The American Academy of Pediatrics recommends that infants be placed on their backs to sleep to reduce the risk of SIDS. Sleep positioners that do not meet the definition of a medical device may be regulated by the Consumer Product Safety Commission. 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). Many manufacturers claim that their products can also reduce the risk of sudden infant death syndrome (SIDS), although the FDA has not approved any devices for this indication. Following an FDA inspection of Owlets marketing materials, which raised serious safety concerns, the agency has issued a warning letter to the company. The sleep sack is intended to make the baby feel secure and held, which can help to calm them down. ALWAYS place a baby on his or her back at night and during nap . Now this is some infrastructure and support that will make sure that [parents can make purchases] in a more rigorous fashion, that there are criteria to be met. Each year, about 4,000 infants die unexpectedly during sleep time from accidental suffocation, SIDS, or unknown causes, according to the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The FDA's Sharfstein said the agency has never approved a sleep position to prevent SIDS. Soft, Flame-retardant NICU Infant ID Bracelets (patent pending) - gentle on newborn and preemie skin. The novelty of rolling over in the crib fades as soon as it begins. Most parents want to do everything they can to ensure a good nights sleep for their baby and themselves. The majority of babies can use a sleep sack until they reach the age of two. If you are using a sleep sack for the first time, it is a good idea to ask your pediatrician for advice. 4 To help clear up this confusion, Dr. Johns explains that some infants with a medical history may require sleep support only if it is something that has been prearranged with the child's pediatric specialist. The FDA is warning parents and other caregivers not to use infant sleep positioners because the baby may die from suffocation. doi:10.1542/peds.2020-035873. WebMD does not provide medical advice, diagnosis or treatment. As a result, Smart Socks are not subject to the same medical and safety standards as other types of medical devices because they have not been approved by the FDA. Babies require a lot of sleep, and according to the American Academy of Pediatrics, babies should sleep in a crib, bassinet, or cradle in a semi-upright position with their head slightly off the end and their arms and legs hanging down. If you are considering using a side wedge for your baby, it is important to talk to your doctor or another medical professional to get their opinion. Fda Approved Infant Sleep Positioner. Do pediatrician recommend sleep sacks for infants? When you sleep on your back, you are less likely to develop SIDS (Sudden Infant Death Syndrome). Click Here to request a login to purchase online. Christina Johns, MD, pediatrician and medical senior advisor at PM Pediatrics says, Have I seen tragedies within my career? If you have a young child, placing him or her on the stomach or side is not recommended. The CPSC advises that infants sleep in a crib, bassinet, or cradle in a semi-upright position with their heads slightly off the end and their arms and legs hanging down. According to the National Database of Nursing Quality Indicators (2016, pp. In addition to reports about deaths, the federal government also has received reports about babies who were placed on their backs or sides in positionersbut were later found in other, dangerous positions within or next to these products. Our website is not intended to be a substitute for professional medical advice, diagnosis, or treatment. In addition to infant sleep positioners, we are concerned about pillows, soft, fluffy and shaggy blankets, comforters, and mattress covers, and other products that can cover a child's nostrils or interfere with an infant's breathing. Keep in mind that this should not be done until the child is at least one year old; in accordance with the AAPs safe sleep guidelines, this should not begin until that time. WebMD does not provide medical advice, diagnosis or treatment. fda approved infant sleep positioner. Up until now, the safety of many infant sleep products was determined only by the manufacturer. If you want to keep your baby safe, place a swaddle blanket or a sleeper on their back. The link you selected is for a destination outside of the Federal Government. These productssometimes also called nests or anti-roll productscan cause suffocation (a struggle to breathe) that can lead to death. Create a support network of friends, family, and professional help where you can. Thank you, {{form.email}}, for signing up. Ali is a Registered Nurse/Midwife with 12 years of experience, and a freelance health writer who is passionate about helping people understand their own health journey. Inclined sleep surfaces should be no greater than 10 degrees. Most of the infants suffocated after rolling from a side to stomach position. By clicking Subscribe, I agree to the WebMD, Smart Grocery Shopping When You Have Diabetes, Surprising Things You Didn't Know About Dogs and Cats, Bird Flu Deaths Prompt U.S. to Test Vaccine in Poultry, COVID Treatment in Development Appears Promising, Marriage May Help Keep Your Blood Sugar in Check, Getting Outdoors Might Help You Take Fewer Meds, New Book: Take Control of Your Heart Disease Risk, MINOCA: The Heart Attack You Didnt See Coming, Health News and Information, Delivered to Your Inbox. CPSC chairman Inez Tenenbaum said the warning against infant sleep positioners is one component of the agency's Safe Sleep Initiative. FDA said in a Safety Alert issued Tuesday that it has . One is a flat mat with a side bolster. The warmth and comfort of a sleep sack can be provided by providing a blanket without the risk of sliding on it. Sharfstein said the agency has not heard back from all of the device makers, but expects all of them to comply with the demands. The site is secure. The FDA regulates baby products as medical devices if, among other things, the manufacturer claims that the product is intended to cure, mitigate, treat, or prevent, or reduce a disease or condition in its labeling, packaging, or advertising. This device gives nurses a vital tool in their daily role of repositioning and caring for these special preemies. 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. An analysis found that infant sleep sacks are as safe as, if not safer than, other bedding for preventing SIDS. They are largely parents who are exhausted and desperate and trying to figure out a way for them to settle down a colicky baby so that they can rest themselves.. The sleep positioners are intended to keep a baby in a desired position while sleeping Using a device to hold an infant in a particular position poses a serious suffocation risk and is unnecessary. 18 0 obj << /Filter /FlateDecode /Length 19 0 R >> stream The patented, FDA Approved Nurture Rest neonatal positioning device was designed by a neonatal nurse, to be used by neonatal nurses and the preemies that they care for daily. MNfGtGDvGfGAqAb%"%+&PgIpE8`s$CF:/y:#8eGD! Using this type of product to hold an infant on his or her side or back is dangerous and unnecessary. You want your child to be mobile. * This document was prepared by CPSC staff, has not been reviewed or approved by, and may not necessarily reflect the views of the Commission. This device gives nurses a vital tool in their daily . Infant sleep positioners that are used to keep babies on their backs and protect them from sudden infant death syndrome have led 12 children to suffocate in the past 13 years and should no. Four of the 13 infants also had recent respiratory symptoms, such as a cold. The advisory was prompted by reports of 12 deaths among infants from 1 to 4 months of age received by the CPSC over the past 13 years, in addition to dozens of additional nonfatal cases in which babies awoke in unsafe positions after being placed in a sleep positioner. You can do your part to keep your baby safe by not using sleep positioners. This is some infrastructure and support that will make sure that [parents can make purchases] in a more rigorous fashion, that there are criteria to be met. Appropriate clothing keeps babies warm enough while they are sleeping. Always put babies on their backs to sleep. The FDA may follow up with enforcement actions or recall specific products in the future, Sharfstein said, adding that a warning was considered the fastest way to convey the message about the dangers of infant sleep positioners to the public. However, it is important to make sure that the sleep sack is the appropriate size for your child, and that they are not able to wriggle out of it. According to the FDA announcement, parents should: STOP using infant positioning products. Always check with your health care professional before using any new medical product for your baby. Several companies market products that help to alleviate the symptoms of gastroesophageal reflux disease (GERD). Following a review of marketing materials, the FDA determined that Smart Socks were marketed to parents as a way to monitor their childrens health, but they did not have the FDAs approval. Four of the infants had been born prematurely and three were one of a set of twins. B. Because of our plans to submit a device application to the FDA, we have decided that the Smart Sock will no longer be available in the United States. The FDA has never approved any infant sleep positioner to prevent or reduce the risk of SIDS. The FDA suggests to parents, nannies, and other caregivers not to put babies in sleep positioners, also referred to as "nests" or "anti-roll" products. What Happens When Your Son Is Circumcised? If you are human user receiving this message, we can add your IP address to a set of IPs that can access FederalRegister.gov & eCFR.gov; complete the CAPTCHA (bot test) below and click "Request Access". You may wish to review the privacy policy of the external site as its information collection practices may differ from ours. This type of pillow can be placed under the babys back or behind their head to help keep them from rolling over. Phone: (301) 504-7908 Some experts say that they are fine as long as they are used properly, while others believe that they can be dangerous. The FDA has approved 18 infant sleep positioners since the early 1980s because of some evidence that the devices ease the symptoms of gastroesophageal reflux disease (GERD) and prevent flattening of one side of the skull, but many more than 18 such products are available on the market, according to Dr. Joshua Sharfstein, principal deputy commissioner of the FDA.