Have you ever wondered which type of children's product has the longest history? As far as children's sleeping products are concerned, the bassinet is probably the most time-honored staple. Iron baby beds were developed in Italy in the 17th century to prevent against the infestation of bed bugs and moths. In fact, there is evidence of a rockable iron bassinet with spear-like corner posts dating back to 1620-1640.1 The style of bassinet with which we are familiar today came into fashion before the 19th century for the specific purpose of raising sleeping infants off the ground. At that time, it was believed that noxious fumes existed at ground level below knee height, and explosive vapors existed near the ceiling. It was important that babies could breathe the good air in between, which meant positioning them several feet above the floor but not too close to the ceiling.2 Once a child could stand on his or her own, a safety concern arose with bassinets because there was a risk that the child could climb out of them and fall. Therefore, infant beds with higher sides were developed in the 19th century for children 12 months old and older, eventually leading to our current version of the crib.
As with many types of baby sleeping devices, bassinets have historically been reused multiple times with multiple children. This can lead to a single bassinet being used for decades, during which time safety features and standards may have been developed that render the product obsolete. The extended use of these products has led to various risks associated with the use of bassinets, including fall hazards, choking or entanglement hazards, suffocation hazards, and risk of injury due to the product tipping.
To address many of these concerns, the U.S. Congress passed the Consumer Product Safety Improvement Act (CPSIA) in 2008, which requires mandatory federal standards for over a dozen durable juvenile products.3 Specifically, Section 104 of the CPSIA gives the Consumer Product Safety Commission (CPSC) authority to promulgate mandatory safety standards for durable infant and toddler products. The mandatory standards established by the CPSC may be substantially the same as any current voluntary consumer product safety standards for such durable products (such as voluntary standards established by ASTM International), or may be more stringent than the voluntary standards, if the CPSC determines that a stricter standard would further reduce the risk of injury. The passage of the CPSIA marked Congress's recognition that consumer confidence in children's products would increase if safety standards were mandatory, and that every child should be safe while sleeping.
While there are many different types of child sleeping devices, such as cribs, play yards4 and bedside sleepers, this article will focus on the current and proposed regulations related to bassinets.
What is a bassinet?
A bassinet, like a crib, is used as a sleeping choice for various ages of babies, especially newborns. A bassinet, however, is typically much smaller than a crib and usually has some portability feature that allows it to be moved. Bassinets also typically have lower sidewalls than cribs, which allow parents to more easily place their sleeping baby inside the product. Finally, bassinets usually have some type of hood or cover that can be pulled over the baby while he or she is sleeping.
For regulatory purposes, a bassinet encompasses a product "primarily intended to provide sleeping accommodations for an infant up to approximately [five] months in age or when [a] child begins to push up on [his or her] hands and knees, whichever comes first."5 However, it does not include inclined infant swings, strollers or inclined sleepers. More specifically, the standard defines a bassinet as a "small bed designed primarily to provide sleeping accommodations for infants, supported by free standing legs, a stationary frame/stand, a wheeled base, a rocking base, or which can swing relative to a stationary base" and, "[w]hile in a rest . . . position, . . . [it] is intended to have a sleep surface less than or equal to" ten degrees.6
Current regulations governing bassinets
Pursuant to Section 104 of the CPSIA, the CPSC passed a regulation requiring mandatory consumer product safety standards for bassinets in 2013. See, 16 C.F.R. § 1218, et seq. This regulation and accompanying standard applies to all bassinets manufactured or imported into the U.S. on or after April 23, 2014.7 The purpose of the regulation is to "minimize the risks of incidents to an infant resulting from normal use and reasonably foreseeable misuse of a bassinet . . ."8 The mandatory safety standard for bassinets is derived and incorporated from the ASTM F2194-13 voluntary standard.9 This standard provides consumer product safety specifications covering structural and performance requirements, mandatory test methods, and product marking requirements to promote safe use of bassinets. The structural requirements for bassinets set forth in 16 C.F.R. § 1218 are broken down by the following categories:
- lead limits in paints
- sharp edges or points
- small parts
- wood parts
- scissoring, shearing, or pinching
- unintentional folding
- corner posts
- bassinet accessories to play yards and/or other non-full-size cribs
- occupant restraint systems
Bassinet performance requirements mandated by 16 C.F.R. § 1218, which incorporate provisions of ASTM F2194-13, are categorized by the following:
- spacing of rigid sided bassinet components
- openings for mesh/fabric sided bassinet
- static load
- sleeping pads
- protective components
- bassinets with segmented mattresses
- fabric sided enclosed openings
- rock/swing angle
- removable bassinet bed attachments
Some of the safety measures required for bassinets under 16 C.F.R. § 1218 include the following:
- uniform slat spacing to prevent entrapment
- mesh and fabric openings that do not entrap fingers, toes, or buttons
- a static load test to check structural integrity, including the integrity if a large child is inside
- stability tests to see if a product can be tipped over by a toddler
- sleeping pad thickness and dimension requirements to reduce the risk of entrapment in gaps or suffocation due to extra padding
- locks and latches that are tested to prevent accidental folding
- warning labels that address the risk of suffocation when extra bedding is added
- rocking and swinging that is limited to prevent a child from being pressed into the side
- side height requirements to prevent falls
- segmented mattresses that must be flat enough to prevent suffocation in its folds
While the foregoing list provides a brief summary of the mandatory safety requirements for bassinets sold in the U.S., it is important for manufacturers and sellers of bassinets to understand and comply with all of the requirements set forth in 16 C.F.R. § 1218.2.
Proposed updates to bassinet regulations
A proposed rule relating to certain bassinets was issued by the Food and Drug Administration (FDA) on October 8, 2015.10 While it may seem unusual for the FDA to issue a proposed rule for a consumer product, which is generally the territory of the CPSC, the FDA will become involved with children's and other consumer products if the product is used in healthcare or can otherwise be deemed a medical device. The FDA's proposed rule regarding bassinets specifically deals with those devices used for pediatric medical purposes. The CPSC's standards for cribs were modified on December 28, 2012 to ban drop-side rail designs for consumer cribs used in childcare centers, family childcare homes, and places of public accommodation. The FDA, on the other hand, still regulated medical cribs and bassinets used in healthcare settings and allowed such devices to have the drop-side rail features. At the same time, the FDA noted that certain situations require pediatric medical cribs and bassinets with drop-side rails to be used outside of the healthcare setting.
The need for pediatric medical cribs and bassinets in homes and other places eventually evolved into current proposed rule. However, the FDA noted that certain risks are still apparent with drop-side rail features, which include injury resulting from mechanical or structural failure of the device; pinching, laceration, splinters, and foreign body ingestion; entrapment, falls, and strangulation; burns; and user error.11 In order to provide for the needs and confront the associated risks, the proposed rule addresses elements for pediatric medical cribs and bassinets that include:
- new safety requirements for such products used in the treatment and care of sick children, which would allow them to use such devices outside the healthcare setting when prescribed by a doctor
- slat width and mattress flammability standards consistent with the requirements promulgated by the CPSC for cribs and bassinets
- separate safety requirements for pediatric hospital beds (which include both cribs and bassinets used for pediatric medical purposes)12
The purpose of the proposed rule is to:
- provide continued access, by prescription, to pediatric medical cribs and bassinets with drop-side rails in a home, childcare, or other facility when medically necessary
- further reduce potential risks associated with pediatric medical cribs and bassinets, such as entrapment or fire
- align applicable safety requirements for pediatric medical cribs and bassinets with those of cribs and bassinets for non-medical use
- provide manufacturers with clarity about the FDA's safety expectations and requirements by providing more specific design requirements for pediatric medical cribs and bassinets13
The comment period on the FDA's proposed rule for pediatric medical bassinets closed on December 7, 2015, with eleven (11) comments received by the FDA.14 No further action has yet been taken regarding this proposed rule.
Newborn babies have been sleeping in bassinets for centuries, and understandably the bassinet has evolved substantially over time. The current 16 C.F.R. § 1218, which was passed into law in 2013 and is based on voluntary standard ASTM F2194-13, provides warnings, test methods and safety requirements that all manufacturers and sellers of bassinets must adhere to before selling any such product in the U.S.
Since the adoption of this mandatory standard relating to bassinets, the FDA has filed a proposed rule regarding bassinets and cribs that may be used for pediatric medical purposes. This proposed rule is currently pending. Even if a manufacturer or retailer of bassinets does not market its product for use in medical or healthcare settings, it is important to be mindful of all current regulations regarding bassinets set forth in 16 C.F.R. § 1218, as well as any rule that may be issued by the FDA for pediatric medical bassinets (since such devices may be used in the home or outside of a healthcare setting if prescribed by a physician). It is also important for manufacturers to be aware of ASTM F2194-16e1, which was updated this year and provides the most current voluntary standards related to bassinets.