(HealthDay News) – Recent reports linking outbreaks of infection to antiseptic products have prompted the U.S. Food and Drug Administration to evaluate the need for sterile manufacture of such products, according to a perspective piece published in the Dec. 6 issue of the New England Journal of Medicine.

Christina Y. Chang, MD, MPH, and Lesley-Anne Furlong, MD, from the Center for Drug Evaluation and Research at the FDA in Silver Spring, MD, discuss the outbreaks associated with the microbial contamination of antiseptic products, including outbreaks which resulted in product recall.

The authors note that reported outcomes vary, from localized infections at the sites of injection to systemic infections which potentially result in death. All commonly used antiseptic categories have been implicated in reports: alcohol, iodophors, chlorhexidine gluconate, and quaternary ammonium products. Potentially pathogenic organisms, including Bacillus cereus and Pseudomonas aeruginosa, have been implicated in multiple outbreaks. Contamination may occur during manufacturing or by end user manipulation; user awareness could reduce the likelihood of contamination. It is unclear how long containers can remain safe from contamination after being opened. The FDA is currently evaluating the issues pertaining to a requirement for 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,” the authors write. “The isolation of unusual organisms (eg, Bacillus cereus) after the use of topical antiseptic products should trigger an investigation of possible contamination stemming from an antiseptic product.”

Full Text