Regarding the Sept. 29/10 FDA warning on infant sleep positioners:

This warning does not apply to hospitals where infants are in a highly monitored setting! The RES-Q Wedge is registered with the FDA as a Class 1 Medical Orthopedic Device (not a sleep positioner) used to help treat the orthopedic conditions associated with infant reflux. Due to recent FDA sleep positioner warnings, the manufacturers of the RES-Q Wedge have submitted new safety and effectiveness data as well as current medical research to support their product design. *(See below for a list of current medical studies) The FDA warning is to manufacturer’s of sleep positioners on the market that are making medical claims, but do not have clearance from the FDA as a safe medical device. Please note that the FDA has linked 2 types of sleep positioners to ‘deaths and dangerous situations’. They are positioners that are flat mats with side bolsters and inclined (wedge) mats with side bolsters. The RES-Q Wedge is not a mat and does not have side bolsters. The patented double anchored suspended RES-Q Sling design allows the infant to rest safely and securely with the help of gravity in the center of the RES-Q Wedge. If you have any further questions or concerns, please feel free to e-mail us at: resqwedge@gmail.com

*Current Medical Studies that support proper developmental orthopedic positioning for infants:

1. Arguin, A.L., and Swartz, M.K. Gastroesophageal Reflux in Infants: A Primary Care Perspective. Pediatric Nursing 2004; 30 (1)
2. Gillies, D., and Wells. Positioning for acute respiratory distress in hospitalized infants and children. Cochrane database of systemic reviews 2009 updated. Original 2005; Issue 2. Art No.: CD003645. DOI 10.1002/14651858.CD003645.pub2
3. Hunter, J. Kenner, C., and McGrath, J.M. ‘Positioning’ (eds) Develop[mental Care of Newborns and Infants; A Guide for Health Professionals 2004; St. Louis Elsevier pp 219-319
4. Kenner, C., and Lott, J.W. Comprehensive Neonatal Care: An Interdisciplinary Approach 2007 Fourth Edition. Saunders Elsevier. Missouri
5. Merenstein, G.B., & Gardner, S.L. Handbook of Neonatal Intensive Care 2002 Fifth Edition. Mosby Elsevier. Missouri
6. Perez-Woods, R., Mally, M.B, & Tse, A.M. Position and skin care of the low birth weight neonate. NAACOG’s Clinical Issues in Perinatal & Women’s Health Nursing 2002; 01 January 1992, Vol. 3/1 pp 97-113
7. Symington, A.J. and Pinelli, J. Developmental care for promoting development and preventing morbidity in preterm infants. Cochrane database of systematic reviews 2006 Issue 2. Art No.: CD001814. DOI 10.1002/14651858.CD001814.pub2
8. Tighe, M.P., & Beattie, R.M. Managing gastro-oesophageal reflux in infancy. Arch Dis Child 2010; 95: 243-244
9. Vandenplas, Y., De Schipper, J., Verheyden, S. et al. A preliminary report on the efficacy of the Multicare AR-bed in 3-week-3-month-old infants on regurgitation, associated symptoms and acid reflux. Arch Dis Child 2010; 95: 26-30
10. Ward, Dawne. Positioning of Preterm and Sick Neonates. Trent Perinatal Network 2009; 1-9