FDA Requires New Warning Label on Insulin Pens

Regulators are requiring all multi-dose pens be labeled “For single patient use only”.



Quick Hits

We’ve all seen labels that evoke the mental thought, “Well isn’t that obvious?” Examples include “Caution: Hot” on a coffee cup and “Slippery When Wet” on a wet floor. How about one for sharing insulin pens?

A recent Healio article states the FDA is mandating all multi-dose diabetes pens be labeled “For single patient use only” to prevent the spread of bloodborne pathogens. The FDA is also requiring pen instruction manuals to state pens are for individual use and should never be shared, even with a fresh needle or lancet.

Recently, Insulin Nation reported a few instances when diabetes pens were being used multiple times on different people, most notably in a case involving some 4,500 patients at the South Nassau Community Hospital on Long Island. Those patients were notified that they needed to be screened for HIV and strains of hepatitis because hospital staff used the same pen on multiple patients.

While regulators say there are no confirmed cases of bloodborne viruses being spread from pen sharing, it is often challenging to identify the source of bloodborne infections and many cases likely go unreported.

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Travis served as a staff writer for Insulin Nation and Type 2 Nation in 2015. Previously, he was a staff writer for Insight, a high school newspaper, as well as a copywriter for The Emersonian, Emerson's yearbook.