Infant Sleep Products: Shouldn't All the Data Matter?

This week, organizational psychologist and bestselling author, Adam Grant, tweeted:

Overthinking is a problem.

Underthinking is a bigger problem.

 

I feel sorry for people who get stuck in analysis paralysis.

I worry about people who don’t do the analysis in the first place.

 

It’s better to embrace the discomfort of doubt

than to live with the regret of overconfidence.

On June 2, 2021, the Consumer Product Safety Commission (CPSC) voted to require flat infant sleep products that do not fit into one of five product categories for which there are mandatory safety standards (full and non-full-size cribs, play yards, bassinets, bedside sleepers) to meet the requirements of the bassinet standard. For many of the affected products, like baby boxes and in-bed sleepers (IBS), this requirement is tantamount to a pre-emptive ban.

The Commission’s decision was pitched as a win for baby safety. This sounds great; however, the evidence does not support this conclusion. Portable, flat infant sleep products offer important safety benefits for infants, and the data specific to these products does not support the contention that they are “dangerous”.

Take baby boxes, for example. These products have been used in the U.S. and around the world for decades without a single death. Baby boxes are inexpensive relative to a bassinet, crib or play yard; they are also smaller and more portable and therefore have great utility for caregivers living in small dwellings and those who wish to room-share, as advised by the American Academy of Pediatrics (AAP). To comply with the bassinet rule, baby boxes will be required to have a stand. A stand does not make baby boxes safer, but it does make them more expensive, less transportable, have a larger footprint, and therefore, less usable for those with a limited income and living space. As such, this rule particularly disadvantages consumers with limited financial resources.

In-bed sleepers are used by caregivers who bedshare with their infants. Bedsharing is practiced by the majority of U.S. mothers, either full-time or occasionally. One of the main reasons for bedsharing is to facilitate breastfeeding, which is SIDS-protective. Bedsharing also promotes maternal-child bonding and allows for better sleep. Despite these important benefits, bedsharing also presents a risk of asphyxiation due to overlay. The Commission recognizes this, but fails to distinguish the overlay risk when bedsharing versus when using an in-bed sleeper. While the agency’s own data shows more than 100 infants die of asphyxia due to overlay when bedsharing each year, there are no overlay deaths associated with any brand or style of in-bed sleeper. Aside from the CPSC’s data, published research of native in-bed sleepers, called “wahakura” and “pepi-pods”, used with at-risk mothers and infants in New Zealand as part of a safe sleep program, also found no overlay deaths. Further, it was determined that these products do not increase other risks. Thus, in-bed sleepers potentially serve as an important safety device for bedsharing parents; however, these products will disappear as a result of this rule.

In the Final Rule, the CPSC failed to acknowledge not only the utility of these products, but also the negative impact such a rule could have on at-risk consumers and those with limited financial and other resources. With these smaller products off the market, consumers who cannot afford the cost or space of a conventional product will undoubtedly fill this void by bedsharing with the baby directly on the mattress (a known overlay risk), or improvising with home-made products or makeshift barriers of pillows or rolled-up blankets (known causes of infant suffocation). CPSC Staff’s rationale that at-risk consumers would benefit greatly from adhering to AAP’s safe sleep guidance, and from a Final Rule that facilitates those recommendations, may be true in theory. But simply telling mothers not to bedshare will not cause them to stop. Such a recommendation ignores the cultural underpinnings of bedsharing and is refuted by published research on this very issue.

Protecting infants from dangerous products is the CPSC’s mission and the objective of everyone working in product safety. Doing so must be guided by objective analysis of the data. While the agency’s decision to support the rule is undoubtedly well-intended, it is not supported by available data on fatalities and consumer behavior. Rather, the Final Rule is based on anecdotal information, general statistics that are unrelated to the subject products, and data on unrelated inclined sleepers.

Rather than banning entire classes of portable, flat infant sleep products with known safety benefits, which this rule does, the Commission should support on-going ASTM standards for these products. Standards allow products to retain their unique benefits (safety, accessibility, affordability, size, etc.) while imposing stringent performance requirements that address safety concerns. This may cause some product designs to require modifications; that is okay and a part of the standards development process. In my opinion, supporting standards for portable, flat infant sleep products is a sounder path, likely to result in far better safety outcomes, than simply banning these products.

Without a doubt, the CPSC endeavors to reduce infant deaths in sleep products. However, winning the battle for safe infant sleep requires a critical evaluation of all of the data, as well as avoiding unintended consequences of agency action. Doing so is not “paralysis by analysis”; rather, it is a key part of effective product safety regulation.