FDA Requests Safety Measures for Topical Antiseptics
Labeling and packaging changes meant to reduce risk of infection
FRIDAY, Nov. 15, 2013 (HealthDay News) -- The U.S. Food and Drug Administration is requesting manufacturers of certain topical antiseptics make changes to their labeling and packaging that will enhance product safety, according to a Drug Safety Communication issued by the agency.
Used properly, over-the-counter antiseptics safely and effectively reduce the bacteria count on patients' skin before an operation or injection. The FDA has, however, received infrequent but ongoing reports of infection associated with the use of these products. Contamination can occur when users introduce organisms into the product.
The agency is requesting that products labeled as sterile have undergone manufacturing processes to eliminate all potential microorganisms. Contamination can still occur, however, if products are used without the proper care.
According to the FDA: "To further reduce the risk of infection with improper topical antiseptic use and the possibility of these products becoming contaminated with bacteria during use, we are requesting that manufacturers package antiseptics indicated for preoperative or preinjection skin preparation in single-use containers."