Triad Alcohol Prep Pad Problems Confirmed in Two-Thirds of Tested Wipes

A Colorado hospital reports that two-thirds of recalled Triad alcohol prep pads that it tested were contaminated with dangerous bacteria. 

The Children’s Hospital, in Aurora, Colorado, was the first healthcare facility to report bacterial contamination of Triad Group alcohol prep pads, swabs and swab sticks, which led to a massive recall earlier this year for tens of millions of supposedly sterile Triad wound and injection site prep products.

The hospital says that it tested 60 sterile alcohol wipes from different Triad Group lots, and found that at least 40 of them had contamination.

The Children’s Hospital became concerned after two children being treated at the facility contracted hospital-acquired infections. The hospital’s laboratory determined that both children had a Bacillus cereus infection.

After the facility determined that there had been no violations of sterile surgical standards, the hospital turned its attention to the Triad wipes and found widespread contamination, according to a field report published March 25 by the U.S. Centers for Disease Control and Prevention (CDC).

The hospital found contamination in eight out of 10 different manufacturing lots of the products, the CDC reports. The findings add weight to prior reports by FDA inspectors who indicated that Triad Group has systemic problems producing sterile, safe medical products.

Triad Group issued an alcohol prep pad recall in early January 2011, after it was discovered that tens of millions of prep pads, swabs and swabsticks tainted with the bacteria Bacillus cereus may have been distributed to consumers.

The alcohol prep pads and wipes were commonly used in hospitals and packaged with a number of medications. They were sold under the Triad brand name, as well as under a variety of other labels, including CVS, Walgreens and Cardinal Health.

FDA inspectors have known of problems at the company’s manufacturing plant in Hartland, Wisconsin, since at least July 2009, when they began raising concerns about the company’s sterilization technique. But problems at the plant continued.

In recent FDA inspection reports, Triad Group employees packed acne pads into containers with bare hands, water pipes used in making mouth wash and glycerin suppositories were infested with microbial contamination, and workers were caught failing to add the active ingredient to children’s cold medicine and then claiming they had added it.

At least two Triad alcohol prep pad lawsuits have been filed in recent months; one by the parents of a two-year-old Houston boy who died due to a Bacillus cereus infection, and another by a Tennessee man who alleges that a Triad alcohol prep pad infection left him permanently disabled.

Bacillus cereus is responsible for about two percent of all foodborne illness, according to the CDC. Illness comes within 24 hours after exposure and can result in a diarrheal illness. Serious illness and permanent injury are very rare.