fda approved infant sleep positioner

Login Here to purchase products online. 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. 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. The back of your baby is a good place to sleep for a variety of reasons. Owlet has not been sued in another country, as far as we know. The FDA urged parents and caregivers to talk to their child's doctor if they have questions about putting babies to sleep safely. Appropriate clothing keeps babies warm enough while they are sleeping. Transport Roll used for transporting infants from referring hospitals via helicopter or ambulance. 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. An analysis conducted in 2019 discovered that infant sleep sacks are as safe, if not safer, than other bedding types for preventing sudden infant death syndrome (SIDS). The warmth and comfort of a sleep sack can be provided by providing a blanket without the risk of sliding on it. 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. G>vU)W)"ywAual$9RLCAuryW %N9i5+! 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. The positioners claim to keep a baby in a specific position while sleeping and are often used for babies under 6 months old. The deaths and dangerous situations resulting from the use of infant sleep positioners are a serious concern to CPSC, said CPSC Chairman Inez Tenenbaum. Infant Sleep Positioning Products and Wedges* . "We want to make sure parents, health care professionals, and childcare providers understand the potential risk of suffocation and stop using infant sleep positioners.". This surface should not contain soft objects, toys, pillows, or loose bedding. Some of the most popular sleep positioners on Amazon and Ebay include Tesco, John Lewis, and Boots. The following guidelines can help families reduce the risk of SIDS. Is It Safe To Use A Sleep Positioner Bed For Your Baby? At least nine of the infants were placed on their sides (and one prone), raising the concern that the 'back-to-sleep' message to position infants on their backs is either not being heard or not being followed, researcher Brenda Lawrence, MD, of the FDA, writes in the CDC report. The FDA is not aware of any clinical or scientific evidence that shows that currently available baby products prevent or reduce the chance of SIDS. It is not necessary to place your baby in a positioner or blanket to keep him in this position. June 14, 2022; pros and cons of stem cell therapy for knees . 2005 - 2023 WebMD LLC. 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. 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. 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. It also ensures these products comply with the CPSC's Safety Standard for Bassinets and Cradles. In the first year of life, babies should only be placed on their backs to sleep. Ensure sides are high enough to prevent the infant from falling. You can report an incident or injury from an infant sleep positioner tothe FDAs MedWatch program. fda approved infant sleep positioner - HAZ Rental Center This means that if a product states or implies on its packaging or inserts that a baby may sleep, snooze, dream, or nap in the product, it is covered by this rule. Your Preemie's First Year: What to Expect. In a recent MedWatch release, the United States Food and Drug Administration (FDA) is warning parents of the dangers associated with infant sleep positioners. Materials can be used in a variety of ways. 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. Most of the infants were placed on their sides to sleep in the sleep positioner, and many were later found lying on their stomachs. 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$ It is critical for parents to properly use sleep sacks. Please visit www.saferproducts.gov to file a report. So we can see fewer of those injuries and fatalities that have been recently reported, says Dr. Johns of the new safety standards. Nick Blackmer is a librarian, fact checker, and researcher with more than 20 years experience in consumer-oriented health and wellness content. The American Academy of Pediatrics (AAP) recommends that infants sleep on their backs, positioned on a firm . Bassinets and cradles business guidance & small entity compliance guide. Researchers found all but one of the deaths involved infants aged 3 months or less. The two main types of infant sleep positioners are flat mats with side bolsters or inclined (wedge) mats with side bolsters. 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. 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. l@69hL`k!$Ys.FC)#>J}rE:r+3 sF.X.fC8;L Most of the infants suffocated after rolling from a side to stomach position. The positioners are meant to keep infants under 6 months old in a specific position while sleeping. Call our offices at 214-919-0757 or fill out our online form. The FDA is warning parents and other caregivers not to use infant sleep positioners because the baby may die from suffocation. Infant Sleep Positioners Pose Suffocation Risk, F.D.A. Says . 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). ET. Several options for providing this sleep exist, and some parents are wondering whether to allow their babies to sleep in a rocker, car seat, or even a pillow. No . 2021;147(5):e2020035873. Texas WIC Approved Wholesale Distributors . You should also make sure to follow the manufacturer's instructions carefully 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. CPSC is interested in receiving incident or injury reports related to these products. Fed Regist. 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. Knowing what your baby needs can be very confusing when youre faced with an array of products. The agency urged parents and caregivers to always put babies on their back for naps and when they go to sleep at night. 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. Create a support network of friends, family, and professional help where you can. 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. Dr. Johns reminds parents that when you, as a parent, are supported and rested, you can make clearer decisions about your babys sleep environment. Baby spits get into their windpipe when they are healthy, but they cough if they get in. Outside of this, sleep positioners and sleep wedges are not recommended. All rights reserved. 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. Patented, FDA Approved Nurture Rest NICU Infant Sleep Positioner for premature babies. Be aware that any product that claims to prevent or reduce the chance of SIDS has never been cleared or approved for that use by the FDA. Baby Sleep Positioners Unsafe, Say FDA, CPSC - CBS News Sleep wedge pillows and sleep positioners are out of scope, and may be covered by FDA regulations as a medical device if they are marketed to treat a medical condition such as acid reflux, explains Fleming. These baby products can pose a risk of serious injury to a baby, including the risk of suffocation. 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. Some newer models, such as the Tranquilo Safe Sleep Swaddle Blanket and the Swanling Slumber Sleeper, are specifically designed to keep your baby asleep by preventing them from rolling over. Recommendations for Parents / Caregivers About the Use of Baby Products %PDF-1.4 % They'll have their wits about them a little bit more.. fda approved infant sleep positioner. The FDA and U.S. Consumer Product Safety Commission (CPSC) also issued a warning against the use of sleep positioners in 2010. When you visit the site, Dotdash Meredith and its partners may store or retrieve information on your browser, mostly in the form of cookies. The only way for a baby to sleep safely is on his or her back in a crib. 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. At least 13 infants have died since 1997 while lying in sleep positioners or sleep wedges, a new CDC report shows. This should only be necessary once for each IP address you access the site from. Click Here to request a login to purchase online. c DD8!# B1)A| N<18CHp@DDF!g(wBB ja1,q090XQJeBkdz$8x'U#cDvGv&bDQPC For babies under the age of six months, it is a mat with pillows attached to one side. Oct. 2, 2010— -- Baby sleep positioners -- mats with barriers to prevent a baby from rolling over -- carry a risk of suffocation and death, and should not be used under any circumstances, the FDA and Consumer Product Safety Commission (CPSC) warned. }Qova{i!{h.FPHh endstream endobj 19 0 obj 1894 endobj 20 0 obj << /Length 21 0 R >> stream Renting a Snoo for the duration of your stay is most likely the best option because it is only used for 4-6 months. Nests or anti-roll supports are two types of sleep positioners. For detailed information on safe sleep environments, review the CDC or AAP guidelines on safe infant sleeping. But putting babies to sleep on or near soft objects, such as positioners, toys, pillows and loose bedding, increases the risk for accidental suffocation and Sudden Infant Death Syndrome (SIDS), the American Academy of Pediatrics says. 2013;78:63019-63036. [Rested] parents aren't so exhausted that they'll just do anything or put their child into any particular product, just so that they can get some sleep themselves, she says. Nurture Rest recreates a more in-utero feel for preemies, providing "kangaroo care" in the isolette, while keeping the infant's head, neck, and spine aligned. Four of the 13 infants also had recent respiratory symptoms, such as a cold. WebMD does not provide medical advice, diagnosis or treatment. All current safety rules are available for review on the CPSC website. Infant sleep positioners that are used to keep babies on their backs and protect them from sudden infant death syndrome have led 12 children to suffocate in the past 13 years and should no. 'Sleep Positioners' a Danger to Baby: FDA - webmd.com 3F,lrk=cPj[;478='{![!0@ 6Hn!\O K KdF5R/zL0ltZ$^.c2H:jbX&I1\4Tf-! Sleep sacks are generally considered to be safe for babies and young children. 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. 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. No matter how slim the sleeping bag is, suffocation concerns are not as high. 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. Save my name, email, and website in this browser for the next time I comment. A newborn drop is a fall in which a baby being held or carried by a health care professional, parent . Please include the following information in your reports: An official website of the United States government, : Federal officials also reported that infants have died after being placed in one of these products. The FDA intends to take action against device manufacturers who make unproven medical claims about their products. Sleep sacks are generally safe and can help infants move more easily. So its no wonder that many parents turn to sleep positioners, also known as nest or crib wedges, in an effort to help their baby sleep more soundly. . The FDA has approved a special sleep positioner for infants with GERD. Feedback from neonatal nurses, as well as the manner in which preemies respond, offer comforting validation as to the benefits of this product. October 3, 2017 - The U.S. Food & Drug Administration (FDA) is warning parents and caregivers not to leave babies in sleep positioners unattended due to a risk of suffocation, which could lead to death. Although some days it can feel impossible, getting enough sleep yourself can help keep your baby safe. And these are not the result of negligent parents who are not taking care of their infants. Do not use infant sleep positioners due to the risk of suffocation. CPSC does not control this external site or its privacy policy and cannot attest to the accuracy of the information it contains. The FDA discourages consumers from purchasing any product claiming to reduce a babys SIDS risk. Neonatal Loving Kare. O2 Pulmonary & Sleep Group is committed to diagnosing and providing care for your pulmonary or sleep disorder. 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. Consumers can also view a video about this issue. If youre not sure, ask your pediatrician. and CPSC reviewed data on deaths related to infant sleep positioners from January 1997 to March 2011. 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. Every year approximately 4,000 infants are killed in unexpected deaths while sleeping, which can be suffocation, sudden infant death syndrome, or another unknown cause. Federal law prohibits any person from selling products subject to a Commission ordered recall or a voluntary recall undertaken in consultation with the CPSC. All rights reserved. . 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. Sharfstein said on a conference call with reporters that he is not aware of any studies supporting that claim. The American Academy of Pediatrics recommends that infants be placed on their backs to sleep to reduce the risk of SIDS. Safety standard for infant sleep products. Do Not Use Infant Sleep Positioners Due to the Risk of Suffocation | FDA The .gov means its official.Federal government websites often end in .gov or .mil. In most of these cases, the babies suffocated after rolling from their sides to their stomachs. The best place for babies to sleep on their backs is on a firm, bare surface. The position is safer for babies, and there is a lower risk of SIDS. Sleep sacks are credited with reducing SIDS cases in the 1990s. Recommendations for Parents / Caregivers About the Use of Baby Products 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. (r!Pm6ac(pD~P9Cdr.#qAeD91pA#PX C"B,BEnp98) Is a Bassinet or a Crib Better for My Baby? 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. To provide your baby with the safest sleep environment, ensure that you are familiar with the American Academy of Pediatrics Safe Sleep recommendations. 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 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. Dr. Rachel Moon, a pediatrician at Children's National Medical Center in Washington and chair of the SIDS task force for the American Academy of Pediatrics, said the AAP supports the warning about the sleep positioners. As a result, sleep problems are usually short-lived and go away quickly. Applicable products manufactured in the United States, or imported for sale in the United States, from June 23, 2022, must comply with the rule. It also reduces your babys chances of developing shoulder dystocia in the second year after birth. A baby sleep positioner is a device that is designed to help keep a babys head in a certain position while sleeping. So any product that offers a soothing sleep to your baby sounds like a godsend. The only things in the crib should be the baby and a tightly fitting crib sheet. In general, there is no clear answer because babies are unique, and if there is any concern, consult a pediatrician. Any soft surface is a suffocation risk for infants. Smart Socks can be dangerous for children because they could be swallowed. Fed Regist. MNfGtGDvGfGAqAb%"%+&PgIpE8`s$CF:/y:#8eGD! Neonatal Loving Kare - Infant Positioning Devices & Accessories Do Not Sell or Share My Personal Information. The agency urged parents and caregivers to always put babies on their back for naps and when they go to sleep at night. An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, Do Not Use Infant Sleep Positioners Due to the Risk of Suffocation. "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.'". They are designed to keep your child warm and snug, and can be used in place of traditional blankets. 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. Nychelle Fleming, CPSC spokesperson reminds parents to remove their children from these products if they do fall asleep. G` DJz! Pulmonologist & Sleep Disorders | O2 Pulmonary & Sleep Group Prevention of Newborn Falls/Drops in the Hospital: AWHONN Practice 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. 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. 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. Infant Sleep Products Must Meet CPSC Safety Standards - Verywell Family 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. Details of Adverse Event and Medical and/or Surgical Interventions (if applicable). 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. 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"! Infant Sleep Products Must Now Meet CPSC's New Safety Standards. 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. How Should Babies Sleep? The FDA has never approved any infant sleep positioner to prevent or reduce the risk of SIDS. 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. Safety standard for bassinets and cradles. Most of the infants suffocated after rolling from a side to stomach position. Using this type of product to hold an infant on his or her side or back is dangerous and unnecessary. The Risks Of Sleep Positioners For Infants - TheEcoBaby Cookies collect information about your preferences and your devices and are used to make the site work as you expect it to, to understand how you interact with the site, and to show advertisements that are targeted to your interests. Some sleep positioners are even inflatable, like a mini-mattress. Spanish: (301) 504-7800, View CPSC contacts for specific areas of expertise, U.S. Consumer Product Safety Commission It is only recommended that a babys head be removed if he or she is at risk of suffocation or GER symptoms persist. R(qL9CC\H"qa$]! Sleep sacks, when used properly, not only keep babies warm while lowering the risk of SIDS, but they also help to keep babies sleepy. The FDA is aware of infant deaths from these products over the years. CPSC approves major new federal safety standard for infant sleep products. This is important because babies who sleep on their stomachs are at an increased risk for sudden infant death syndrome (SIDS). To the untrained and tired eye, navigating the safety profile of every product is confusing and time-consuming. 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. Your Preemie's First Year: What to Expect. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Sharfstein said the agency has not heard back from all of the device makers, but expects all of them to comply with the demands. 2021;86:33022-33072. With a small, handheld remote, you simply turn on Inspire before you go to sleep. There may be underlying reasons why your baby is unsettled. Sleep positioning products were created to keep a baby sleeping on its back or side. FDA-approved Inspire sleep apnea treatment works with your natural sleep process treating obstructive sleep apnea so you keep breathing through the night. 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. Toll-Free Consumer Hotline | Time: 8 a.m. - 5.30. p.m. An official website of the United States government. Consumer Product Safety Commission. Deaths, injuries, and property damage from consumer product incidents cost the nation more than $800 billion annually. 13 Infant Deaths Tied to Sleep Positioners - WebMD Up until now, the safety of many infant sleep products was determined only by the manufacturer. 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{ 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. One is a flat mat with a side bolster. FDA Issues Suffocation Warning On Infant Sleep Positioners At what age is sleep sacks for kids safe? Predicate Comparison Comparison NightFormn' Infant Sleep Pedicraft Reflux Wedge Positioner K 905629 Application Sleep positioning Sleep positioning If you take necessary precautions, a baby can roll over after being able to do so. The FDA's Sharfstein said the agency has never approved a sleep position to prevent SIDS. Babies typically correct themselves if they are allowed to sit on their own.

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