FDA Issues Reminder About Triad Alcohol Swab Recall

Allison Gandey

February 04, 2011

February 4, 2011 — The US Food and Drug Administration (FDA) is reminding people again about the possible contamination of Triad nonsterile alcohol prep pads. The product was voluntarily removed from the market last month over concerns surrounding Bacillus cereus, a bacterium that can be harmful to humans.

"Healthcare professionals should always check the labeling on a prep pad to determine if it is sterile or nonsterile," Karen Weiss, MD, director of the Safe Use Initiative in the FDA's Center for Drug Evaluation and Research, said in a news release dated February 1. "Nonsterile pads are not intended to prep patients prior to procedures requiring strict sterility measures and should not be used on patients with a depressed immune system, to prep patients for catheter insertion, or to prep patients prior to surgery."

Manufacturers often package a prep pad with an injectable drug, selling them as a kit, but not all marketed pads are sterile. The FDA recommends that healthcare professionals and consumers check the label to confirm that the product is sterile.

"They may also want to consider washing the area with soap and water prior to using the antiseptic for skin surface preparation," the agency noted in a news release.

Risk for Neurology Patients

Daniel Kantor, MD, president of the Florida Society of Neurology and medical director of Neurologique, cautioned that neurologists and their patients might want to think twice before following these instructions.

Check the label. Sterile prep pads remain available.

"These alcohol pads are widely used for preparation for minor procedures and at home by hundreds of thousand of patients with multiple sclerosis, migraine, and other diagnoses," Dr. Kantor told Medscape Medical News."Simply washing the area to be injected with soap and water and then rubbing that same area with a potentially contaminated alcohol pad is probably just as dangerous as using the alcohol pads alone. In fact, it could be argued that by prewashing with soap and water, you wash the other bacteria competing with Bacillus cereus and thus make it easier for that dangerous bacterium to survive unfettered by competition."

Dr. Kantor says he worries about the neurology patients using alcohol swabs supplied by manufacturers and specialty pharmacies for their injectable medications who are unwittingly exposing themselves to dangerous bacteria. "This is especially concerning for patients with alterations in their immune system."

Dr. Kantor has been using social media such as Twitter, LinkedIn, and Facebook to remind physicians and patients of the risks.

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