Federal Regulators Seek Update on OTC Topical Antiseptics Following Death, Injury Reports

FDA-proposes-topical-antiseptic-reformInfection concerns, some serious, have prompted the U.S. Food and Drug Administration (FDA) to request label and packaging changes for some over-the-counter (OTC) topical antiseptic products.

The request comes after an ongoing FDA evaluation of what the agency indicated was “infrequent but continuing” infection reports that have been blamed on antiseptic products labeled for pre-operative or pre-injection skin preparation.

When appropriately used, the topical antiseptic products are considered to be a safe and effective way in which to reduce bacteria on patients’ skin prior to their undergoing surgery or receiving injections. Contamination takes place when users introduce organisms into the OTC topical antiseptic product. To reduce this risk, says the FDA, health care professionals and patients should follow product label directions carefully.

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

Reactions have spanned a range of outcomes that include localized infection site infections and fatal systemic infections. The FDA reviewed reports that involved four deaths, five cases of wound infections, seven cases of peritonitis, 10 cases of septic arthritis, 14 cases of indwelling catheters requiring replacement, 16 cases of injection site infection, and 32 bacteremia cases. In each case, infection report confirmation indicated that the infections were caused by contaminated antiseptic products.

The products all contained common antiseptic ingredients, including 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). Organisms involved in the infection outbreaks include: Bacillus cereus, Burkholderia cepacia, Pseudomonas aeruginosa, Achromobacter xylosoxidans, Ralstonia pickettii, Serratia marcescens, and Mycobacterium abscessus.

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

No requirements are in place for topical antiseptics to be manufactured as sterile. Because of this, the products might become contaminated with bacteria in the manufacturing process. What’s more, labeling that indicates a product is sterile simply means that the product was treated with a process during manufacturing to eliminate all potential microorganisms. Topical antiseptics manufactured with a sterile process may become tainted should proper care not be taken when those products are used. The term “non-sterile” on the product label means that the product was not sterilized in manufacturing; the term does not mean that the product contains harmful bacteria.

To reduce infection use when topical antiseptic is used, and to minimize risks of these products becoming contaminated with bacteria during use, the FDA asks those manufacturers that package antiseptics indicated for pre-operative or pre-injection skin preparation to ensure the products are packaged in single-use containers. The FDA also suggests:

  • Products should be used according to the directions on the label.
  • Antiseptics in single-use containers should only be used one time and on one patient.
  • Health care professionals and patients should never dilute antiseptic products after opening them.
  • Applicators and unused solution should be discarded after the single application.
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