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U.S. Health & Human Services Makes Critical Congenital Heart Defect Screening Using Motion-Tolerant Pulse Oximetry a Nationwide Newborn Screening Standard
Date:9/23/2011

by pulse oximetry for all newborns into federal Recommended Uniform Screening Panel (RUSP) Guidelines—the national newborn screening system standards and policies.  Citing the "emerging evidence base for the utility of early diagnosis and detection of CCHD via measurement of blood oxygen saturation" and the "momentum and commitment" at the state and federal levels, Sebelius directed federal agencies to "proceed expeditiously with implementation." The federal Agency Plan of Action outlined by HHS calls for the National Institutes of Health (NIH) to fund technology, process, care, and outcomes research activities; the Centers for Disease Control and Prevention (CDC) to fund surveillance activities to monitor infant morbidity and mortality outcomes; and the Health Resources and Services Administration (HRSA) to guide development of screening standards and implementation infrastructure, including training materials.(3)

In August 2011, a panel of pediatric and cardiac experts from the American Academy of Pediatrics (AAP), the American College of Cardiology (ACC), and the American Heart Association (AHA), in conjunction with the HHS Secretary's Advisory Committee on Heritable Disorders in Newborns and Children (SACHDNC), acted on the HHS 2010 recommendation(6) and outlined a strategy for routine screening of newborns to improve detection of CHD.(7)  The 28-page report recommends that newborn screening be done with "motion-tolerant pulse oximeters that report functional oxygen saturation, have been validated in low perfusion conditions, have been cleared by the FDA for use in newborns, and have a 2% root-mean-square accuracy."  The report also outlined a 5-point implementation strategy and follow-up procedures, which includes screening, diagnostic confirmation, electronic results reporting, primary care follow-up, surveillance and tracking.

Gerard R. Martin, M.D., F.A.A.P., F.A.C.C., Senior Vice President of the Center for Heart, Lung an
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SOURCE Masimo Corporation
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