Two-thirds of tested samples of alcohol prep pads tied to a massive recall, serious infections and death were contaminated with dangerous bacteria, including tainted products from eight of 10 separate lots, according to a new government report.
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The Centers for Disease Control and Prevention on Thursday offered more detail about problems with medical wipes manufactured by H&P Industries Inc., which does business as the Triad Group of Hartland, Wis.
In a brief field notes summary, the CDC reported that The Children’s Hospital in Aurora, Colo., tested 60 samples of Triad Group alcohol prep pads last fall and determined that 40 were contaminated with the bacteria Bacillus cereus. The bacteria were detected in wipes from eight of 10 different manufacturing lots, the report said.
Hospital officials tested the wipes — as well as other single-use, disposable items including syringes and sterile applicators — after two children, including a 10-year-old boy with leukemia and an infant with congenital heart disease, developed sudden, life-threatening infections. Both were caused by Bacillus cereus, laboratory cultures determined.
The Colorado findings sparked a federal Food and Drug Administration investigation that prompted the voluntary recall of the alcohol wipes, officials said.
Hundreds of millions of Triad Group alcohol wipes used in hospitals and clinics and sold under the private labels of grocery stores such as Safeway and Kroger and drugstores such as Walgreens were covered by the January recall because of potential contamination with the bacteria. The products are often used to clean skin before injections; many may still be in people’s homes. For a list of recalled brands, click here.
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In addition, H&P Industries Inc. last week recalled all lots of its povidine iodine prep pads because of contamination with different potentially deadly bacteria, Elizabethkingia meningoseptica, which have been tied to meningitis infections in newborns and to flesh-eating bacteria disease. Those pads are used to clean minor burns and scrapes and before surgery.
Can't rule out pads as cause of infections
Detailed laboratory tests in Colorado detected 21 different isolates of Bacillus cereus in the pads and eight isolates from patients with positives cultures from May through November 2010. The exact strains did not match, the report said. However, because so many different isolates were detected, and because of a time lapse between assessing patient samples and testing the wipes, investigators determined that the wipes could have caused the children’s infections.
H&P Industries faces at least two lawsuits in connection with the alcohol wipes. The parents of a 2-year-old Houston boy sued after the child died of meningitis caused by Bacillus cereus and a 55-year-old Tennessee man said he developed a life-threatening heart infection that required surgery. Both parties blame tainted wipes. In addition, the parents of the 10-year-old Colorado leukemia patient, Peyton Armstrong, have said they plan to sue.
The firm closed down the division that makes alcohol wipes and lubricating jelly, also recalled, because of the FDA investigation and news reports by msnbc.com, H&P's chief operating officer, Eric Haertle, said in a letter last month to customers, vendors and employees. Haertle has not responded to repeated msnbc.com requests for comment.
Bacillus cereus bacteria are resistant to killing by alcohol and have caused rare cases of disease in health care sites, the CDC report noted. The bacteria are commonly found in soil and usually associated with foodborne illness.
Elizabethkingia meningoseptica bacteria are usually associated with fish and frogs and rarely with human infections. However, they have been implicated in infections in infants, in patients on ventilators and in orthopedic patients who received tissue from deceased donors.
The FDA investigation into H&P Industries is continuing, said spokeswoman Shelly Burgess. Though inspection documents confirm the agency knew of problems with sterilization and contamination at the Triad Group plant as far back as 2009, no sanctions have been levied against the Wisconsin firm. An FDA official last week said the agency needs more time and analysis to decide what action to take.
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