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 sever 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 hear disease: a Swedish prospective screenign 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.

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

PLCO-000941/PLM-10297B-0417