Report Warns: Be Aware of Potential Contamination of Antiseptic Products

Reports published in the last few years have linked infections to antiseptic products that were contaminated with microbial organisms, according to a report in the New England Journal of Medicine.

Antiseptic drug products can be used to prepare skin prior to surgery or prior to an injection, among other uses. While it is often assumed that the nature of antiseptic products prevents them from becoming contaminated, reports in journals and to the CDC have indicated otherwise. These reports have showed that infections can be tied to all antiseptic categories, including alcohol, iodophors, chlorhexidine gluconate and quaternary ammonium products, according to the New England Journal of Medicine report.


Topical antiseptic products may become contaminated with microbial organisms during manufacturing or during manipulations by the end user, such as from dilution of the product with nonsterile water or from storage in nonsterile containers. The authors suggested healthcare providers should be aware of the potential for contamination to prevent infection.

The FDA first considered whether to require topical antiseptic products be manufactured under sterile conditions in August 2009. The FDA is holding a public hearing on the subject Dec. 12 and 13 to discuss the topic further.

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