Topical Antiseptic Products Could Harbor Microbial Stowaways

Antiseptic drug products fall into one class of drugs that was included in the regulations, since at the time, it was assumed that antiseptic drug products were free of microbial contamination because of their pharmacologic activity. The need for sterile manufacture for these products was therefore not considered.

In recent years, however, there have been published reports linking outbreaks of infection to antiseptic products that were contaminated with microbial organisms. The reported outcomes ranged from localized infections at injection sites to systemic infections resulting in death. The reports implicate all commonly used antiseptic categories. Some potentially pathogenic organisms, such as Bacillus cereus, Burkholderia cepacia, Pseudomonas aeruginosa, and Serratia marcescens, have been implicated in more than one outbreak.

The contamination of the antiseptic drug products may occur either during manufacture (intrinsic contamination) or during manipulations by the end user (extrinsic contamination), such as dilution of the product with nonsterile water or from storage in nonsterile containers or conditions, since the period during which a container, once opened, can remain safe from extrinsic contamination is unknown. Awareness on the part of users may reduce the likelihood that multidose antiseptic products will become contaminated. The study was published in the December 6, 2012, issue of the New England Journal of Medicine (NEJM).

“The FDA is continuing to evaluate the issues surrounding a requirement for the sterile manufacture of antiseptic products. It is important that health care providers be aware that topical antiseptic products, if contaminated, pose a risk of infection and that particular microbes isolated from clinical specimens have been traced to the contamination of such products,” concluded study authors Christina Chang, MD, and Lesley-Anne Furlong, MD. “The isolation of unusual organisms after the use of topical antiseptic products should trigger an investigation of possible contamination stemming from an antiseptic product.”

Several factors may limit the identification of infections related to antiseptic products. Health care providers may not consider these products as a potential source of postprocedural infection, because they assume that antiseptic properties preclude microbial survival. Cases of contamination might be underreported, since epidemiologic investigation and infection workups require a high index of suspicion on the part of the treating clinician. In addition, single-use containers are typically discarded at the conclusion of a surgical procedure, so the residual product may not be available for investigation when an infection becomes apparent.

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US Food and Drug Administration