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Neonatal Loving Kare, Inc. Transport Roll is used for transporting infants from referring hospitals via helicopter or ambulance. Now, in a new move, the Consumer Product Safety Commission (CPSC) has set stringent federal safety standards for infant sleep products that manufacturers must meet by mid-2022. Safe baby sleep positioners are devices that are designed to keep your baby in a specific position while sleeping. A TotAha anti-flat head pillow can be used to evenly distribute pressure on the head, make the three sides of the head evenly stressed, easily shape the babys head shape, and bring some support to the neck, allowing the cervical spine to grow naturally. Knowing what your baby needs can be very confusing when youre faced with an array of products. Some babies have been found in dangerous positions next to a positioner they had been placed in for sleeping. 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. DDDH`w&p@L9B!$088">YFPFHDG!rHADDe9G":#tGD|E2CN'qE x*Hq8 eFYB#aF/;#x/,r"Cq(r9 iH#`s"h3q#tG#|B""""""""":T,s$6A""C%CTq!87"(#c#8:#vl>nH"""""""""2{$884I.Gs$c\rc:C(v[yGFm6taB"""""""#p@rH HQAz"B988r B$828R3E.#tGE"""""""#NBP91DDrcq$8C8cxaTq?hq(qBGDsPDYdp<4"c9DH{ Dhqtn.]B""""#+$!,tA"CI BX4 \rCq$D8q rr+.E98Hqjb#>GF{ For example: The rule does not include things that babies may sleep in but are not designed for sleep, such as: If your baby falls asleep in a car seat, stroller, swing, infant carrier, or sling, you should move him or her to a firm sleep surface on his or her back as soon as possible. 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. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Baby sleep positioners carry risk of suffocation and death, FDA warns. Baby sleeping bags, also known as sleep sacks, are Wearable blankets that keep your baby warm during the night. You can learn more about safe sleeping environments on NICHDs website. Transport Roll used for transporting infants from referring hospitals via helicopter or ambulance. Phone: (301) 504-7908 Available products come in a variety of colors and designs, but certain key elements are consistent in a sleep positioner: The surface incorporates a thin mat The mat has rolls on each side The item incorporates a wedge to elevate the baby's head Nestle, USA (Nestle Infant . We invite you to use the Nurture Rest positioning device. This device gives nurses a vital tool in their daily role of repositioning and caring for these special preemies. Call CPSCs Hotline at 800-638-2772 (TTY 301-595-7054). Safety standard for bassinets and cradles. A health regulator in the United States has advised parents not to use them after a dozen babies died of suffocation. 2023 Dotdash Media, Inc. All rights reserved, Verywell Family uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. The back of your baby is a good place to sleep for a variety of reasons. (This intended use can be outlined by statements made on the labels, labeling, instructions for use, or promotional materials for the products.). 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. Save my name, email, and website in this browser for the next time I comment. Deaths, injuries, and property damage from consumer product-related incidents cost the nation more than $1 trillion annually. Flat head syndrome is most commonly associated with babies who have very soft skulls before the age of six months. Food and Drug Administration. Manufacturers of infant sleep positioners with medical claims that have not been reviewed by the FDA should stop marketing those products until they submit, and the FDA clears, appropriate premarket review submissions, including necessary safety and effectiveness data. Appropriate clothing keeps babies warm enough while they are sleeping. City State Zip CFN; Abbott Laboratories (Abbott Nutrition) 300 Stelzer Road; Columbus; OH 43219-7677: N/A Mead Johnson (Mead Johnson Nutritionals) 2400 West Lloyd Expressway . Does sleep sacks have an effect on health? The FDA is aware of infant deaths from these products over the years. Any soft surface is a suffocation risk for infants. Babies require a lot of sleep, and according to the American Academy of Pediatrics, babies should sleep in a crib, bassinet, or cradle in a semi-upright position with their head slightly off the end and their arms and legs hanging down. An analysis found that infant sleep sacks are as safe as, if not safer than, other bedding for preventing SIDS. AW2OEnD0=AUiE~za$e a&#cKKB7%uD]_kA7H5JI ]-mmRl:TaUj?:T[ jZu*]$atLZ$N;KMUK^]Q/n0TKv[.U*^D{Z"RWK/8~*5t1Az3IVUK&p?UVK..mU Av_0.";vK~J6[lWpa5L(,.]R1DO#82"4OI":aFfc#GnC8,tCrdq#K']#tGG#w@D!rcGp@TmPA68 XA$ Although in the past FDA has approved a number of these products for GERD or flat head syndrome, new . You can do your part to keep your baby safe by not using sleep. Thank you, {{form.email}}, for signing up. CPSC: Consumer Blog https://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: Preventing Sudden Infant Death Syndrome (SIDS) Overview, AAP: Policy Statement on SIDS http://pediatrics.aappublications.org/content/116/5/1245.full. They'll have their wits about them a little bit more.. Always put babies on their backs to sleep. If you take necessary precautions, a baby can roll over after being able to do so. 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. As a new parent, one of the biggest challenges is helping your baby sleep so that you too can get some much-needed rest. 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. Up until now, the safety of many infant sleep products was determined only by the manufacturer. Most of the infants suffocated after rolling from a side to stomach position. 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 Smart Socks are a wearable device designed to keep an eye on a childs health. WEDNESDAY, Oct. 4, 2017 (HealthDay News) -- Infants should be put to sleep on their backs on a firm, empty surface and never placed on a sleep positioner, the U.S. Food and Drug Administration (FDA) says. Although some days it can feel impossible, getting enough sleep yourself can help keep your baby safe. Predicate Comparison Comparison NightFormn' Infant Sleep Pedicraft Reflux Wedge Positioner K 905629 Application Sleep positioning Sleep positioning 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. may be regulated by the Consumer Product Safety Commission. Infants should always be put to sleep on their back on a firm, bare surface. The victims ranged in age from 21 days to 4 months. Smart Socks were discovered to be unapproved for general distribution as well. You can flip your baby over if they get stuck in their stomach while theyre sleeping. Click Here to request a login to purchase online. For babies under the age of six months, it is a mat with pillows attached to one side. 2005 - 2023 WebMD LLC. (}" X,C#y)D Uv) c:J4 cq q[;C""q""$1Bq#A"crdpp"N8sD w8"8%*K$9""X"8 F>Lq8r,vo)) rJ"815%XD!dx"$9%ErcG8q1,D\H%v8#ALqG|"HHq$HQS3; #=rrqHDKG03geC9H! New Customer? 18 0 obj << /Filter /FlateDecode /Length 19 0 R >> stream The U.S. Consumer Product Safety Commission (CPSC) is charged with protecting the public from unreasonable risk of injury or death associated with the use of thousands of types of consumer products. Although flat head syndrome may worsen as time passes, it usually improves over time. The following guidelines can help families reduce the risk of SIDS. The warmth and comfort of a sleep sack can be provided by providing a blanket without the risk of sliding on it. The answer is yes, and its a common question heard during the wearable blanket vs. swaddle debate. c DD8!# B1)A| N<18CHp@DDF!g(wBB ja1,q090XQJeBkdz$8x'U#cDvGv&bDQPC The agency urged parents and caregivers to always put babies on their back for naps and when they go to sleep at night. Officials are urging parents to follow these safety steps: A few infant sleep positioners have been cleared by the FDA to treat specific medical conditions, such as gastroesophageal reflux. Infants may suffocate after rolling from a side to stomach position or after being placed on their sides in the positioning product. The two main types of infant sleep positioners are flat mats with side bolsters or inclined (wedge) mats with side bolsters. It is critical to ensure that your infant is restrained within the sacks confines and not moved too far, as excessive movement can be harmful. Infant Sleep Positioner Fatalities 1/1/1997 to 8/20/2009* Children 0 - 23 Months of Age *This spreadsheet was prepared by CPSC staff, has not been . It is only recommended that a babys head be removed if he or she is at risk of suffocation or GER symptoms persist. "Because there's no scientific evidence that sleep positioners protect against SIDS and suffocation, they make gastroesophageal reflux better, or they prevent flat head, and given that there is at least a risk of injury or even death when infants are placed in these devices," she said, "to me, they do not pass the test of 'First, do no harm.'". Consumer Product Safety Commission. 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. Accept support from others, no matter how small, so you can rest. The novelty of rolling over in the crib fades as soon as it begins. the FDA had approved . The FDA is warning parents and other caregivers not to use infant sleep positioners because the baby may die from suffocation. This device gives nurses a vital tool in their daily . Sadly, for some parents, this couldnt be further from the truth. A newborn drop is a fall in which a baby being held or carried by a health care professional, parent . Several companies market products that help to alleviate the symptoms of gastroesophageal reflux disease (GERD). Get regular FDA email updates delivered on this topic to your inbox. Christina Johns, MD, pediatrician and medical senior advisor at PM Pediatrics says, Have I seen tragedies within my career? The positioners are meant to keep infants under 6 months old in a specific position while sleeping. Not all products are included in the new rule. The other is an inclined wedge mat with side bolsters. The new safety standard also does not apply to products that are already covered by a separate preexisting federal safety standard including; CPSC admits that wedges and sleep positioners are not included under the new rule because they may be identified as a medical device in some instances. To reduce the risk of sleep-related infant deaths, including accidental suffocation and Sudden Infant Death Syndrome (SIDS), the American Academy of Pediatrics recommends that infants sleep on their backs, positioned on a firm, empty surface. 2021;147(5):e2020035873. . The OEKO-TEX certification system is a non-profit organization that provides independent testing and certification for high-quality products. 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. Verywell Family's content is for informational and educational purposes only. * This document was prepared by CPSC staff, has not been reviewed or approved by, and may not necessarily reflect the views of the Commission. How Should Babies Sleep? Officials Warn Sleep Positioners Pose Suffocation Risk. Despite this, they do have safe sleeping guidelines that can assist parents in preventing SIDS. The FDA intends to take action against device manufacturers who make unproven medical claims about their products. Sleep sacks are credited with reducing SIDS cases in the 1990s. You may wish to review the privacy policy of the external site as its information collection practices may differ from ours. SOURCE: U.S. Food and Drug Administration, news release, Oct. 3, 2017, 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, Smoking Pot Every Day Linked to Heart Risks, Artificial Sweetener Linked to Heart Risks, FDA Authorizes First At-Home Test for COVID and Flu, 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. Read our, How to Survive (and Thrive) When You're Sleep Deprived, A Safety Warning on Infant Sleep Positioners, How to Know a Product Meets the Standards. According to the National Database of Nursing Quality Indicators (2016, pp. 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. As a result, sleep problems are usually short-lived and go away quickly. Due to aggressive automated scraping of FederalRegister.gov and eCFR.gov, programmatic access to these sites is limited to access to our extensive developer APIs. This reduces the risk of SIDS (Sudden Infant Death Syndrome). Owlet has not been sued in another country, as far as we know. When you visit the site, Dotdash Meredith and its partners may store or retrieve information on your browser, mostly in the form of cookies. All rights reserved. Fisher-Price and Kids2 Announce Second Rocker Recall After More Infant Deaths, The Best Baby Loungers for Support in Any Position, How to Choose a CPSC-Certified Bedside Bassinet for Your Baby, Millions of 4moms MamaRoo Swings and RockaRoo Rockers Recalled, Safety Standard for Bassinets and Cradles, American Academy of Pediatrics Safe Sleep recommendations, CPSC approves major new federal safety standard for infant sleep products, Safety standard for infant sleep products, Explaining sudden unexpected infant deaths, 20112017, Do not use infant sleep positioners due to the risk of suffocation, How to keep your sleeping baby safe: AAP policy explained, Safety standard for bassinets and cradles, Bassinets and cradles business guidance & small entity compliance guide. Baby positioning pillow for new born infants with reflux, colic, or NAS babies. You can do your part to keep your baby safe by not using sleep positioners. CPSC does not control this external site or its privacy policy and cannot attest to the accuracy of the information it contains. This type of pillow can be placed under the babys back or behind their head to help keep them from rolling over. Infant Sleep Products Must Now Meet CPSC's New Safety Standards. In this latest report, researchers from the CDC, FDA, and CPSC reviewed data on deaths related to infant sleep positioners from January 1997 to March 2011. Every year about 4,000 infants die unexpectedly while sleeping due to suffocation, SIDS or another unknown cause, according to the Eunice Kennedy Shriver National Institute of Child Health and Human Development. NL G|P8dYN3#(av>GDD \Va2!s{(v[dr6>>&R:t \]6 GR`2Ibi8F%|fN76WLf The FDA discourages consumers from purchasing any product claiming to reduce a babys SIDS risk. But while some products were previously approved for GERD and flat head syndrome, the FDA asked these companies to stop marketing these items since the risks associated with their use outweighed any possible benefits. While the use of sleep positioners may seem like a good idea, there are some potential risks that parents should be aware of before using one. Babies should never sleep with a positioner, pillow, blanket, sheets, a. r8j\}E ^ Thgq.H:j Our website is not intended to be a substitute for professional medical advice, diagnosis, or treatment. We have clinics in Grapevine/Southlake and Plano, Texas, but we also serve clients from throughout Collin County and the North Dallas area. According to the CPSC, this increased the risk of sudden infant death syndrome (SIDS). CPSC's work to ensure the safety of consumer products has contributed to a decline in the rate of injuries associated with consumer products over the past 50 years. In 2010, the FDA became aware of infant positioners being marketed with SIDS claims and. If a baby is swaddled in a blanket, it is advised to be closely monitored for signs that it will roll onto its stomach. You want your child to be mobile. Infant sleep products that don't already meet existing standards will now have to be tested to confirm. This surface should not contain soft objects, toys, pillows, or loose bedding. There are many products on the market that claim to be FDA approved infant sleep positioners, but there is no such thing as an FDA approved infant sleep positioner. Many of these cases occur when parents use a product that is intended for sleep and therefore trust will keep their baby safe. The Owlet Smart Sock 2 is a new product that contains some features that have not been approved by the FDA. Sleep sacks are generally considered to be safe for babies and young children. Neonatal Loving Kares NICU Infant ID Bracelets (patent pending) come in extremely soft, flame retardant material that is extra gentle on the skin of newborns and preemies. If your baby falls asleep in a car seat, stroller, swing, infant carrier, or sling, you should move him or her to a firm sleep surface on his or her back as soon as possible, says Fleming. When you sleep on your back, you are less likely to develop SIDS (Sudden Infant Death Syndrome). It requires infant sleep products to have a surface angle of no more than 10 degrees. 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. Sleep positioners are devices that are placed in the crib, bassinet, or play yard to position an infant on his or her back or side. q 622.08 0 0 806.4 0 0 cm /Im0 Do Q endstream endobj 21 0 obj 36 endobj 22 0 obj << /Type /Xobject /Subtype /Image /Name /Im0 /Filter /CCITTFaxDecode /Width 1728 /Height 2240 /BitsPerComponent 1 /ColorSpace /DeviceGray /DecodeParms << /K -1 /Columns 1728 >> /Decode [ 0 1 ] /Length 23 0 R >> stream You can report an incident or injury from an infant sleep positioner tothe FDAs MedWatch program. This can be helpful for babies who have a flat head, as it can help prevent the head from becoming misshapen. Mandatory safety standards apply to infant sleep products starting June 23, 2022. Others include new standards for cribs and bassinets that are under development and efforts to educate parents about keeping soft bedding out of the infant sleep environment and placing babies on their back to sleep at night and during nap time. 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). (r!Pm6ac(pD~P9Cdr.#qAeD91pA#PX C"B,BEnp98) 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 . Feedback from neonatal nurses, as well as the manner in which preemies respond, offer comforting validation as to the benefits of this product. In most cases, the infants got out of position, rolled onto their stomachs and suffocated, the FDA explained. Renting a Snoo for the duration of your stay is most likely the best option because it is only used for 4-6 months. Federal officials also reported that infants have died after being placed in one of these products. The syndrome usually resolves by the age of two, though it may take a little longer if you try to change babys position when he is awake. The rule includes products marketed or intended for sleep in babies under the age of 5 months old that are not already covered under an existing CPSC regulation. Some sleep positioner companies claim that their products prevent SIDS. learn more about safe sleeping environments on NICHDs website, notifiedmanufacturers to stop marketing these devices and submit information to support FDA clearance, more advice about baby products on the FDAs website. Do Not Sell or Share My Personal Information. Baby spits get into their windpipe when they are healthy, but they cough if they get in. Most of the infants suffocated after rolling from a side to stomach position. Assuming you would like tips for helping a baby sleep in a fixed position: One way to help a baby sleep in a fixed position is to use an anti roll pillow. The site is secure. 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. Some manufacturers have advertised that their sleep positioners prevent SIDS; gastroesophageal reflux disease (GERD), in which stomach acids back up into the esophagus; or flat head syndrome (plagiocephaly), a deformation caused by pressure on one part of the skull. 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. Sleep sacks come in a variety of fabrics and thickness, as well as a wide range of styles. If you want to request a wider IP range, first request access for your current IP, and then use the "Site Feedback" button found in the lower left-hand side to make the request. According to the FDA announcement, parents should: STOP using infant positioning products. 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. If you need to purchase items before then, focus on items that are covered by existing safety standards, such as bassinets, cribs, play yards, or bedside sleepers. These productssometimes also called nests or anti-roll productscan cause suffocation (a struggle to breathe) that can lead to death. The U.S. Food and Drug Administration is reminding parents and caregivers not to put babies in sleep positioners. Some types of compact or travel bassinets. He said that none of the devices should be used and that "the modest evidence of benefit does not outweigh the risk.". The American Academy of Pediatrics recommends that infants be placed on their backs to sleep to reduce the risk of SIDS. . Some sleep positioners are even inflatable, like a mini-mattress. Even if placed properly on their backs, infants may scoot up or downward on the positioning device, and may become entrapped in the product or between the positioning device and the crib, play yard, sleep mat or bassinet. CPSC chairman Inez Tenenbaum said the warning against infant sleep positioners is one component of the agency's Safe Sleep Initiative. Safety standard for infant sleep products. If you are purchasing sleep products that don't yet have safety standards applied, look for the following features that are considered in the new standard. All current safety rules are available for review on the CPSC website. 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. Spanish: (301) 504-7800, View CPSC contacts for specific areas of expertise, U.S. Consumer Product Safety Commission In general, there is no clear answer because babies are unique, and if there is any concern, consult a pediatrician. kr,mMP`k|f7R /?)33 B=5y*;nujAOYn&M=PbP(&H7^F$J1 oj j}RQ-f$;J 9Gq8HO_F&g|DA?RHHPy,-i$4]}[JFJlAFl9E(q/'Aq&\H]B5H.NRST:>;7MA9W8HJgbU>R;r-;8{]aV,7FH^g[-@\ m6965m1jPV3 *AJyjN`X A, A) X)%-!U@_~F0J+,r-c%r)OJGRfP=OWK}ZH)#dCcOn">ifs2V OjHu%tqX8LEaSy*0n[HA/5,k }X4]a ] l7C* ;\Dd4Zt|g}|S,AA%%OT h(&r=)tIZ\p(Q_SArRngM5t"KgB{EBAB VEf0$`[^\(U 2}q~QZNdoDo&1f@']vD}(fz)ayw# o2}a]q3f6a"! CPSC is interested in receiving incident or injury reports related to these products. To provide your baby with the safest sleep environment, ensure that you are familiar with the American Academy of Pediatrics Safe Sleep recommendations. 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 https://www.accessdata.fda.gov/scripts/medwatch/. 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. Consumer Product Safety Commission. This should only be necessary once for each IP address you access the site from. rcDRq.0Dr$9L8QdpD;9G R:#Bai85H'h!#l@qqdx)\#q80GDcG(qeppnGdq C8P#a88'tDb&,D8n$HD}+PDp R>fB$"=DpC. LE[IVr08"8An8A'r99r. [Rested] parents aren't so exhausted that they'll just do anything or put their child into any particular product, just so that they can get some sleep themselves, she says. * This document was prepared by CPSC staff, has not been reviewed or approved by, and may not necessarily reflect the views of the Commission. Deaths prompt CPSC, FDA warning on infant sleep positioners, https://www.accessdata.fda.gov/scripts/medwatch/, https://www.cpsc.gov/onsafety/2010/09/sleep-positioners-a-suffocation-risk/, http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm227575.htm, http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm227301.htm, http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm227302.htm, http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm227303.htm, Sudden Infant Death Syndrome (SIDS) Overview, http://pediatrics.aappublications.org/content/116/5/1245.full, Report a dangerous product or a product-related injury on. CPSC's work to ensure the safety of consumer productssuch as toys, cribs, power tools, cigarette lighters, and household chemicalscontributed to a significant decline in the rate of deaths and injuries associated with consumer products over the past 30 years. Your pediatrician is trained to help in these situations. Texas WIC Approved Wholesale Distributors . 2022 - Sept. 30, 2023) Infant Formula Manufacturers Registered with the FDA Name Address. Dr. Johns reminds parents that when you, as a parent, are supported and rested, you can make clearer decisions about your babys sleep environment. The deaths and dangerous situations resulting from the use of infant sleep positioners are a serious concern to CPSC, said CPSC Chairman Inez Tenenbaum. Nurture Rest recreates a more in-utero feel for preemies, providing "kangaroo care" in the isolette, while keeping the infant's head, neck, and spine aligned. Avoid soft or padded sides. Sadly, many sleep positioners are advertised to "help prevent SIDS." But the FDA has never approved any infant sleep positioner to reduce the risk of SIDS. It is possible that sleep positioners will initially help you keep your baby in a specific position, but they will probably not be necessary over time. You can create a safe environment by following the ABCs of safe sleep listed below: A: Alone in their own sleeping space, with no other people in the crib or bassinet; B: on their Backs on a firm sleep surface; C: and in a Crib or bassinet free of pillows, blankets, bumpers, sleep positioners, and other objects. Should babies sleep on their side or at a flat angle? Sleep sacks are generally safe and can help infants move more easily. No matter how slim the sleeping bag is, suffocation concerns are not as high. The FDA's Sharfstein said the agency has never approved a sleep position to prevent SIDS. Others suggest their positioners help prevent flat head syndrome (plagiocephaly), a deformation caused by pressure on one part of the skull. PaQcOfb A8 C[P(0c) K7-98EV vcW3DBg88AJa CGL\E&"B|E!Gs"C"A98CG#TGX$mB" They are designed to keep your child warm and snug, and can be used in place of traditional blankets. 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. 2005 - 2023 WebMD LLC. Using this type of product to hold an infant on his or her side or back is dangerous and unnecessary. This is a one-time FDA action, which is only applicable to the United States.