Skip to content

FDA Hearing – Antiseptics Can Actually Cause Infections

by Joshua A. Green, JD, MPH on December 7th, 2012

The Food and Drug Administration announced that it is holding a two day public hearing on a rather ironic issue: the microbial contamination of antiseptics. Surprisingly, some antiseptics used to prevent infections are actually the cause of some infections.

When the FDA developed regulations in the 1970s for a number of drugs that were on the market but had not yet received FDA approval, it based the standards for evaluating antiseptic efficacy on the reduction in bacterial counts on a patient’s skin after application. The FDA assumed that, because the pharmacological purpose of antiseptics was to destroy bacteria, antiseptic drug products were free of microbial contamination. Thus, no regulations concerning the sterility of the antiseptics or their packaging were established.

Since antiseptics first received FDA approval, the FDA has learned that bacteria can contaminate antiseptic products at the time of manufacture or use. Using contaminated antiseptics on patients’ skin has been associated with clinical infections and outbreaks. Reports implicate all commonly used antiseptic categories. The FDA, in its public hearing, is seeking input on how to address this issue.

For more information concerning the microbial contamination of antiseptics see Microbial Stowaways in Topical Antiseptic Products published yesterday in the New England Journal of Medicine.

Share and Enjoy:
  • Twitter
  • Facebook
  • Google Buzz
  • LinkedIn
  • Google Bookmarks
  • email

From → Misc.