect to existing middleware technologies such as, Nanthealth and Capsule. The bedside devices also have an open interface for development of connections via a third party.

Engineering/Design – Did the design of your device include input from human factors engineers, clinicians, or hospital biomedical department? If so, what was that input and how did it affect the marketed version of your device?

Yes. 

Recalls – Have there been product recalls of this equipment? If yes, when, what were the key safety issues, and what was the resolution?

No, this product has not been recalled.

Training – What training, on-going staff education, equipment troubleshooting, and other assistance do you provide your customers to ensure their use of your device is kept up-to-date and state of the art in terms of high quality patient care delivery?

Masimo provides on-site training and 24/7 technical support via phone standard with all equipment purchases.

Install Base – In North America, approximately how many patients are monitored each day using your monitoring equipment?

More than 1,000,000 patients are monitored with Masimo SET technology in a given day in North America

Equipment Usage – Approximately what are the percentages that your equipment is being used in:

1. ICU
2. PACU
3. Med-surg
4. Pediatrics
5. General care floor
6. Telemetry or step down units
7. During conscious sedation or MAC (Monitored Anesthesia Care)
8. In healthcare facilities other than at a hospital (e.g. ambulatory surgical settings, surgi centers, outpatient clinics that provide endoscopy capabilities)
9. ______ (pls provide details)

Masimo technology is used in all care areas where pulse oximetry is necessary, including in all of the above mentioned areas. Masimo SET is the primary pulse oximetry technology at 17 of the top 20 US hospitals as listed in the 2017-18 US News and World Report Best Hospitals Honor Roll.

Equipment Costs (approximates are acceptable)

What is the cost per patient per day to monitor with your equipment? Is there a specific ICD 10 code or bundled payment code which applies to your device?

Pricing and reimbursement varies based upon a variety of factors.

Have your customers seen a return on their investment? (please specify parameters for measuring ROI).

Based on the Taenzer et al study, “Postoperative Monitoring – The Dartmouth Experience,” the financial impact from the implementation of the patient surveillance system (Patient SafetyNet) resulted in annual opportunity cost savings of $1.48 million.

This Guide is moderated by the Physician-Patient Alliance for Health & Safety. The statements and opinions expressed in this guide are solely those of the manufacturer’s representative and of any health experts cited. Such statements and opinions do not represent the opinion of the Physician-Patient Alliance for Health & Safety, its staff or its board of advisors.