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Deaths, Injuries Prompt FDA Appeal for Topical Antiseptic Package, Label Revise

Nov 14, 2013

Label and packaging changes have been requested by the U.S. Food and Drug Administration (FDA) for some over-the-counter (OTC) topical antiseptic products stemming from infection concerns.

The request follows an ongoing agency evaluation of what the FDA described as “infrequent but continuing” infection reports associated with antiseptic products labeled for pre-operative or pre-injection skin preparation.

When the topical antiseptic products are properly used, they are a safe and efficacious way to reduce bacteria on patients’ skin before surgery or injections. Contamination occurs when users introduce organisms into the OTC topical antiseptic. Because of this, says the FDA, healthcare professionals and patients should carefully follow label directions to reduce the likelihood of infection.

Outbreaks tied to use of contaminated topical antiseptics have been reported in medical literature, as well as to the U.S. Centers for Disease Control and Prevention (CDC). Clinical infections have also been reported to the FDA, which has led to some product recalls.

Reactions have included a range of outcomes, such as localized injection-site infections and fatal systemic infections. The agency has reviewed reports involving four deaths, five wound infections, seven peritonitis cases, 10 cases of septic arthritis, 14 cases of indwelling catheters that required replacement, 16 cases of injection-site infection, and 32 cases of bacteremia, a condition involving bacteria in the blood. In each case, confirmation indicated that contaminated antiseptic products were the cause.

The products all used common antiseptic ingredients, such as alcohol (isopropyl or ethyl), iodophors (povidone iodine, poloxamer iodine), chlorhexidine gluconate (single agent or in combination with alcohol), and quaternary ammonium products (benzalkonium chloride, benzethonium chloride). The organisms involved in the outbreaks include: Bacillus cereus, Burkholderia cepacia, Pseudomonas aeruginosa, Achromobacter xylosoxidans, Ralstonia pickettii, Serratia marcescens, and Mycobacterium abscessus.

These products are advertised as solutions, swabs, pads saturated with a solution, and applicators containing a solution, and are available as single- and multiple-use products.

There are no requirements for topical antiseptics to be manufactured as sterile; therefore, they may become contaminated with bacteria during manufacturing. Labeling that indicates a product is sterile simply indicates that the product was treated with a process during manufacturing to eliminate all potential microorganisms. Topical antiseptics manufactured by way of a sterile process may become contaminated if proper care is not taken when the products are used. The term “non-sterile” on the product label means that the product was not sterilized during manufacturing; it is not an indication that the product contains harmful bacteria.

To reduce risk of infection with improper topical antiseptic use, and to minimize risks of these products becoming contaminated with bacteria, the FDA is asking manufacturers to package in single-use containers antiseptics indicated for pre-operative or pre-injection skin preparation The FDA also suggests:

  • Products should be used according to directions on the label.
  • Antiseptics in single-use containers should only be used one time, on one patient.
  • Healthcare professionals and patients should not dilute antiseptic products after opening them.
  • Applicators and any unused solution should be discarded after the single application.

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