SafeSleep Blog infant sleep products and testing

Sleep Products for Infants; is yours safe?

Are your infant’s sleep products safe?  Most parents believe if a product makes its way to the shelves of big box retailers and etailers, it must be safe.  The grim reality is many are not.  We have seen one recent example, the Fisher Price Rock and Play and other inclined sleep products causing hundreds of infant deaths.

As a SIDS and Safe Sleep content expert, I have been privileged to the juvenile product industry standard’s flaws when it come to safety of infant sleep products.

CPSC & ASTM

The Consumer Product Safety Commission (CPSC), who works closely with the ASTM (formerly known as American Society for Testing and Materials), has a  sub committee on infant sleep products.  The issue is, this committee is made up predominately of sleep product manufacturers.  And the ASTM physician on the committee, wants thousands of well documented deaths before “risking” making product mandates for infant sleep products.

Background

Over ten-years-ago, I challenged an industry standard and made drastic changes to the traditional crib mattress design.  I was fortunate; I had a pediatrician (who is also a mother of four) acting as a free consultant while I was in the design phase of my air permeable/breathe-through crib mattress.  She  offered me both professional and practical advice and introduced me to many prominent players in the medical community.  She has many professional connections through her decades of service as a Committee Chair Member of one of the American Academy of Pediatrics (AAP) sub committees. 

We both lost a loved one to positional asphyxiation, classified as a SIDS death.  Product safety and testing for my design was paramount.  Without her connections, I believe finding the proper testing methods and scientific data to create a product that we could prove is safe, would have proven difficult. 

Testing requirements

The sad reality is infant sleep products do not require much testing at all.  Infant sleep products must meet flammability requirements which often results in adding harmful chemicals to fiber and foam filled products.  And if you want to call yourself a “standard size crib mattress,” you must conform to size requirements, and that’s it.  The CPSC asks that you use proper labeling of your fiber content, but it’s not mandatory.

The lack of standards and available testing methods makes it difficult for manufacturers to know if their sleep products are truly safe, let alone consumers.  So, who is responsible for unsafe infant sleep products making their way into the homes of unsuspecting consumers?

Infant’s spend 70% of their first year sleeping.  The safest thing all parents should own is a sleep product.

No easy task

It was no easy task, but we were determined to keep safety and testing as our two main criteria for our new design.  Once we identified all the risks associated with conventional crib mattresses and infant sleep products, we had to search for medical professionals willing to test our product.  Some tests didn’t even exist.  We had to convince a few medical professionals to develop testing.   

We needed to make sure our infant sleep product not only conformed to the few current regulations in play, we needed to make sure it conformed to the AAP’s Safe Sleep Policy Recommendations.  This was no easy task finding testing available to make this possible.  The AAP was just about to publish their 2011 Safe Sleep Policy, so we found out as much as we could about updated recommendations.  There were no new updates for crib mattresses.  The AAP continues to recommend a firm crib mattress with a tight-fitting sheet even though there is no test data to support a firm crib mattress with a tight-fitting sheet as being safe. 

Testing versus retrospective analysis

When I say there is no test data, I mean there is no gold standard testing where babies are placed on different types of crib mattresses to see which ones will survive on a certain type of crib mattress and which ones will not.  As you can see, this type of testing would be unethical.   The closest testing of this type was done by Dr. James Kemp who used baby bunnies.  The AAP Safe Sleep Task Force members must go by what is called retrospective analysis.  This means, the best data they have is to sift through thousands of infant death reports and find correlations of infants in a certain age group, gender, weight, etc.. and try to determine why some infants lived and others died.  For example, let’s take the “back-to-sleep” recommendation.  These scientists found that infants fitting similar profiles were more likely to die if they were on their tummy while sleeping than on their back.  The recommendation for a firm crib mattress is based on infants dying on soft mattresses.

Inherent flaws

Retrospective analysis data can often be flawed and it is subject to interpretation by the scientists.  Death scene investigations are not always standardized.  There is a significant effort in this direction, but we are not there yet.  It is up to the medical examiner or pathologist to determine the cause of death and take notes on the series of events and the scene.  You can have two examiners look at the same scene, and their is a high probability one examiner will include certain data and exclude data the other examiner would not.

Firmness testing

Even though the AAP recommends a “firm” crib mattress or sleep surface based on death scene investigations, no standard for firmness in the US exists.  More importantly, there is no available firmness testing.  There is also no testing available to determine if a sheet is safe or not.  According the most recent AAP safe sleep recommendations, a sheet that is designed for the mattress you are using is recommended.  The issue is, crib mattress manufacturers are not the ones manufacturing sheets.  There are no clear guidelines for consumers to ensure they are buying the proper sheets for their particular mattress.

We were not concerned about sheet testing since our products do not use them.  We knew they have been linked to many strangulation deaths, so they were out for our design.

However, we were interested in making sure our products met firmness standards.  I happened to e-meet a doctor on a SIDS infant list serve who is a child product safety expert in Australia, Dr. Ron Somers.  Dr. Somers developed a test to measure crib mattress firmness and established a standard in Australia and New Zealand.  Not only did he test our mattress free of charge, he helped get them into multiple child-care facilities in Australia.  He also gave our product an unsolicited endorsement

The point is the firmness test was not available in the US.  We had to ship our product to Australia to have it tested. 

Asphyxiation – airway blockage & rebreathing

Our next big safety concern with conventionally designed crib mattresses was the risk of asphyxiation.  Asphyxiation is two-fold in reference to crib mattresses and other sleep products. 

First, there is asphyxia, commonly know as suffocation, when airways are blocked.  A soft fiber-filled mattress or a quilt would be perfect examples of how an infant’s airways could become blocked if face into them.

Second, asphyxiation can occur if an individual continues to rebreathe their exhaled air (carbon dioxide). SIDS experts believe carbon dioxide rebreathing is a common risk factor associated with infant sleep related deaths. It’s believed some infants do not respond by turning their heads when rebreathing their exhaled air.  If an infant rebreathes their carbon dioxide without responding, the carbon dioxide eventually suppresses their need to breathe, making it lethal.  To reduce the risk of carbon dioxide rebreathing, the American Academy of Pediatrics recommends a firm crib mattress, placing baby on their back, no bumper pads, no quilts or blankets, no mattress pads, no sleeping on couches, or sleeping with others, and not allowing a baby to sleep on you.  Some of these recommendations have multiple risks.  For example, co-sleeping is a risk for carbon dioxide rebreathing and overlay/suffocation.    

New products being targeted

We are currently seeing another product being sold in the infant sleep product category that seems to be causing concern with many medical professionals, the Dock-a-Tot.  One pediatrician mommy blog site that warns parents against the product is PediMom.com.  In a recent Facebook (FB) post by PediMom she states,

“I have coded and lost infants due to this contraption. We advocate for no bumpers, right? This is like several big fluffy bumpers placed even closer to your child’s face which increases their risk of suffocation and death.” 

She goes on to say,

“Don’t come at me with, “I only let my baby lounge in it, not sleep in it”. Infants fall asleep in the blink of an eye and NO PARENT can have their eyeballs on their child 100% of the time. It’s impossible and if you’re honest you’ll admit that.”

Another FB pediatrician I follow is Dr. Diane Arnaout.  I love her no-nonsense approach.  Here is her FB message to her followers regarding the Dock-a-Tot,

“I know. I know. You guys love them. You put your baby in bed with you. You feel like they have their own sleep space. The baby feels nestled and cozy. Yay sleep. All is well.  Until your baby turns his sweet little head to the side. Maybe even his body nestles to the side. Maybe his face presses into the “breathable” material. Maybe he breathes comfortably here for awhile.  The air in that little space by his face is breathed in, and out. Oxygen goes in, carbon dioxide goes out. Slowly, there is more exhaled carbon dioxide in that little space than there is oxygen.  What most parents (and even medical professionals) don’t realize is that CARBON DIOXIDE REBREATHING is something researchers believe contributes heavily to sudden infant death. “

She continues on to say,

“The U.S. Food and Drug Administration (FDA)  has begged parents not to use them and manufacturers to stop making them since 2010: https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm227575.htm

From a manufacturer

As a manufacturer, I understand that you can create and produce just about anything for infant sleep and it requires virtually no oversight or testing.   I also understand many manufacturers are more interested in the bottom line than they are in safety.  Until stricter regulations, structured testing, and accessible testing methods are available, we will continue to lose innocent lives to eventually prove an infant sleep product is unsafe and should never have been sold to consumers.

SafeSleep is our manufacturing company, and our mission is not only to deliver safer, healthier, more sanitary crib mattresses to families, it is also to lobby for change in safety regulation and testing.  We hope to one day see both carbon dioxide dissipation testing and firmness testing mandated for all infant sleep products.  If you would like to learn more about our Company and story, please visit https://www.abcsafesleep.com

You may also be interested in our successful efforts in influencing changes to the 2016 AAP Safe Sleep Policy and technical report.  https://www.globenewswire.com/news-release/2016/11/14/889732/0/en/Two-Michigan-Women-Influence-Changes-to-the-2016-Safe-Sleep-Policy.html

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