In January, the National Hemophilia Foundation released Medical Advisory #412 advising people to discontinue using over-the-counter, nonsterile alcohol swabs, alcohol prep pads and alcohol swabsticks manufactured by the Triad Group, Inc. Users were also advised to return them to the product distributor. The advisory was based on action taken by Triad, in cooperation with the U.S. Food and Drug Administration, to voluntarily recall certain lots of these products in light of possible contamination with Bacillus cereus, a bacterium that can cause serious infection if it gets into the bloodstream. While Triad was the sole manufacturer, multiple companies packaged, marketed and distributed the products in question.
A report published in the Centers for Disease Control and Prevention's Morbidity and Mortality Weekly Report (MMWR) in March revealed that two cases, both occurring at The Children's Hospital (TCH) in Aurora, CO, during Fall 2010, were the primary impetus for the recall. The TCH investigation found that two patients-a child with newly diagnosed leukemia and an infant with congenital heart disease--developed clinical sepsis (severe infection in the bloodstream) from exposure to Bacillus cereus. Using blood and tissue cultures, investigators discovered that nonsterile Triad alcohol prep pads (APPs) used on both patients during the implantation of intravenous lines contained the bacterium. The infections necessitated extensive follow-up care, including treatment with antibiotics and surgical procedures to remove tissue and venous access lines. On November 19, 2010, TCH stopped using nonsterile APPs, opting to use sterile APPs from another manufacturer.
Investigators also reported shortcomings in the labeling of the products. They found that neither the boxes containing APPs nor the individual packaging indicated whether pads were sterile or nonsterile. They added that sterile products should not be mistaken and/or interchanged for nonsterile products.
The findings prompted recommendations to both manufacturers and healthcare providers. "Health-care facilities, health-care providers, and users of APPs should know whether the APPs in clinical use are sterile or nonsterile and be aware of the risk for iatrogenic infection if nonsterile APPs are used. Manufacturers should know the importance of clearly labeling their products as sterile or nonsterile to avoid misuse by health-care facilities and health-care providers," concluded the investigators.
Read the MMWR report.