HEART Program

Help Ensure Access to the Right Technology for CCHD Screening

In September 2011, the U.S. Department of Health and Human Services (HHS) added pulse oximetry screening for critical congenital heart disease (CCHD) to the Recommended Uniform Screening Panel for newborns. Since that time, multiple states have implemented additional requirements for hospitals to screen all newborns.

HHS took this action based on the published findings of the CCHD Workgroup,1 which relied on two major independent, published, prospective clinical studies that exclusively used Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximeters to recommend screening with "motion-tolerant pulse oximeters" that "have been validated in low perfusion conditions".

Masimo SET® pulse oximeters and sensors have previously been cleared to measure oxygen saturation and pulse rate during motion and low perfusion conditions in newborns, but in September 2012 Masimo received FDA 510(k) clearance for labeling indicating the use of its pulse oximeters, in conjunction with a physical exam, to screen newborns for CCHD.

In spite of the wide availability of Masimo SET® pulse oximetry, both as standalone products as well as integrated products in over 100 multiparameter monitors from over 50 brands, some hospitals still do not have Masimo SET® technology. Given the strong evidence supporting the use of Masimo SET® pulse oximetry for CCHD screening and Masimo's commitment to help save and improve babies' lives through expanded CCHD screening programs, the company announced the HEART Program (Help Ensure Access to the Right Technology for CCHD Screening). The program 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 if you purchase a Sensor Start Kit.

Newborn CCHD Screening: Step-by-Step Instructional Guide

Program Details

  • > Please complete the questions below related to your current practice, declared need for a free pulse oximeter and contact information.
  • > You will receive a confirmation email verifying receipt of your request.
  • > A Masimo representative will contact you within a few business days to verify necessary information.
  • > If the hospital is approved, a Masimo Rad-5® Pulse Oximeter with Masimo SET® technology will be provided to the hospital at no charge.
  • > Hospitals must purchase all cables and sensors for use with the Masimo SET® pulse oximeter (as they would need to do with any non-Masimo SET® pulse oximeter). Details, technical specifications and pricing to be provided by Masimo to hospital.
  • > There is no specific expiration date for this program, but Masimo has to right to end the program at any time.

Eligibility

  • > Hospitals, Medical Centers that do not have access to Masimo SET® pulse oximeter to use for CCHD screening
  • > Hospital, Medical Centers that do not have funds to purchase a Masimo SET® pulse oximeter for CCHD screening
  • > Hospitals, Medical Centers must be located in countries where Masimo has an office and/or operations: Australia, Canada, China, France, Germany, Italy, Japan, Singapore, Spain, United Kingdom, United States.
  • 1 Alex R. Kemper, William T. Mahle, Gerard R. Martin, W. Carl Cooley, Praveen Kumar, W. Robert Morrow, Kellie Kelm, Gail D. Pearson, Jill Glidewell, Scott D. Grosse, R. Rodney Howell. “Strategies for Implementing Screening for Critical Congenital Heart Disease.” Pediatrics; Volume 128, No. 5; November 2011; e1-w10 DOI: 10.1542/peds.2011-1317. Available here