Masimo SET®: Advancing Patient Safety

The accuracy and reliability of Masimo SET® pulse oximetry has been studied in challenging conditions.

 

Masimo - Baby

  • > Masimo SET® pulse oximeters detected approximately 10 times more true events than other “Next Generation” pulse oximeters studied.1,2
  • > Researchers showed time to reliable oxygen saturation readings during neonatal resuscitation was approximately 50 seconds faster using Masimo SET® than using other pulse oximetry technologies.3
  • > In a PACU, Masimo SET® had a greater than 50% reduction in false alarms compared to other pulse oximetry technology.4
  • > In two NICU settings, Masimo SET®, coupled with changes in clinical practice, showed significantly reduced rates of severe retinopathy of prematurity (ROP) and decreased the need for laser treatment to 0%.5,6
  • > In a study of 39,821 infants, CCHD screening sensitivity increased from 63% with physical exam alone to 83% with physical exam and Masimo SET® pulse oximetry.7
  • > In a study of 122,738 infants, critical congenital heart disease (CCHD) screening sensitivity increased from 77% to 93% with the combined use of Masimo SET® and clinical assessment.8
  • > On a post-surgical unit, rescue calls and ICU transfers were reduced by 65% and 48%, respectively, after the implementation of continuous surveillance monitoring with Masimo SET®.9

“I saw and was conquered. I was not able to defeat the Masimo SET® pulse oximeter using all the motion and low pulse tricks I know. This technology is most impressive and should be available in all oximeters.”

John Severinghaus, M.D.
Professor of Anesthesiology, Emeritus University of California, San Francisco
 

Clinical Studies: The Performance of Masimo SET®

CCHD Screening

  • > When combined with clinical assessment, Masimo SET® improved critical congenital heart disease (CCHD) screening sensitivity to 93%10
Improved Critical Congenital Heart Disease Screening Sensitivity vs. Clinical Assessment Alone
Improved Critical Congenital Heart Disease Screening Sensitivity vs. Clinical Assessment Alone Chart
 

Retinopathy of Prematurity

  • > Masimo SET®, coupled with changes in clinical practice, led to a significant reduction in rates of severe Retinopathy of Prematurity (ROP)11
Severe Retinopathy of Prematurity Rate
Severe Retinopathy of Prematurity Rate Chart
 

Performance During Motion and Low Perfusion

  • > Masimo SET® had 3% missed true alarms and 5% false alarms versus 43% and 28%, respectively, using competitor technology12 *

*Results shown are calculated by combining sensitivity and specificity outcomes of machine-generated and volunteer-generated motion.

Performance During Motion and Low Perfusion
Performance During Motion and Low Perfusion Chart

References

  • 1 Hay WW. Reliability of conventional and new oximetry in neonatal patients. J of Perinatol, 2002;22:360-36.
  • 2 Barker SJ. “Motion-Resistant” Pulse Oximetry: A comparison of new and old models. Anesth Analg. 2002;95(4):967-72.
  • 3 Baquero H et al. Avoiding Hyperoxemia during Neonatal Resuscitation: Time to Response of Different SpO2 Monitors. Acta Paediatr. 2011 Apr;100(4):515-8.
  • 4 Malviya S et al. False Alarms and Sensitivity of Conventional Pulse Oximetry Versus the Masimo SET® Technology in the Pediatric Postanesthesia Care Unit. Anesth Analg 2000; 90(6):1336-1340.
  • 5 Castillo 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.
  • 6 Sola et al. Can changes in clinical practice decrease the incidence of severe retinopathy of prematurity in very low birth weight infants? 2003;111(2):339-345.
  • 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;338:a3037.
  • 8 Zhao et al. Pulse oximetry with clinical assessment to screen for congenital heart disease in neonates in China: a prospective study. Lancet. 2014 Aug 30;384(9945):747-54.
  • 9 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.
  • 10 Zhao et al. Lancet. 2014 Aug 30;384(9945):747-54.
  • 11 Castillo et al. Acta Paediatr. 2011 Feb;100(2):188-92.
  • 12 Shah et al. J Clin Anesth. 2012;24(5):385-91.

Resources

Product Information Masimo SET Product Information
Masimo SET
Product Information Masimo SET Reduced Cost of Care Product Information
Masimo SET Reduced Cost of Care

For professional use. See instructions for use for full prescribing information including indications, contraindications, warnings and precautions. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

PLCO-001785/PLM-10297C-0318