Following a number of recalls, contamination with the Bacillus cereus pathogen AND the Elizabethkingia meningoseptic pathogen, and allegations of life-threatening illnesses and death, an investigation into Triad Group’s <"https://www.yourlawyer.com/practice_areas/defective_medical_devices">tainted alcohol prep products, pads, wipes, and swabs has found that most—two-thirds—of the tested samples were contaminated with what MSNBC described as “dangerous bacteria.†The samples included contaminated products from eight out of 10 different lots, according to a government report, added MSNBC.
The U.S. Centers for Disease Control and Prevention (CDC) provided additional details yesterday on the medical wipes produced by H&P Industries Inc., which also does business as the Triad Group of Hartland, Wisconsin, explained MSNBC. In a summary, the agency reported that at The Children’s Hospital in Aurora, Colorado, 60 samples from 10 different lots of the prep pads were tested; 40 tested positive for contamination with Bacillus cereus. Wipes and other single use items such as syringes were tested by the facility after two children became seriously ill, said MSNBC. Both children developed acute, life-threatening infections as a result of contamination with the Bacillus cereus bacteria.
The findings led to a U.S. Food and Drug Administration (FDA) investigation that led to the recall of the alcohol prep products, pads, wipes, and swabs. Also, as we wrote last week, H&P recalled all lots of povidine iodine prep pads over concerns of contamination with another potentially fatal bacteria, Elizabethkingia meningoseptic.
More intense testing in Colorado unearthed an astounding 21 separate isolates of Bacillus cereus in the pads and eight from patients with positive cultures from May through November 2010, said MSNBC. While the strains differ, because so many isolates were found and because of the time between looking at patient samples and testing wipes, the team concluded that the wipes could be the culprit in the children’s illnesses, explained MSNBC.
At last count, the FDA received 161 reports of adverse events related to Triad Group’s tainted alcohol prep products, pads, wipes, and swabs, and has said it is “very concerned,†but has not moved into action. ABC News noted that the FDA’s Triad wipe recall was a Class 2, not the more serious Class 1.
Despite the concern, stronger measures have not been taken and many feel that Triad, H&P, and the FDA have not moved swiftly and thoroughly to eradicate these contamination issues. For instance, the agency could issue warnings, sanctions, or injunctions or could seize products but is, instead, continuing to analyze products while deciding on its next steps. FDA officials said there was no “imminent health hazard,†quoted MSNBC concerning contaminated Triad wipes, despite that some children at The Children’s Hospital in Denver developed bloodstream infections that were determined to be from Bacillus cereus, later cultured from the contaminated wipes, said MSNBC.
Meanwhile, two lawsuits have been filed against Triad over one toddler who died from meningitis and a man who suffered significant injury mandating cardiac surgery. Both contracted infections linked to Bacillus cereus infection, which can also cause meningitis, and both were treated with the recalled pads. A third lawsuit is expected to be filed by the parents of a 10-year-old leukemia patient, Peyton Armstrong, who fell seriously ill, allegedly as a result of the contaminated products, said MSNBC.
Shelly Burgess, a spokeswoman for the FDA, said that the investigation continues; however, MSNBC learned that inspection documents confirmed that the FDA was aware of sterilization and contamination issues at Triad since at least 2009.
