Although newborn screening for critical congenital heart disease (CCHD) was recommended by the US Health and Human Services Secretary's Advisory Committee on Heritable Disorders in Newborns and Children to promote early detection, it was deemed by the Secretary of the HHS as not ready for adoption pending an implementation plan from HHS agencies.
To develop strategies for the implementation of safe, effective, and efficient screening.
A work group was convened with members selected by the Secretary's Advisory Committee on Heritable Disorders in Newborns and Children, the American Academy of Pediatrics, the American College of Cardiology Foundation, and the American Heart Association.
On the basis of published and unpublished data, the work group made recommendations for a standardized approach to screening and diagnostic follow-up. Key issues for future research and evaluation were identified.
The work-group members found sufficient evidence to begin screening for low blood oxygen saturation through the use of pulse-oximetry monitoring to detect CCHD in well-infant and intermediate care nurseries. Research is needed regarding screening in special populations (eg, at high altitude) and to evaluate service infrastructure and delivery strategies (eg, telemedicine) for nurseries without on-site echocardiography. Public health agencies will have an important role in quality assurance and surveillance. Central to the effectiveness of screening will be the development of a national technical assistance center to coordinate implementation and evaluation of newborn screening for CCHD.
Comments
Do technology recommendations impede implementing screening?
To the EDITOR,
We commend the authors and workgroup for the effort in developing "Strategies for Implementing Screening for Congenital Heart Disease,"1 as a roadmap to facilitate the initiation of screening programs. Although we fully support implementation of these programs, we are concerned that the specific technology recommendations put unnecessary burdens on hospitals that will delay routine screening. Specifically, the work group recommendation: "that screening be performed with motion tolerant pulse oximeters2 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" creates particular challenges because of the specification for motion tolerant pulse oximeters. This recommendation is concerning because motion tolerance specifications are currently not in any of the standards3 or regulatory requirements4 for pulse oximetry devices. Although manufacturers may test for motion tolerance, there is no scientific method to compare motion testing applied to different devices. The reference cited in the recommendations does not include a ratified standard2.
In the clinical studies cited in the document, nearly half were conducted without requiring motion tolerant pulse oximeters. If strictly interpreted, only a few pulse oximeter systems can fulfill these recommendations, and there is no evidence to suggest that these specifications are required to conduct effective screening. The current recommendations, if adopted or legislated, may cause additional undue burden on hospitals and/or delays if new equipment must be acquired to implement routine screening.
We therefore suggest that the workgroup revise the screening technology recommendation to read: "pulse oximeters that report functional saturation with a 2% root-mean-square accuracy (Arms), have been validated in low-perfusion conditions, and have been cleared by the FDA for use in newborns". This recommendation would be in concordance with current published standards and regulatory requirements, and would enable effective technology already broadly available to conduct screening.
Scott D. Kelley, MD Chief Medical Officer Respiratory & Monitoring Solutions Covidien Boulder, Colorado
Tricia C. Stewart, PA-C, MS Therapy Area Manager
Ulf Borg Director, Clinical Affairs
REFERENCES
1. Kemper AR, Mahle WT, Martin GR, et al. Strategies for Implementing Screening for Critical Congenital Heart Disease. Pediatrics 2011;128:e1259 -e1267 2. Clinical and Laboratory Standards Institute. Pulse Oximetry; Approved Guideline. 2nd ed. CLSI document POCT11-A2. Wayne, PA: Clinical and Laboratory Standards Institute; 2011 3. International Standards Organization. ISO 80601-2-61 Ed.1: Medical electrical equipment - Part 2-61: Particular requirements for the basic safety and essential performance of pulse oximeters equipment for medical use. 2011. 4. Food and Drug Administration. Draft Guidance for Industry and FDA Staff: Pulse Oximeters - Premarket Notification Submissions [510(k)s]. 2007.
Conflict of Interest:
The authors are employees of Covidien, a manufacturer of pulse oximetry monitorings systems
Routine Pulse Oximetry Screen of Newborns
To the Editor:
The authors of the article, "Strategies for Implementing Screening for Critical Congenital Heart Disease,"1 should be commended for putting forth a thoughtful, clear, and considerate strategy to enhance early detection of critical congenital heart disease (CCHD), a major cause of infant morbidity and mortality. The suggested strategy provides a thorough outline for the implementation of routine pulse oximetry testing as an adjunct to the newborn examination. Routine pulse oximetry testing is underway in a number of states, and some states have passed related legislation. For example, our neighboring state, New Jersey, was the first state to pass legislation requiring hospitals to screen all newborns with pulse oximetry testing (New Jersey Bill A3744). In other states, such as Pennsylvania, legislation is currently under consideration. With endorsement from the AAP, ACCF and the AHA combined with previous endorsement by the SACHDNC in 2010, even more states and nurseries will begin to implement pulse-oximetry protocols.
With all the excitement around the use of pulse oximetry as a screening tool for CCHD, we must bear in mind several limitations. Firstly, the technology has proven to be highly specific but has continually demonstrated a low sensitivity for detection of CCHD, ranging from 60%-78%.2-4 Secondly, the recommendations include screening of infants between 24 - 48 hours of life, the window of time when nurseries are conducting a substantial number of other essential assessments prior to discharge, including but not limited to newborn hearing screening, assessments for jaundice, education about safe sleep, and car seat safety inspections. Thirdly, pulse oximetry testing will need to be carried out by trained nurses or ancillary staff to maintain its quality and efficiency. This may add to the burden of costs that hospitals already have in the care of the normal newborn, which is in the majority of cases is reimbursed under an all-encompassing DRG.
Pulse oximetry screening in newborns is an easy test that will enhance our ability to detect CCHD, and the limitations above need to be addressed by hospitals, the communities they serve, and policy makers. We support adoption of the proposed pulse oximetry monitoring protocol in Figure 1.1 Furthermore, we agree with the recommendation that various related organizations work with the AMA to implement CPT coding for pulse oximetry screening, so as to not to create further un- and under-funded mandates, examples of which include poor Medicaid reimbursement for vaccine administration5 and the lack of equitable reimbursement for EPSDT.
Kevin A. Lawson, BS, Third-Year Medical Student Jefferson Medical College Philadelphia, PA 19107
and
Esther K. Chung, MD, MPH, FAAP Department of Pediatrics Jefferson Medical College Philadelphia, PA 19107
Department of Pediatrics Alfred I. duPont Hospital for Children Wilmington, DE 19803
REFERENCES
1. Kemper AR, Mahle WT, Martin GR, et al. Strategies for Implementing Screening for Critical Congenital Heart Disease. Pediatrics 2011 [epub ahead of print].
2. Ewer AK, Middleton LJ, Furmston AT, et al. Pulse oximetry screening for congenital heart defects in newborn infants (PulseOx): a test accuracy study. Lancet 2011;378:785-794.
3. Koppel RI, Druschel CM, Carter T, et al. Effectiveness of pulse oximetry screening for congenital heart disease in asymptomatic newborns. Pediatrics 2003;111:451-455.
4. Riede FT, Worner C, Dahnert I, Mockel A, Kostelka M, Schneider P. Effectiveness of neonatal pulse oximetry screening for detection of critical congenital heart disease in daily clinical routine--results from a prospective multicenter study. Eur J Pediatr 2010;169:975-981.
5. Bednarczyk RA, Birkhead GS. Reducing financial barriers to vaccinating children and adolescents in the USA. Curr Opin Pediatr 2011;23:105-109.
Conflict of Interest:
None declared