On Jan. 5, 2011 The Triad Group of Hartland, Wis., recalled all lots of its alcohol prep pads and swabs citing concerns about the product’s potential contamination with Bacillus cereus, a bacterium that can be harmful to humans.
“Health care professionals should always check the labeling on a prep pad to determine if it is sterile or non-sterile,” said Karen Weiss, M.D., director of the Safe Use Initiative in the FDA’s Center for Drug Evaluation and Research. “Non-sterile 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.”
Weiss said many patients in hospitals are particularly susceptible to infections, and the FDA recommends sterile antiseptics (including chlorhexidine gluconate, alcohol or iodine applicators, pads, and swabs) in that setting.
Manufacturers often package a prep pad with an injectable drug, selling them as a kit. But not all marketed pads are sterile. Some are marketed as non-sterile alcohol pads. If a pad does not state “sterile” on the label, health care professionals should be aware that they are using a non-sterile pad.
Health care professionals and consumers should check the label to confirm that the product is sterile, and may also want to consider washing the area with soap and water prior to using the antiseptic for skin surface preparation.
For more information:
- Triad Group Press Release on Recall of Alcohol Prep Pads1
- CDC – Guideline for Prevention of Surgical Site Infection
Media Inquiries: Christopher Kelly, 301-796-4676, [email protected]
Consumer Inquiries: 888-INFO-FDA