November 27, 2013
Packaging Changes Sought for Preinjection
Skin Prep Products

Washington, D.C.—The FDA is warning that the products pharmacists use for preinjection skin preparation, as well as other OTC topical antiseptic products, can cause infection outbreaks when used improperly.

The FDA recently called for label and packaging changes to enhance the safe use of certain OTC topical antiseptic products, with the action prompted by “infrequent but continuing reports of infections resulting from antiseptic products labeled for preoperative or pre-injection skin preparation.”

“When used properly, topical antiseptics are safe and effective products to reduce the number of bacteria on patients’ skin prior to surgery or injections,” according to a safety alert. “However, most often, contamination of topical antiseptics occurs when organisms are introduced into the product by users. Therefore, health care professionals and patients should follow all label directions to decrease the chances of infection.”

The FDA said outcomes ranged from localized infections at injection sites to systemic infections that resulted in death, including reports of four deaths, five cases of wound infection, seven cases of peritonitis, 10 cases of septic arthritis, 14 cases of indwelling catheters requiring replacement, 16 cases of injection-site infection, and 32 cases of bacteremia.

All commonly used antiseptic ingredients were involved—alcohol, iodophors, chlorhexidine gluconate, and quaternary ammonium products—with organisms implicated in the outbreaks including Bacillus cereus, Burkholderia cepacia, Pseudomonas aeruginosa, Achromobacter xylosoxidans, Ralstonia pickettii, Serratia marcescens, and Mycobacterium abscessus.

The FDA pointed out that the products, marketed as solutions, swabs, pads saturated with a solution, and applicators containing a solution, are currently available as both single-use and multiple-use products. In addition, the safety alert noted, topical antiseptics are not required to be manufactured as sterile and so may become contaminated with bacteria during manufacturing.

“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 pre-injection skin preparation in single-use containers,” according to the FDA alert.

Public health officials also cautioned healthcare providers to ensure that products are used according to the directions on the label and that antiseptics in single-use containers be applied only one time to one patient. Diluting antiseptic products after opening them is not recommended, and applicators and any unused solution should be discarded after the single application.

In an accompanying document, the FDA said it still considers OTC topical antiseptics for preinjection or preoperative skin preparation safe and effective to reduce bacteria on the skin prior to surgery or injections and is not suggesting that pharmacists and other healthcare professionals stop using them.

U.S. Pharmacist Social Connect