Could surgical skin preps be causing rather than preventing infections? Researchers believe the answer is yes.
Nosocomial infections associated with contaminated antiseptic products may be more common than indicated by manufacturers' reports and medical literature, according to an article by 2 FDA researchers published in the New England Journal of Medicine. Because preps aren't sterile products, produced under sterile conditions and stored as such, they're open to contamination by microbial organisms during manufacture or use.
"Users should … be aware that microbial contamination can occur when they are opening containers or diluting and storing solutions under nonsterile conditions," write the authors. "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."
Although it's difficult to assess the extent of infections associated with contaminated skin preps, outbreaks that have been reported in the literature and to the CDC have resulted in adverse outcomes ranging from localized infections at injection sites to systemic infections and death. The reports have implicated alcohol, iodophor, chlorhexidine gluconate and quaternary ammonium products, according to the authors.
In 2009, an FDA advisory committee considered whether to mandate sterile manufacturing conditions for topical antiseptic products intended for use on non-intact skin, but it didn't reach a conclusion. The agency has scheduled a public hearing for Dec. 12, and is inviting input.
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