Thursday, September 30, 2010

Deaths prompt CPSC, FDA warning on infant sleep positioners


WASHINGTON, D.C. - The U.S. Consumer Product Safety Commission (CPSC) and the U.S. Food and Drug Administration (FDA) today warned consumers to stop using infant sleep positioners. Over the past 13 years, CPSC and the FDA have received 12 reports of infants between the ages of 1 month and 4 four months who died when they suffocated in sleep positioners or became trapped and suffocated between a sleep positioner and the side of a crib or bassinet.

Most of the infants suffocated after rolling from a side to stomach position. In addition to the reported deaths, CPSC has received dozens of reports of infants who were placed on their backs or sides in sleep positioners, only to be found later in potentially hazardous positions within or next to the sleep positioners.

“The deaths and dangerous situations resulting from the use of infant sleep positioners are a serious concern to CPSC,” said CPSC Chairman Inez Tenenbaum. “We urge parents and caregivers to take our warning seriously and stop using these sleep positioners, so that children can have a safer sleep.”

The two main types of infant sleep positioners are flat mats with side bolsters or inclined (wedge) mats with side bolsters.


Both types of sleep positioners typically claim to help keep infants on their backs and reduce the risk of Sudden Infant Death Syndrome (SIDS). The FDA has never cleared an infant sleep positioner to prevent or reduce the risk of SIDS. In addition, CPSC and the FDA are unaware of any scientific studies demonstrating that infant positioners prevent SIDS or are proven to prevent suffocation or other life-threatening harm.

“To date, there is no scientifically sound evidence that infant sleep positioners prevent SIDS,” said Dr. Joshua Sharfstein, FDA Principal Deputy Commissioner and a pediatrician. “We want to make sure parents, health care professionals, and childcare providers understand the potential risk of suffocation and stop using infant sleep positioners.”

Sleep positioners also typically claim to do one or all of the following: aid in food digestion to ease colic or the symptoms of gastroesophageal reflux disease (GERD); and prevent flat head syndrome (plagiocephaly). In light of the new safety data, FDA believes any benefit from using these devices to ease GERD or prevent plagiocephaly is outweighed by the risk of suffocation.

CPSC and the FDA are warning parents and child care providers to:

STOP using sleep positioners. Using a positioner to hold an infant on his or her back or side for sleep is dangerous and unnecessary.
NEVER put pillows, infant sleep positioners, comforters, or quilts under a baby or in a crib.
ALWAYS place an infant on his or her back at night and during nap time. To reduce the risk of SIDS, the American Academy of Pediatrics recommends placing infants to sleep on their backs and not their sides.
The American Academy of Pediatrics does not support the use of any sleep positioner to prevent SIDS.

Manufacturers of infant sleep positioners with medical claims that have not been reviewed by the FDA should stop marketing those products until they submit, and the FDA clears, appropriate premarket review submissions, including necessary safety and effectiveness data.

FDA has informed manufacturers of cleared devices of the agency's serious concern and has requested that they submit clinical data showing the benefits of their products outweigh the risk of suffocation or other serious harm.

Prompt reporting of adverse events can help the FDA and CPSC identify and better understand the risks associated with infant sleep positioners. If you have had a problem with an infant sleep positioner, the agencies encourage you to file a report through FDA’s MedWatch program, at http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm

CPSC is interested in receiving incident or injury reports related to these products. Please visit https://www.cpsc.gov/cgibin/incident.aspx to file a report.

For more information:

CPSC: Consumer Blog http://www.cpsc.gov/onsafety/2010/09/sleep-positioners-a-suffocation-risk/

FDA: Infant Sleep Positioners Pose Suffocation Risk (Consumer article) http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm227575.htm

FDA: Infant Positioner Initial Communication http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm227301.htm

FDA: Letter to Manufacturers Concerning Medical Claims About Infant Sleep Positioners http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm227302.htm

FDA: Letter to Manufacturers of 510(k)-cleared Infant Positioners http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm227303.htm

NIH: Back to Sleep Campaign http://www.nichd.nih.gov/publications/pubs/safe_sleep_gen.cfm

NIH: Preventing Sudden Infant Death Syndrome and Suffocation www.nichd.nih.gov/health/topics/Sudden_Infant_Death_Syndrome.cfm

AAP: Policy Statement on SIDS http://aappolicy.aappublications.org/cgi/content/full/pediatrics;116/5/1245

Wednesday, September 29, 2010

State of Indiana Gives Parents More Ways to Locate and Recognize High Quality Child Care

Press Release
FOR IMMEDIATE RELEASE

Contact: Mindy Bennett at Child Care Answers
Phone: 317-636-5727 x 224
Date/Time: September 28, 2010

Paths to QUALITY™, Indiana’s voluntary quality rating and improvement system for child care programs will launch a sign campaign on October 5th designed to provide families with a new tool for recognizing high quality child care.

Child Care Answers will be hosting a Press Conference, with ten other simultaneous press conferences throughout the state on October 5th, 2010 at 10:00 am EST. The local press conference will be held at United Way of Central Indiana Conference Room D: 3901 N. Meridian Street, Indianapolis IN 46208. Exciting news will be announced by Mindy Bennett, Director of Programs and Carrie Ryland owner and operator of Better Beginnings.

Mindy Bennett of Child Care Answers states, “The signs and banners will be revealed at eligible child care programs as part of a single-day, statewide effort. We recognize how essential high quality child care is to our community. Research shows that high quality early learning experiences prepare children for future success in school, work and life. Paths to QUALITY™ is a free resource for families to use when choosing child care. The signs will immediately identify providers enrolled in Paths to QUALITY™ that provide high quality child care.”

According to Melanie Brizzi, Child Care Administrator for the Indiana Bureau of Child Care, “Over 1,900 child care programs have demonstrated their commitment to quality child care by participating in Paths to QUALITY™. The signs are a great way to recognize the efforts of programs rated at Levels 2, 3, or 4 and to tell others that these child care programs are working to give children the rich environments they deserve.”

Learn more about Paths to QUALITY™ and other child care resources in our community by contacting Child Care Answers at 317-631-4643 or www.childcareanswers.com.

To access a free, online search for a Paths to QUALITY ™ child care program, visit childcareindiana.org.
-End-

Tuesday, September 28, 2010

Additional Safe Sleep Class

We have added an additional Safe Sleep class in Indianapolis for Wednesday October 13th from 6pm-8:30pm. Contact Rae at (317) 636-5727 ext. 248.