The January recall of hundreds of millions of alcohol swabs, wipes and pads used in hospitals, clinics and homes, as well as the continuing investigation into the manufacturer of the tainted products by the Food and Drug Administration, was triggered by a troubling discovery made at a Colorado hospital.
As msnbc.com reports, doctors at The Children’s Hospital in Aurora began to look for answers after a few young patients — including a boy battling leukemia — developed bloodstream infections caused by a rare bacteria, Bacillus cereus, normally associated with foodborne diseases.
“It just didn’t make sense,” said Dr. Christine Nyquist, the hospital’s medical director of infection prevention. “Based on the kind of patients they were, the organism, the bacteria, didn’t make sense.”
One of the patients was Peyton Armstrong, a 10-year-old with leukemia, who developed a high fever and intense pain in October within 12 hours of placement of an IV line and a medical port to start chemotherapy treatment. “He was on the brink of death,” his mother said. “The cancer didn’t even matter at that point.”
Experts at the hospital concluded that the bacteria came from contaminated alcohol wipes manufactured by Hartland, Wisc.,-based Triad Group. The company is the only supplier of wipes to the hospital, which uses about 2,500 a day. Hospital officials then informed the FDA, which dispatched inspectors to Triad’s plant on Nov. 29, eventually leading to the company’s voluntary recall.
According to msnbc.com, the FDA’s internal inspection documents show that the agency knew of sterilization problems at Triad as early as 2009. A spokeswoman said the FDA is continuing its investigation, but it has yet to issue warning letters or take any other action against the company.
Two lawsuits have been filed against Triad alleging that patients became infected with Bacillus cereus from the company’s products. In one of the cases, a lawsuit filed last month, the parents of a Houston toddler blamed Triad’s wipes for the child’s Dec. 1 death from acute bacterial meningitis.