July 10, 2012
In 2011 the U.S. Department of Health and Human Services Secretary Kathleen Sebelius approved adding CCHD (critical congenital heart disease) screening to the Recommended Uniform Screening Panel. A number of states have now passed legislation requiring newborns to have pulse oximetry screening to detect critical congenital heart defects. According to the CDC (Center for Disease Control and Prevention), “in the context of newborn screening using pulse oximetry, seven defects are classified as CCHD: Hypoplastic left heart syndrome; Pulmonary atresia (with intact septum); Tetralogy of fallot; Total Anomalous pulmonary venous return; Transposition of the great arteries; Tricuspid atreasia; and Truncus arteriosus.” Which means, in the United States, about 4,800 babies are born each year with CCHDs.
Hospitals across the nation have started implementing this screening process. Requirements for screening are different in each state, so be sure to check your particular state guidelines. The CDC offers a status map on their website at www.cchdscreeningmap.com.
Since pulse oximetry is used to measure the amount of oxygen in the blood, it is the recommended screening method for detecting CCHDs. Some of the equipment requirements include:
• Must be validated in low-perfusion conditions
• Must have been cleared by the FDA for use in newborns
• Must be motion-tolerant and report functional oxygen saturation
• Must be calibrated regularly based on manufacturer guidelines
The MD Buyline database includes a wide variety of pulse oximetry products. The highest purchasing activity is with Massimo and Nellcor (Covidien). Pulse oximetry monitors range from $1,800 to $3,000 depending on the model configuration. In addition to the pulse oximetry equipment, there are the associated supplies to consider. Reusable sensors range from $140 to $160 each. The Buyline Consumable database reflects prices starting at $9.50 each for disposable sensors.