248165 Federal Pediatric Initiatives on Infant Positioners: Practicing, Promoting, and Supporting a Safe Sleep Environment

Tuesday, November 1, 2011

Victoria Wagman, MA , Center for Devices and Radiological Health (CDRH), Food and Drug Administration, Silver Spring, MD
Susan Cummins, MD, MPH , Center for Devices and Radiological Health (CDRH), Food and Drug Administration, Silver Spring, MD
Gail Gantt, RN , Center for Devices and Radiological Health (CDRH), Food and Drug Administration, Silver Spring, MD
Joy Samuels-Reid, MD , Center for Devices and Radiological Health (CDRH), Food and Drug Administration, Silver Spring, MD
Brenda Lawrence, MD , Center for Devices and Radiological Health (CDRH), Food and Drug Administration, Silver Spring, MD
Michelle Gillice, JD , Children's Safe Sleep Team, U.S. Consumer Product Safety Commission, Bethesda, MD
Infant sleep positioners are devices intended to keep a baby in a desired position while sleeping. Those sleep positioners with medical claims are regulated by the FDA; all others are regulated by CPSC. This presentation will: review twelve infant deaths associated with use of infant sleep positioners that were reported to the Consumer Product Safety Commission (CPSC) from 1997 to 2010; the regulatory history of these devices; and recent actions taken by CPSC and the Food and Drug Administration (FDA) to limit sale and use of these products. As a result of these deaths, FDA and CPSC issued a joint news release to describe the suffocation and entrapment risk infant sleep positioner use and urged parents and caregivers to cease use. FDA also issued other health communications about the hazards of infant sleep positioners, asked manufacturers of infant sleep positioners with medical claims to cease marketing and submit data demonstrating that the benefit of this device outweighed risk of suffocation. The close collaboration between FDA and CPSC allowed each agency to benefit from the strengths of the other and thus optimize the overall effectiveness of this educational and regulatory public health effort. This effort to limit and prevent the use of infant sleep positioners align with longstanding efforts by the Department of Health and Human Services, CPSC and many other organizations to create a safe sleep environment for infants to prevent SIDS and SUID

Learning Areas:
Public health or related laws, regulations, standards, or guidelines
Public health or related public policy

Learning Objectives:
Participants will understand the risks of infant sleep positioners Participants will understand the joint roles of FDA and CPSC in regulating these medical or consumer products Participants will understand how FDA and CPSC leveraged each agency’s resources to optimize the reach and effectiveness of its work to limit and prevent use of infant sleep positioners Participants will understand how efforts to limit and prevent use of infant sleep positioners align with longstanding efforts to create a safe sleep environment for infants to prevent SIDS and SUID.

Keywords: SIDS, Maternal and Child Health

Presenting author's disclosure statement:

Qualified on the content I am responsible for because: I am qualified to present because I work in the Office of the Center Director and work on General Hospital issues which covers pediatric devices
Any relevant financial relationships? No

I agree to comply with the American Public Health Association Conflict of Interest and Commercial Support Guidelines, and to disclose to the participants any off-label or experimental uses of a commercial product or service discussed in my presentation.

See more of: Infant and Child Health, Infant Mortality and SIDS Poster Session
See more of: Maternal and Child Health