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A new diaper product does quite a bit more than what diapers have always done. Smart Diapers by Pixie Scientific, N.Y., N.Y., monitor for signs of a health issue, such as a urinary tract infection, dehydration or developing kidney problem. Using a smart phone, a parent can scan the QR code patch on the front of a baby’s wet diaper for an almost instant report.
The product also tracks a child’s health for months or years, automatically looking for emerging trends or patterns.
Kidney problems, for example, can develop for multiple reasons: premature birth, an infection, undiagnosed diabetes, etc. Typically, observable symptoms don’t show up until several years after a problem’s already begun. The Smart Diaper looks for early signs to make sure children who require diagnosis, monitoring or care will receive it before the observable symptoms set in.
For children who have already been diagnosed with a chronic kidney condition, Smart Diapers make a parent’s job easier by providing an instant and on-going analysis of information. For researchers, the data collected could become a useful tool.
Smart Diapers and Pixie Briefs contain reagents that interact with leukocytes (cells made by the immune system) and nitrites (byproducts of bacteria). They also have reagents that measure electrolyte concentration (a measure of hydration), and pH (alkalinity). These reagents react with urine and produce measurable color changes. They are not toxic and they do not come in direct contact with the skin, but are incorporated into the outermost layer of the diaper or brief, over the absorbent core and the inner liner.
The company says their goal is to create a product that is unobtrusive in daily life and only “speaks up” when there is a reason to see a pediatrician or specialist.
Although diapers are not subject to FDA (U.S. Food & Drug Administration) regulation, Smart Diapers and Pixie Briefs are subject to FDA regulation because they’re intended to help in urine. The company is working with the Office of In-Vitro Diagnostics at the FDA to design a trial for 510(k)-based approval.