Masimo Gains CE Mark for Neonatal Noninvasive Continuous Hemoglobin Monitoring

Masimo announced the CE marking of SpHb, noninvasive and continuous hemoglobin monitoring, for neonatal and infant patients (< 3 kg). With this clearance, the benefits of SpHb are available for patients of all ages in CE mark countries. SpHb for neonates and infants is provided on rainbow sensors, which allow clinicians to simultaneously measure multiple additional noninvasive parameters alongside SpHb, including oxygen saturation (SpO₂) and methemoglobin (SpMet).
 
Because of their small size, neonates and infants have less blood than older patients. In addition, their lack of bone marrow density makes them far less capable than adults of generating new red blood cells for approximately the first eight months of life. Current invasive methodologies for measuring hemoglobin can only provide intermittent, delayed results. By providing a continuous, noninvasive measurement, SpHb allows clinicians to more closely monitor neonatal hemoglobin status in real time by tracking the stability, or instability, of a patient’s hemoglobin trend, providing visibility into changes, or lack of changes, in hemoglobin between invasive blood samples.
 
On adult patients, continuous monitoring with SpHb has been found to improve outcomes, such as reducing the percentage of patients receiving transfusions,¹ reducing the units of red blood cells transfused per patient,^2-3 reducing the time to transfusion,⁴ reducing costs,⁵ and even reducing mortality 30 days after surgery.⁶
 
In addition to hemoglobin, rainbow sensors monitor SpO₂ using Masimo SET Measure-through Motion and Low Perfusion technology, which has been shown in over 100 independent and objective studies to outperform other pulse oximetry technologies.⁷ Crucially for newborn health, SET has been shown to help clinicians reduce severe retinopathy of prematurity in neonates⁸ and in multiple studies, including the largest critical congenital heart disease (CCHD) study to date, to improve CCHD screening in newborns.^9-10
 
The rainbow family of advanced noninvasive measurements also allows clinicians to use the same single sensor to monitor another physiological parameter particularly important to neonatal care: methemoglobin, using SpMet. SpMet helps clinicians noninvasively and continuously monitor methemoglobin levels in the blood.¹¹ In neonates and infants, inhaled nitric oxide (iNO) therapy and even topical anesthetics containing benzocaine or prilocaine can cause elevated levels of methemoglobin.^12-13
 
Joe Kiani, Founder and CEO of Masimo, said, “We are thrilled to be able to bring the power of noninvasive hemoglobin monitoring with SpHb to the youngest, most fragile patients of all. We have long been dedicated to helping improve the lives of neonatal and infant patients, and this latest clearance significantly furthers that mission. SpHb is already used to monitor adult patients in more than 75 countries. We look forward to witnessing the impact that SpHb will now be able to have on neonatal and infant patients.”
 
SpHb is not intended to replace laboratory blood testing. Clinical decisions regarding red blood cell transfusions should be based on the clinician’s judgment considering among other factors: patient condition, continuous SpHb monitoring, and laboratory diagnostic tests using blood samples.
 
Noninvasive, continuous SpHb has received FDA clearance for patients >3 kg but is not currently indicated for patients <3 kg in the US.
 
References
¹ Ehrenfeld JM et al. Continuous Non-invasive Hemoglobin Monitoring during Orthopedic Surgery: A Randomized Trial. J Blood Disorders Transf. 2014. 5:9. 2.
² Awada WN et al. Continuous and noninvasive hemoglobin monitoring reduces red blood cell transfusion during neurosurgery: a prospective cohort study. J Clin Monit Comput. 2015 Feb 4.
³ Imaizumi et al. Continuous and noninvasive hemoglobin monitoring may reduce excessive intraoperative RBC transfusion. Proceedings from the 16th World Congress of Anaesthesiologists, Hong Kong. Abstract #PR607.
⁴ Kamal AM et al. The Value of Continuous Noninvasive Hemoglobin Monitoring in Intraoperative Blood Transfusion Practice During Abdominal Cancer Surgery. Open J Anesth. 2016;13-19.
⁵ Nathan N et al. Impact of Continuous Perioperative SpHb Monitoring. Proceedings from the 2016 ASA Annual Meeting, Chicago. Abstract #A1103.
⁶ Ribed-Sánchez B et al. Economic Analysis of the Reduction of Blood Transfusions during Surgical Procedures While Continuous Hemoglobin Monitoring is Used. Sensors. 2018, 18, 1367; doi:10.3390/s18051367.
⁷ Published clinical studies on pulse oximetry and the benefits of Masimo SET can be found on http://www.masimo.com. Comparative studies include independent and objective studies which are comprised of abstracts presented at scientific meetings and peer-reviewed journal articles.
⁸ Castillo A 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.
⁹ 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;Jan 8;338.
¹⁰ 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.
¹¹ Annabi EH et al. Anesth Analg. 2009 Mar;108(3):898-9.
¹² Riou Y et al. Pediatric Research. 1998. 43, 295-295.
¹³ U.S. Food & Drug, Consumer Updates, Benzocaine and Babies: Not a Good Mix.