Borchardt Consulting

Posts Tagged ‘FDA

SIDS has been every new parents nightmare since biblical times.  No more.  Parents now have the tools to keep  their babies safe. The goal to keep baby safe begins when you’re pregnant.

  1. Moms get early prenatal care.  See your doctor often when pregnant.
  2. Create a healthy lifestyle while pregnant.
  3. Don’t smoke while pregnant or let anyone smoke around you and your baby.
  4. Don’t drink or use drugs while pregnant.
  5. Plan to breastfeed as long as possible.

Getting the nursery ready is simplier than ever.  Remember, less is more.  Decorate the baby’s room.  Not the baby’s crib.  All you need is a safe crib, a firm mattress (read hard) and a fitted sheet.  That’s it.  Your crib should be manufactured after June 28, 2011 to ensure that it meets all the latest safety guidelines.  This is a place that you will leave your baby unattended for hours so don’t cut corners here.  Don’t borrow an old crib or buy one at the second hand store.  If you plan to use a portable play yard as your baby’s crib, there are new safety standards that will go into effect December 2012.  Place the crib in your room for the first 6 months of baby’s life.

Unsafe Crib

Unsafe Crib

Bumpers, quilts, pillows and stuffed animals should never be in baby’s crib.  They are all too soft and fluffy for an infant. and they pose a suffocation hazard for your baby.  When your baby is old enough to be put in the toddler bed, you can start allowing soft items.  Recently, the Juvinille Products Safety Commission admitted that it could not show any proof that bumpers keep a baby safe from getting arms or legs stuck in the crib slats nor could they prove that bumpers keep baby safe from head injury.  Unfortunately, the Consumer Product Safety Commission and SIDS researchers can prove that bumpers have been directly responsible for the deaths of some infants.  They may be cute, but the are not worth the risk to your baby.

After baby is born, just a few more simple behaviors for parents:

  1. But baby on his or her back alone in the crib.
  2. Use a pacifier after breastfeeding is firmly established for sleep times.
  3. Do not cover baby’s head with hats or blankets.
  4. Put baby in a wearable sleep sack or feetie jammies rather than using blankets.
  5. Swaddle baby if needed, but only up to 6 weeks…and remember to dress baby lighter since you hold in body heat with the blanket.
  6. Get baby all recommended vacinnations.
  7. Never put baby on an adult surface like a couch or adult bed to sleep.

That’s it! You have all the tools needed to keep your baby safe from both SIDS and other sleep related deaths.  Oh, don’t forget that baby needs good tummy time when awake for proper development.  Enjoy your baby!

For more tips, follow me on Facebook.

 

Advertisements

The FDA continues to talk about the dangers of sleep positioners and other products that make specific claims to “prevent SIDS”.   At first glance, it seems like an over-reaction to a small number of accidental suffocation deaths – 13.  However, the number is actually much higher.  Unfortunately, many babies die with unsafe products like bumpers and positioners in the crib with them, but those deaths are not reported to the Consumer Products Safety Commission (CPSC) or the Food and Drug Administration (FDA) because the product has been considered “normal” in the babies crib environment.

Despite the warnings, many parents continue to use these dangerous comforts.  Many parents equate “softness” with “comfort” and inadvertently put their babies at risk.

See Video

 

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!


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

Error: Twitter did not respond. Please wait a few minutes and refresh this page.

Miss an Article?

Advertisements
%d bloggers like this: