IRVINE, Calif., Feb. 15, 2013 /PRNewswire/ -- Congenital Heart Defects (CHD) are the leading cause of infant deaths – affecting about 1 in 125 babies. 1,2 In the U.S., one in three infants with a potentially life-threatening CHD leaves the hospital undiagnosed. 3
Early detection through pulse oximetry screening and intervention are keys to saving the lives of babies with CHDs. 4 The screening determines the amount of oxygen in the blood and pulse rate. It is inexpensive, noninvasive, and fast. As part of Congenital Heart Defect Awareness Week ( Feb. 7-14), Masimo (NASDAQ: MASI) continued to advocate for pulse oximetry screening of all newborns by demonstrating proper sensor placement during the America Heart Association's "Heart on the Hill Day" in St. Paul, Minn., earlier this week. Minnesota is joining a growing number of states that are enacting or have enacted legislation that require screening newborns for Critical Congenital Heart Disease (CCHD) prior to discharge from hospitals. To date, California, Connecticut, Delaware, Indiana, Maryland, New Hampshire, New Jersey, Tennessee and West Virginia have enacted such legislation, according to the Newborn Coalition.
Although screening newborns with Measure-Through Motion and Low Perfusion Masimo SET ® pulse oximetry has been shown to increase CCHD detection by 34%, 4 CCHD screening is not currently included in most state newborn screening panels, according to the 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." 5To 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. To ensure that hospitals have the right technology in place to perform CCHD screening on newborns, Masimo announced the HEART Program (Help Ensure Access to the Right Technology). It enables hospitals in countries where Masimo has a presence that want to perform CCHD screening with a Masimo SET ® pulse oximeter, but do not have one and do not have funds to purchase one, to receive a free Masimo SET ® pulse oximeter. More details are available at www.masimo.com/heartprogram. Offering the HEART program internationally provides an opportunity to help solve the global CCHD burden around the world as health officials from the United Arab Emirates (UAE) to Beijing ( China) and the UK have embraced Masimo pulse oximetry screening of newborns for CCHD. "Early on Masimo SET ® technology, because of its ability to measure-through motion, was an instrumental part of the protocol that dramatically reduced neonatal eye damage and Retinopathy of Prematurity in countless newborns," said Joe Kiani, founder and CEO of Masimo. "Now we are seeing Masimo technology play an increasing role in the early detection of CCHD in newborns, which is helping save precious lives and spare families the soul-crushing pain of losing an infant. For Masimo, every week is CHD Awareness Week." To download the Action Plan to Address Failure to Detect Critical Congenital Heart Disease (CCHD) presented at this year's Patient Safety, Science & Technology Summit, please visit: http://www.patientsafetysummit.org/challenges/challenge-6-cchd-screening-in-newborn-infants.aspx Also available online, Masimo's Newborn CCHD Screening Step-by-Step Instructional Guide, which provides another helpful resource to clinicians and hospitals looking to implement CCHD screening in their institutions. Visit: http://www.masimo.com/heartprogram/documents/LAB6252B_Sales_Tool_CCHD_Screening_Adhesive_Sensor.pdf 1 National Heart, Lung and Blood Institute. Congenital Heart Defects. December 2007. 2 Congenital Cardiovascular Defects: Current Knowledge: A Scientific Statement From the American Heart Association Council on Cardiovascular Disease in the Young. Circulation, volume 115, June 12, 2007, pages 2995-3014. 3 Wren C, Reinhardt Z, Khawaja K. Twenty-year trends in diagnosis of life-threatening neonatal cardiovascular malformations. Arch Dis Child Fetal Neonatal Ed. 2008;93:F33–F35.