July 01, 2019

In the wake of infant deaths linked to the Rock 'n Playtm  inclined sleeper our Legislators and the Consumer Product Safety Commission (CPSC) are considering changes needed to improve product safety.  Taking these actions is to be expected.  It's also an opportunity for a new approach.

Let's encourage the CPSC to adopt some of the best practices from the FDA's Medical Device Reporting (MDR) requirements.  While not completely foolproof, the MDR process places more accountability on manufacturers to track and report adverse events.  The FDA program requires when needed, manufacturers to quickly fix product issues that have caused substantial harm.  The MDR process also allows customers to submit product safety issues and report adverse events voluntarily.  

The medical device and consumer baby product markets are very different, especially concerning manufacturing, safety, and compliance.  A majority of medical devices used in the US are American made while China manufactures most of our consumer baby products.  Additionally, the creation of product safety requirements for infant products can be more influenced by manufacturers than by the standards for medical devices. Tracking, reporting, and documentation requirements are also significantly higher for medical devices.  Many baby product manufacturers would object to an MDR like system emphasizing increased costs and administrative burdens.  If adopted, many would then pass on the costs to consumers. However, the best manufacturers would realize the benefits and end up building safer products.  Perhaps we would begin to see the return of baby products made in America.

We make our Prapela SVS baby box in the US from domestic and carefully sourced international parts.  We also use systems and methods required of medical devices, not consumer products.  For example, we meet the FDA requirement for a "tracked device" with a unique serial number linked to the contact and address for every product we ship.  Most consumer baby product companies rely on customers registering their products, and many are without unique serial numbers.

The infant deaths linked to Fisher-Price make it self-evident the existing CPSC program is not effective in either reporting or taking corrective actions fast enough to save lives.  Infant product manufacturers need to step up and increase their diligence and reporting.  It's time for a new approach from the CPSC.  Our children are worth it.

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