Borchardt Consulting

Posts Tagged ‘Infant Products

Summer is here and with it comes a steady stream of stories about babies and children being left in cars with tragic consequences.  But another overheating danger is rarely discussed:.  Babies overheating in strollers. It is a common sight to see a parent pushing a stroller, with a thin blanket or towel draped over to protect the child from the sun.  Covered Stroller

Swedish newspaper, Svenska Dagbladet decided to run an experiment  to find out just how it could get inside the stroller. They left a stroller out in the sun (without baby, naturally) between the hours of 11:30 a.m. and 1 p.m. on a hot day, initially without a covering blanket. The temperature inside the stroller reached 22 degrees Celsius (71.6 Fahrenheit). A thin blanket was then placed over the stroller for the following 30 minutes, after which the temperature soared to 34 degrees Celsius (93.2 degrees Fahrenheit). After an hour, the temperature was up to 37 degrees Celsius (98.6 degrees Fahrenheit).

This experiment was done without the added heat of baby’s own body temperature increasing the temperature.  Instead of protecting the baby from the sun, the parent is inadvertently increasing the danger to the baby. Depending on the design of the stroller, the air circulation may not be the best.  Add the increase in temperature and baby can become overheated.   Overheating also increases the risk for SIDS.

 

 

Advertisements

Safe Sleep14Last year, the Consumer Product Safety Commission (CPSC) focused their efforts on creating a safe sleep environment for infants.  This year, they continue that effort by focusing on portable play yards.  As of February 28, 2013 all play yards manufactured for sale in the United States must meet mandatory federal safety standard for the first time.

Portable play yards are used by parents, home childcare providers and hotels to provide a safe place for babies to sleep when no full-size crib is available.  Therefore, it is important that portable cribs manufacturing rules be brought into safety compliance also.  The new guidelines will require:

  • Side rails that do not form a sharp V when the product is folded. This prevents a child from strangling in the side rail.
  • Stronger corner brackets to prevent sharp-edged cracks and to prevent a side-rail collapse.
  • Sturdier mattress attachments to the play yard floor to prevent children from getting trapped or hurt.

To ensure that  your baby is in the safest environment possible while left unattended, check that the date of manufacture on your play yard is February  28, 2013 or later.

Thanks to KIDS in Danger and the CPSC for all their hard work in making this new rule.

Vulnerable Babies Sleep in Pepi-Pod

The 2011 Christchurch New Zealand earthquake created an immediate crisis for the regions vulnerable newborn babies.  There was no safe place for babies to sleep.  This was seen as a public health crisis and the Pepi-Pod was born.  (Pepi means Baby in Maori.) The pēpi-pod package was quickly assembled as an emergency response to the increased risks to babies, posed by disrupted living and sleeping conditions in families, and as support for their fearful parents.  A pepi-pod is a general purpose storage box that converts to a baby sized bed with the addition of an attractive cover, fitting mattress and bedding. It offers babies a safe space when they sleep in, or on, an adult bed, on a couch, in a makeshift setting, or away from home. These are situations with a higher risk of accidental suffocation for babies.

Face Up, Face Clear

Volunteers from all over the country started sewing the covers needed for creating these pods.  Each volunteer used whatever fabric they had available. A complete package of pod, mattress, cover, 2 base sheets, 2 wrap around ‘settling’ sheets, and a double layer merino blanket for each needy family.  Blankets needed to be provided because heat was uncertain in post-quake Christchurch.   Each family receiving a Pepi-Pod received  a thorough safety briefing reinforcing the need to sleep babies on their backs with their faces clear of blankets, smoke-free environment and in their pepi-pod for every sleep.

While I have some concerns about placing these pods in the adult bed, this was a brilliant solution to an immediate public health crisis for infants.  Placing an infant in a pod such as these was certainly safer than placing them on a mattress with the entire family in post-earthquake New Zealand and best of all, to get one, the parents had to have one-on-one safe sleep training.

Some months ago, I was contacted by the Food and Drug Administration (FDA) to discuss infant products.  They had heard through their partnership with the Consumer Product Safety Commission (CPSC)  that I had been advocating for professionals to contact baby product companies when they made claims that a product would protect a baby from SIDS.   Shortly thereafter, they issued a joint press release with the CPSC that they were going to start cracking down on false claims.  I believe that has been going on in the background.  Finally, the FDA issued a warning to consumers. Claiming to prevent SIDS is a medical claim.

FDA Product Enforcement

FDA Goes after Unproven Claims

The FDA has never cleared or approved a baby product to prevent or reduce the risk of SIDS. The Agency is not aware of any scientific studies showing that a medical device prevents or reduces the risk of SIDS.

Examples of common over-the-counter baby products with unproven claims to prevent or reduce the risk of SIDS include:

  • baby monitors,
  • mattresses,
  • crib tents,
  • pillows,
  • crib bedding, including bumpers and blankets, and
  • infant positioners.
Recently, the FDA has improved on our idea.  They have developed a way for consumers and professionals to report a product.  See their instructions listed below.

How to Report a Complaint or Problem

Report a Complaint

If you have questions or complaints about a baby product with medical claims, you can call FDA at 1-888-INFO-FDA (1-888-463-6332) or your local FDA district office. They will be able to tell you if the FDA has cleared or approved the medical device in question.

Report a Problem

If you experience an injury or malfunction when using a baby device, 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.

Please include the following information in your reports:

  • Manufacturer’s Name
  • Device Name (Brand Name)
  • Date Device was Manufactured
  • Distributor’s Name
  • Details of Adverse Event and Medical and/or Surgical Interventions (if required)

I am thrilled at this new move!  Thank you FDA!

Along with many partners, we were successful this year in getting the toughest new crib standards passed in the world.  Now, it’s time to turn our attention to portable play yards.  In Illinois, Childcare providers can use portable play yards as an infant crib.  It’s essential that we create the best standards for this piece of equipment as well.  Cribs and play yards are the only place that we leave infants unattended for hours at a time, it’s critical that parents and caregivers know that they have the best, safest piece of equipment available.

 

Play Yards: What Parents Should Know.


Enter your email address to subscribe to this blog and receive notifications of new posts by email. Your email address will not be used for any other purpose.

Join 299 other followers

Safe Sleep Baby

Miss an Article?

Advertisements
%d bloggers like this: