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4330 East-West Highway Bethesda, MD 20814, Contact Us: 800-638-2772 (TTY 800-638-8270) Most sleep sacks are made from lightweight materials such as cotton or fleece, and have a zip or Velcro closure. Neonatal Loving Kare. Nestle, USA (Nestle Infant . Your pediatrician is trained to help in these situations. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. The FDA regulates baby products that claim to cure, treat, prevent or reduce a disease or condition. 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. 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. G>vU)W)"ywAual$9RLCAuryW %N9i5+! The warmth and comfort of a sleep sack can be provided by providing a blanket without the risk of sliding on it. A number of sleep positioners are considered medical devices because of their intended use. 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.. You can report an incident or injury from an infant sleep positioner tothe FDAs MedWatch program. Fleming recommends that looking for a product manufacture date of June 23, 2022, or later will indicate that your product must meet the new standards. 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. Toll-Free Consumer Hotline | Time: 8 a.m. - 5.30. p.m. A baby who can roll over on his or her back can safely sleep in a weighted sleep sack with a weight of no more than 10% of his or her body weight. The CPSC is committed to protecting consumers and families from products that pose a fire, electrical, chemical, or mechanical hazard. 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. "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. Neonatal Loving Kare, Inc. Transport Roll is used for transporting infants from referring hospitals via helicopter or ambulance. A baby sleep positioner is a device that is designed to help keep a babys head in a certain position while sleeping. 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. A 100% cotton blend made from Australian olive tree, which is effective in breathable, antibacterial, anti-mite, and insect control. The FDA is warning parents and other caregivers not to use infant sleep positioners because the baby may die from suffocation. As a result, sleep problems are usually short-lived and go away quickly. Products called nests can feature soft, wall-like structures that surround the base. 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. ET. All rights reserved. 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. These baby products can pose a risk of serious injury to a baby, including the risk of suffocation. To join a free email subscription list, go to www.cpsc.gov/cpsclist.aspx, The FDA is responsible for protecting the public health by assuring the safety, efficacy, and quality of human and veterinary drugs, biological products, medical devices, the nation's food supply, cosmetics, and products that emit radiation. 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. The FDA has never cleared an infant sleep positioner to prevent or reduce the risk of SIDS. There are a variety of different types of baby sleep positioners available, so it is important to choose one that is comfortable for your child and that will fit their crib or bassinet. It also reduces your babys chances of developing shoulder dystocia in the second year after birth. Some companies market their products as helpful for easing gastroesophageal reflux disease (GERD), a condition that causes stomach acids to back up into the esophagus. Oct. 2, 2010— -- Baby sleep positioners -- mats with barriers to prevent a baby from rolling over -- carry a risk of suffocation and death, and should not be used under any circumstances, the FDA and Consumer Product Safety Commission (CPSC) warned. The American Academy of Pediatrics (AAP) recommends that infants sleep on their backs, positioned on a firm . The U.S. Consumer Product Safety Commission is charged with protecting the public from unreasonable risks of injury or death associated with the use of the thousands of types of consumer products under the agency's jurisdiction. (r!Pm6ac(pD~P9Cdr.#qAeD91pA#PX C"B,BEnp98) The .gov means its official.Federal government websites often end in .gov or .mil. Transport Roll used for transporting infants from referring hospitals via helicopter or ambulance. Researchers found all but one of the deaths involved infants aged 3 months or less. doi:10.1542/peds.2020-035873. We urge parents and caregivers to take our warning seriously and stop using these sleep positioners, so that children can have a safer sleep.. OWW'^M&~{#(7ry_"uSFBU[Er\X&oY9oq Z/u;tvM^WAL"#mrY0g\HX7p4\` Infant sleep positioners - using this type of product to hold an infant on his or her side or back is dangerous and unnecessary, crib bedding, including bumpers and blankets. The FDA's Sharfstein said the agency has never approved a sleep position to prevent SIDS. Some babies have been found in dangerous positions next to a positioner they had been placed in for sleeping. Sleeping positioners, bumper pads, blankets, stuffed animals, and other items that provide a safe sleeping environment are not permitted. Before sharing sensitive information, make sure you're on a federal government site. 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). The American Academy of Pediatrics (AAP) also discourages routine use of SIDS monitors. The FDA does not approve any products for infants to sleep in. 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. Four of the infants had been born prematurely and three were one of a set of twins. If you are using a sleep sack for the first time, it is a good idea to ask your pediatrician for advice. 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. Sadly, for some parents, this couldnt be further from the truth. 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. The sleep sack is intended to make the baby feel secure and held, which can help to calm them down. Does sleep sacks have an effect on health? 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. 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 . The only things in the crib should be the baby and a tightly fitting crib sheet. (}" 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! 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. 24/7 coverage of breaking news and live events. The CPSC has also received dozens of reports of infants put to sleep on their backs or sides in positioners and later found in a potentially dangerous position. Four of the 13 infants also had recent respiratory symptoms, such as a cold. Your Preemie's First Year: What to Expect. Make sure your babys crib position is changed on a daily basis to reduce the likelihood of him having a flat head. Appropriate clothing keeps babies warm enough while they are sleeping. This device gives nurses a vital tool in their daily . To report a dangerous product or a product-related injury, call CPSC's Hotline at (800) 638-2772, teletypewriter at 800-638-8270, or visit www.saferproducts.gov. 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. How to keep your sleeping baby safe: AAP policy explained. Call CPSCs Hotline at 800-638-2772 (TTY 301-595-7054). Update: FDA Warns Against Risk of Suffocation, Death with Sleep Positioners. "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.'". Infant Sleep Products Must Now Meet CPSC's New Safety Standards. Nests or anti-roll supports are two types of sleep positioners. If a baby is swaddled in a blanket, it is advised to be closely monitored for signs that it will roll onto its stomach. fda approved infant sleep positioner. Christina Johns, MD, pediatrician and medical senior advisor at PM Pediatrics says, Have I seen tragedies within my career? Fed Regist. You can do your part to keep your baby safe by not using 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. 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. 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. 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/. Baby positioning pillow for new born infants with reflux, colic, or NAS babies. 18 0 obj << /Filter /FlateDecode /Length 19 0 R >> stream In the first year of life, babies should only be placed on their backs to sleep. Verywell Family's content is for informational and educational purposes only. If you experience an injury or malfunction when using an infant sleep positioner, we encourage you to file a voluntary report by phone at 1-800-FDA-1088 or online at MedWatch, the FDA Safety Information and Adverse Event Reporting program. 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. Fed Regist. 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. However, the FDA clearly states that sleep positioners should not be used and are dangerous for infants. For detailed information on safe sleep environments, review the CDC or AAP guidelines on safe infant sleeping. Safe baby sleep positioners are devices that are designed to keep your baby in a specific position while sleeping. The back of your baby is a good place to sleep for a variety of reasons. This can be helpful for babies who have a flat head, as it can help prevent the head from becoming misshapen. The National Institute of Child Health and Human Development recommends that the best way to reduce the chance of SIDS is to create a safe sleep environment for a baby. Neonatal Loving Kare specializes in developmental care products for NICU departments. The answer is yes, and its a common question heard during the wearable blanket vs. swaddle debate. The two main types of infant sleep positioners are flat mats with side bolsters or inclined (wedge) mats with side bolsters. The link you selected is for a destination outside of the Federal Government. Call our offices at 214-919-0757 or fill out our online form. Two of the most common types of sleep positioners have supports attached to each side of a mat or a wedge used to raise a baby's head. The FDA intends to take action against device manufacturers who make unproven medical claims about their products. Once implemented, the new standards will help parents navigate the often confusing aisles of the baby store by ensuring that the sleep products available meet national safety standards. 2013;78:63019-63036. What Happens When Your Son Is Circumcised? We invite you to use the Nurture Rest positioning device. }Qova{i!{h.FPHh endstream endobj 19 0 obj 1894 endobj 20 0 obj << /Length 21 0 R >> stream Federal officials also reported that infants have died after being placed in one of these products. The federal government has received reports about babies who have died from suffocation associated with their sleep positioners. The site is secure. For babies under the age of six months, it is a mat with pillows attached to one side. 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. lauren donovan leaving iowa; platine arrache souche; danny trevathan youngstown, ohio; merion cricket club summer membership Sleep sacks are a type of wearable blanket that are typically used for infants and young children. Texas WIC Approved Wholesale Distributors . When you visit the site, Dotdash Meredith and its partners may store or retrieve information on your browser, mostly in the form of cookies. 2021;147(5):e2020035873. As nurses, you will see how your preemies respond to this product. 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. Accept support from others, no matter how small, so you can rest. 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. (This intended use can be outlined by statements made on the labels, labeling, instructions for use, or promotional materials for the products.). You want your child to be mobile. 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. . Snoo Smart Sleeper Bassinet is currently under review by the FDA as the first device to prevent the leading causes of sudden infant death syndrome (SIDS). CPSC is interested in receiving incident or injury reports related to these products. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. If you are struggling with getting your baby to sleep, speaking to your pediatrician is advised. News release, Consumer Product Safety Commission. As a result, the Consumer Product Safety Commission (CPSC) advises parents not to allow their babies to sleep in these positions because they are held at an incline and head higher than their feet. 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. 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. @!Q#.$D|DDaDDPB&N;9C9[ARC "8PAe! And these are not the result of negligent parents who are not taking care of their infants. 2005 - 2023 WebMD LLC. The U.S. Food and Drug Administration is reminding parents and caregivers not to put babies in sleep positioners. Baby Products with SIDS Prevention Claims, Recalls, Market Withdrawals and Safety Alerts, Baby Products with SIDS Prevention Claims, Information for Manufacturers of Baby Products, Recommendations for Parents / Caregivers About the Use of Baby Products, National Institute of Child Health and Human Development, MedWatch, the FDA Safety Information and Adverse Event Reporting program, Infant Sleep Positioners Pose Suffocation Risk. The FDA advises babies not to sleep with positioners, pillows, blankets, sheets, or comforters. This is a device that goes over the babys mattress and has straps or other features to help keep the baby in one spot. the FDA had approved . The AAP does not recommend using Rockn Play products that require restraint in order to allow infants to sleep. Babies should never sleep with a positioner, pillow, blanket, sheets, a comforter or a quilt, the FDA advised. He said FDA has approved 18 sleep positioner products over the years, mostly for reflux or. Babies typically correct themselves if they are allowed to sit on their own. * This document was prepared by CPSC staff, has not been reviewed or approved by, and may not necessarily reflect the views of the Commission. Dr. Johns reminds parents that when you, as a parent, are supported and rested, you can make clearer decisions about your babys sleep environment. Fda Approved Infant Sleep Positioner. Baby sleeping bags, also known as sleep sacks, are Wearable blankets that keep your baby warm during the night. How Should Babies Sleep? 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. 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. The FDA is aware of infant deaths from these products over the years. Setting up a safe sleep environment and being familiar with recommendations is easiest to do before your baby is born, but essential at any stage of your journey. Infants may suffocate after rolling from a side to stomach position or after being placed on their sides in the positioning product. 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. 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. So we can see fewer of those injuries and fatalities that have been recently reported, says Dr. Johns of the new safety standards. You may wish to review the privacy policy of the external site as its information collection practices may differ from ours. Some of the most popular sleep positioners on Amazon and Ebay include Tesco, John Lewis, and Boots. It is time to turn off a temperature-controlled full night of sleep for your baby. Although in the past FDA has approved a number of these products for GERD or flat head syndrome, new . Patented, FDA Approved Nurture Rest NICU Infant Sleep Positioner for premature babies. Its exciting and terrifying at the same time. To the untrained and tired eye, navigating the safety profile of every product is confusing and time-consuming. Infants' sleeping surfaces should be bare and free of any loose items. This is a one-time FDA action, which is only applicable to the United States. Although flat head syndrome may worsen as time passes, it usually improves over time. The agency warned parents and caregivers that these products, also known as "nests" or "anti-roll" supports, can prevent babies from breathing. The FDA urged parents and caregivers to talk to their child's doctor if they have questions about putting babies to sleep safely. Materials can be used in a variety of ways. What do you think about using baby sleep positioners? 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$ The novelty of rolling over in the crib fades as soon as it begins. 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 . The FDA is committed to providing accurate, science-based information to the public on the products it regulates. At least 13 infants have died since 1997 while lying in sleep positioners or sleep wedges, a new CDC report shows. These productssometimes also called nests or anti-roll productscan cause suffocation (a struggle to breathe) that can lead to death. Is a Bassinet or a Crib Better for My Baby? The .gov means its official.Federal government websites often end in .gov or .mil. 2022 - Sept. 30, 2023) Infant Formula Manufacturers Registered with the FDA Name Address. 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"! This reduces the risk of SIDS (Sudden Infant Death Syndrome). "We want to make sure parents, health care professionals, and childcare providers understand the potential risk of suffocation and stop using infant sleep positioners.". Inspire is a tiny pacemaker-like device that is implanted during a quick outpatient surgery. New Customer? Because the FDA can't force a recall without a very lengthy legal process, babies continue to be . Get regular FDA email updates delivered on this topic to your inbox. Most parents find that their baby outgrows the need for a positioner by 4 to 6 months old. The FDA intends to take action against device manufacturers who make unproven medical claims about their products. Thank you, {{form.email}}, for signing up. 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. 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. 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. You should also make sure to follow the manufacturer's instructions carefully Instead of the back, an infant should sleep on their back with no bumpers, bedding, or stuffed animals. It is possible for infants to sleep in a larger sleep sack that can comfortably fit them between the knees and shoulders, weighing about 30 pounds and 40 inches. Nurture Rest recreates a more in-utero feel for preemies, providing kangaroo care in the isolette, while keeping the infants head, neck, and spine aligned. rcDRq.0Dr$9L8QdpD;9G R:#Bai85H'h!#l@qqdx)\#q80GDcG(qeppnGdq C8P#a88'tDb&,D8n$HD}+PDp R>fB$"=DpC. LE[IVr08"8An8A'r99r. 3F,lrk=cPj[;478='{![!0@ 6Hn!\O K KdF5R/zL0ltZ$^.c2H:jbX&I1\4Tf-! Pillowing, wedges, comforters, or quilts are commonly placed beneath bassinets or cribs. Most of the infants suffocated after rolling from a side to stomach position. In most of these cases, the babies suffocated after rolling from their sides to their stomachs. The OEKO-TEX certification system is a non-profit organization that provides independent testing and certification for high-quality products. Baby spits get into their windpipe when they are healthy, but they cough if they get in. And you can find more advice about baby products on the FDAs website. 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. Deaths, injuries, and property damage from consumer product incidents cost the nation more than $800 billion annually. Contact Our Sleep & Pulmonary Clinic. 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 results showed 13 deaths. Click Ok if you wish to continue to the website; otherwise, click Cancel to return to our site. 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. Infant Sleep Positioning Products and Wedges* . The only way for a baby to sleep safely is on his or her back in a crib. The FDA has approved a special sleep positioner for infants with GERD. Federal law prohibits any person from selling products subject to a Commission ordered recall or a voluntary recall undertaken in consultation with the CPSC. The two most common sleep positioners include two raised pillows or "bolsters" attached to a mat. The FDA had previously cleared some infant positionersfor GERD or flat head syndrome. The victims ranged in age from 21 days to 4 months. Smart Socks can be dangerous for children because they could be swallowed. They'll have their wits about them a little bit more.. Whats better, sleeping sacks or sleeping swaddles? B. 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.