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Masimo Continues Its Advocacy on Behalf of Newborns During Congenital Heart Defects (CHD) Awareness Week
Date:2/15/2013

Centers for Disease Control and Prevention.  

Recognizing the growing need for universal CCHD screening and the "emerging evidence base for the utility of early diagnosis and detection of CCHD via measurement of blood oxygen saturation," the U.S. Department of Health and Human Services (HHS) made CCHD screening by pulse oximetry a nationwide standard by adding it to the Recommended Uniform Screening Panel (RUSP) Guidelines in 2011. Federal guidelines recommend pulse oximetry screening with "motion-tolerant pulse oximeters" that "have been validated in low perfusion conditions."5

To effectively screen for CCHD, using the right technology matters. Last year Masimo received FDA 510(k) clearance for SET® pulse oximeters, rainbow® Pulse CO-Oximeters®, and neonatal sensors with labeling for screening newborns for CCHD. This marked the first time the FDA cleared specific labeling indicating the use of pulse oximeters, in conjunction with a physical exam, to screen newborns for CCHD.

Validation of SET®'s advantage for CCHD screening is provided in a 2005 study by Dr. Anne de Wahl Granelli that evaluated the sensitivity of various SpO2 cut points for CCHD screening.  In the study, Dr. Granelli evaluated a SET® and non-SET pulse oximeter which has been referred to as "next generation" technology (GE Ohmeda Tuffsat).6 The "next generation" technology resulted in 41% of post-ductal SpO2 values below 95%, while the SET® pulse oximeter recorded only 1%.7 The high number of false positives with non-SET pulse oximetry led Dr. Granelli to abandon use of it and focus exclusively on signal extraction technology with SET® pulse oximeters for future CCHD studies. This result is not surprising, given that CCHD screening is often performed during motion and low perfusion.&#
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