The Consumer Product Safety Commission (CPSC) rule went into effect on June 23, 2022. There are two main types of infant sleep positioners. Danger: Infant Sleep Positioners - The Doctor Will See You Now Dr. Johns reminds parents that when you, as a parent, are supported and rested, you can make clearer decisions about your babys sleep environment. 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. "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. Owlet, which makes smart socks that track heart rate and sleep, has released a new product in response to a class-action lawsuit. CPSC does not control this external site or its privacy policy and cannot attest to the accuracy of the information it contains. Your Preemie's First Year: What to Expect. Linking to this external site does not constitute an endorsement of the site or the information it contains by CPSC or any of its employees. Finally, if you have questions about how to safely put a baby to sleep, or how to avoid or treat certain health issues, talk to your health care provider. Infant sleep positioners are the subject of a recent FDA warning Inspire is a tiny pacemaker-like device that is implanted during a quick outpatient surgery. OWW'^M&~{#(7ry_"uSFBU[Er\X&oY9oq Z/u;tvM^WAL"#mrY0g\HX7p4\` 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. Babies should never sleep with a positioner, pillow, blanket, sheets, a comforter or a quilt, the FDA advised. How to keep your sleeping baby safe: AAP policy explained. The rule aims to reduce the incidence of injury and fatality due to unsafe sleep environments. Nychelle Fleming, CPSC spokesperson reminds parents to remove their children from these products if they do fall asleep. The FDA has never cleared an infant sleep positioner to prevent or reduce the risk of SIDS. An official website of the United States government. 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. Safety standard for infant sleep products. Infant Sleep Products Must Now Meet CPSC's New Safety Standards. Before sharing sensitive information, make sure you're on a federal government site. The FDA does not approve any products for infants to sleep in. 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. As nurses, you will see how your preemies respond to this product. The CPSC is committed to protecting consumers and families from products that pose a fire, electrical, chemical, or mechanical hazard. 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. Smart Socks were discovered to be unapproved for general distribution as well. Although some days it can feel impossible, getting enough sleep yourself can help keep your baby safe. The site is secure. The FDA has never approved any infant sleep positioner to prevent or reduce the risk of SIDS. Call CPSCs Hotline at 800-638-2772 (TTY 301-595-7054). The agency works to advance public health through initiatives that drive innovation in drug, medical device, and food science. 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. 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. Smart Socks, which the FDA discovered to be marketed to parents as a way to monitor their childrens health, did not have the necessary safety clearance, the agency stated. 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/. The Risks Of Sleep Positioners For Infants - TheEcoBaby Instead of the back, an infant should sleep on their back with no bumpers, bedding, or stuffed animals. 2005 - 2023 WebMD LLC. Outside of this, sleep positioners and sleep wedges are not recommended. How Should Babies Sleep? News release, Consumer Product Safety Commission. The FDA has advised parents to avoid purchasing Smart Socks and instead seek other methods of monitoring their childrens health. 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 other is an inclined wedge mat with side bolsters. In general, infants should sleep on their backs without pillows, wedges, comforters, or quilts. 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. CPSC and the FDA are warning parents and child care providers to: The American Academy of Pediatrics does not support the use of any sleep positioner to prevent SIDS. Deaths prompt CPSC, FDA warning on infant sleep positioners. The warmth and comfort of a sleep sack can be provided by providing a blanket without the risk of sliding on it. 4330 East-West Highway Bethesda, MD 20814, Contact Us: 800-638-2772 (TTY 800-638-8270) Baby Sleep Positioner Lawsuit | Free Case Evaluation Infant Sleep Positioners Are Dangerous - National Center for Health This can be helpful for babies who have a flat head, as it can help prevent the head from becoming misshapen. The back of your baby is a good place to sleep for a variety of reasons. 2005 - 2023 WebMD LLC. Most of the infants suffocated after rolling from a side to stomach position. Some of the best-selling baby products can keep babies from rolling and keeping them from falling asleep too quickly. 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"! Safe baby sleep positioners are devices that are designed to keep your baby in a specific position while sleeping. 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 answer is yes, and its a common question heard during the wearable blanket vs. swaddle debate. 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 . Neonatal Loving Kare specializes in developmental care products for NICU departments. At what age is sleep sacks for kids safe? Nick Blackmer is a librarian, fact checker, and researcher with more than 20 years experience in consumer-oriented health and wellness content. Please include the following information in your reports: An official website of the United States government, : %PDF-1.4 % doi:10.1542/peds.2020-035873. This surface should not contain soft objects, toys, pillows, or loose bedding. Always check with your health care professional before using any new medical product for your baby. This is a one-time FDA action, which is only applicable to the United States. CPSC is interested in receiving incident or injury reports related to these products. 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 Non-regulated products currently fill baby store shelves, each item enticing an exhausted parent to purchase it with the promise of sleep. 2-3):A newborn fall is a sudden, unintentional descent, with or without injury to the patient that results in the patient coming to rest on the floor, on or against another surface, on another person or object. 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. As a new parent, one of the biggest challenges is helping your baby sleep so that you too can get some much-needed rest. The surface of a sleeping product should not be too soft because this poses a suffocation risk. The American Academy of Pediatrics recommends that infants be placed on their backs to sleep to reduce the risk of SIDS. All rights reserved. Consumer Product Safety Commission. A health regulator in the United States has advised parents not to use them after a dozen babies died of suffocation. The victims ranged in age from 21 days to 4 months. The FDA urged parents and caregivers to talk to their child's doctor if they have questions about putting babies to sleep safely. Babies typically correct themselves if they are allowed to sit on their own. This is important because babies who sleep on their stomachs are at an increased risk for sudden infant death syndrome (SIDS). Consumer Product Safety Commission. These baby products can pose a risk of serious injury to a baby, including the risk of suffocation. "We want to make sure parents, health care professionals, and childcare providers understand the potential risk of suffocation and stop using infant sleep positioners.". Appropriate clothing keeps babies warm enough while they are sleeping. 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. . (r!Pm6ac(pD~P9Cdr.#qAeD91pA#PX C"B,BEnp98) These products are not proven to prevent SIDS. Another way to keep a baby in a fixed position is to use a sleep positioner. So we can see fewer of those injuries and fatalities that have been recently reported, says Dr. Johns of the new safety standards. Stop Using Infant Sleep Positioners, Feds Say - ABC News Most parents find that their baby outgrows the need for a positioner by 4 to 6 months old. 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. 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. Is It Safe To Use A Sleep Positioner Bed For Your Baby? Christina Johns, MD, pediatrician and medical senior advisor at PM Pediatrics says, Have I seen tragedies within my career? ET. 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 had previously cleared some infant positionersfor GERD or flat head syndrome. Is a Bassinet or a Crib Better for My Baby? 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. Swaddling restricts a childs ability to shift positions. The FDA is committed to providing accurate, science-based information to the public on the products it regulates. Infant positioning products pose a risk of suffocation, whether or not they make medical claims. Consumers can obtain this press release and recall information at www.cpsc.gov. Make sure your babys crib position is changed on a daily basis to reduce the likelihood of him having a flat head. (This intended use can be outlined by statements made on the labels, labeling, instructions for use, or promotional materials for the products.). Absolutely. In light of the new safety data, FDA believes any benefit from using these devices to ease GERD or prevent plagiocephaly is outweighed by the risk of suffocation. fda approved infant sleep positioner - theabrahamhouse.org fda approved infant sleep positioner - HAZ Rental Center Pillowing, wedges, comforters, or quilts are commonly placed beneath bassinets or cribs. 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. It is only recommended that a babys head be removed if he or she is at risk of suffocation or GER symptoms persist. 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. With a federal standard in place, parents can be more assured that sleep items for sale should meet stringent safety standards that are mandated across the country. 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. Knowing what your baby needs can be very confusing when youre faced with an array of products. CPSC.gov is an official website of the United States government. 2013;78:63019-63036. Most of the infants suffocated after rolling onto their stomachs from a side-facing position. The FDA is warning parents and other caregivers not to use infant sleep positioners because the baby may die from suffocation. This needs to be assessed on an individual basis. The device is intended to be used preventatively during sleep for infants 0-9 months of age to prevent a condition known as deformational plagiocephaly. The agency urged parents and caregivers to always put babies on their back for naps and when they go to sleep at night. Neonatal Loving Kare. Applicable products manufactured in the United States, or imported for sale in the United States, from June 23, 2022, must comply with the rule. may be regulated by the Consumer Product Safety Commission. 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 . Accept support from others, no matter how small, so you can rest. Save my name, email, and website in this browser for the next time I comment. Sleep wedge pillows and sleep positioners are out of scope for the final rule, and may be covered by Food and Drug Administration (FDA) regulations as medical devices, if they are marketed to treat a medical condition, such as acid reflux. They are designed to keep your child warm and snug, and can be used in place of traditional blankets. Neonatal Loving Kare, Inc. Transport Roll is used for transporting infants from referring hospitals via helicopter or ambulance. In general, there is no clear answer because babies are unique, and if there is any concern, consult a pediatrician. The FDA intends to take action against device manufacturers who make unproven medical claims about their products. 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. 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. 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. 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. Always put babies on their backs to sleep. The OEKO-TEX certification system is a non-profit organization that provides independent testing and certification for high-quality products. Consumer Product Safety Commission. The FDA does not approve any products for infants to sleep in. It also reduces your babys chances of developing shoulder dystocia in the second year after birth. The Smart Socks are a wearable device designed to keep an eye on a childs health. 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. 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. The AAP does not recommend using Rockn Play products that require restraint in order to allow infants to sleep. NEVER put pillows, sleep positioners, comforters, or quilts under the baby or in the crib. Prompt reporting of adverse events can help the FDA and CPSC identify and better understand the risks associated with infant sleep positioners. Table of Infant Sleep Positioner Fatalities ages 0- 23 months from January 1, 1997 to August 20, 2008 prepared by Epidemiology Hazard Analysis staff. To the untrained and tired eye, navigating the safety profile of every product is confusing and time-consuming. Some sleep positioners look like foam wedges that prop up an infants head and chest; others resemble nests or mini-cribs with side supports. The American Academy of Pediatrics (AAP) also discourages routine use of SIDS monitors. 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. 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. Sleep sacks are generally considered to be safe for babies and young children. G>vU)W)"ywAual$9RLCAuryW %N9i5+! Call our offices at 214-919-0757 or fill out our online form. 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. 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. rcDRq.0Dr$9L8QdpD;9G R:#Bai85H'h!#l@qqdx)\#q80GDcG(qeppnGdq C8P#a88'tDb&,D8n$HD}+PDp R>fB$"=DpC. LE[IVr08"8An8A'r99r. Inclined sleep surfaces should be no greater than 10 degrees. You want your child to be mobile. @!Q#.$D|DDaDDPB&N;9C9[ARC "8PAe! Nests or anti-roll supports are two types of sleep positioners. New Customer? According to the CPSC, this increased the risk of sudden infant death syndrome (SIDS). Parks SE, Erck Lambert AB, Hauck FR, Cottengim CR, Faulkner M, Shapiro-Mendoza CK. 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. 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. 13 Infant Deaths Tied to Sleep Positioners - WebMD Prevention of Newborn Falls/Drops in the Hospital: AWHONN Practice 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. lauren donovan leaving iowa; platine arrache souche; danny trevathan youngstown, ohio; merion cricket club summer membership The Loving Arms baby positioning pillow was created to comfort new born infants with reflux, colic, or NAS babies. Neonatal Loving Kare - Infant Positioning Devices & Accessories Although in the past FDA has approved a number of these products for GERD or flat head syndrome, new . You may wish to review the privacy policy of the external site as its information collection practices may differ from ours. In most cases, the infants got out of position, rolled onto their stomachs and suffocated, the FDA explained. 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. PDF Infant Sleep Positioning Products and Wedges* The federal government has received reports about babies who have died from suffocation associated with their sleep positioners. Do not use infant sleep positioners due to the risk of suffocation. (}" 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's Sharfstein said the agency has never approved a sleep position to prevent SIDS. 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. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. What do you think about using baby sleep positioners? 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. The American Academy of Pediatrics recommends that infants be placed on their . It is critical for parents to properly use sleep sacks. 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. Deaths prompt CPSC, FDA warning on infant sleep positioners According to the FDA announcement, parents should: STOP using infant positioning products. Safe Baby Sleep Positioners 2022 - Kids Decore American Academy of Pediatrics, Pediatrics, published online Oct. 17, 2011. Some babies may need one for a little longer, but most dont need one beyond 6 months. NL G|P8dYN3#(av>GDD \Va2!s{(v[dr6>>&R:t \]6 GR`2Ibi8F%|fN76WLf FDA-approved Inspire sleep apnea treatment works with your natural sleep process treating obstructive sleep apnea so you keep breathing through the night. Verywell Family's content is for informational and educational purposes only. One is a flat mat with a side bolster. Phone: (301) 504-7908 Sleeping positioners, bumper pads, blankets, stuffed animals, and other items that provide a safe sleeping environment are not permitted. Some babies have been found in dangerous positions next to a positioner they had been placed in for sleeping. 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. American Academy of Pediatrics. A number of sleep positioners are considered medical devices because of their intended use. This device gives nurses a vital tool in their daily role of repositioning and caring for these special preemies. and CPSC reviewed data on deaths related to infant sleep positioners from January 1997 to March 2011. Create a support network of friends, family, and professional help where you can. Update: FDA Warns Against Risk of Suffocation, Death with Sleep Positioners. This reduces the risk of SIDS (Sudden Infant Death Syndrome). Infant Sleep Positioners Pose Suffocation Risk, F.D.A. Says AW2OEnD0=AUiE~za$e a&#cKKB7%uD]_kA7H5JI ]-mmRl:TaUj?:T[ jZu*]$atLZ$N;KMUK^]Q/n0TKv[.U*^D{Z"RWK/8~*5t1Az3IVUK&p?UVK..mU Av_0.";vK~J6[lWpa5L(,.]R1DO#82"4OI":aFfc#GnC8,tCrdq#K']#tGG#w@D!rcGp@TmPA68 XA$ Officials say these sleep positioners should only be used by prescription. Should babies sleep on their side or at a flat angle? Both types of sleep positioners typically claim to help keep infants on their backs and reduce the risk of Sudden Infant Death Syndrome (SIDS). Are Sleep Positioners Safe? | SIDS Prevention - ChildrensMD The Owlet Smart Sock 2 is a new product that contains some features that have not been approved by the FDA. Food and Drug Administration. 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. 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. 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. According to the National Database of Nursing Quality Indicators (2016, pp. The agency asked manufacturers to stop making these products about 8 years ago, but they are still being made and sold.

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