In September 2011, the United States Department of Health and Human Services (HHS) approved adding screening newborns for critical congenital heart defects (CCHDs) with pulse oximetry to the Recommended Uniform Screening Panel.
Screening should be performed with pulse oximeters that are motion tolerant, report functional oxygen saturation, have been validated in low perfusion conditions, have been cleared by the FDA for use in newborns and have an accuracy of +/-2 digits.([FOOTNOTE=Kemper AR, Mahle WT, Martin GR et al. Strategies for implementing screening for critical congenital heart disease. Pediatrics. 2011;128(5):e1259-1267.],[ANCHOR=],[LINK=])
In the United States, about 4,800 (or 11.6 per 10,000) babies are born every year with CCHDs. These babies are at significant risk if this condition goes undiagnosed.([FOOTNOTE=Centers for Disease Control and Prevention. Pulse Oximetry Screening for Critical Congenital Heart Defects. Available at: http://www.cdc.gov/ncbddd/pediatricgenetics/CCHDscreening.html.],[ANCHOR=],[LINK=])
We offer the most accurate pulse oximetry technology that meets all of these recommendations.
In support of the HHS guidelines, we are offering education materials and training to enable you to more efficiently comply.
Our Nellcor™ pulse oximetry portfolio facilitates quick, noninvasive screenings for CCHD. The products are U.S. Food and Drug Administration (FDA)-510(k) cleared for use on neonates, have been labeled as a tool to aid in CCHD screenings, and are motion tolerant, so you can confidently rely on them for accurate CCHD screenings.
Additionally, since 1993, Nellcor™ pulse oximetry technology has been utilized on more than 33,000 newborns spanning five separate clinical studies evaluating the use of pulse oximetry for critical congenital heart disease screening.
Nellcor™ pulse oximetry technology specifies highly accurate readings in neonates, largely because it relies on cardiac-based signals to generate readings closely tied to the patient’s physiology. The result is consistent performance during a number of challenging conditions, including patient motion, noise and low perfusion, all of which can impede the assessment of patient respiratory status.
Using Nellcor™ pulse oximetry has been shown to be a simple and economical tool to aid healthcare providers in CCHD screening.