Illnesses in children's hospital prompts discovery of contaminated alcohol pads

"At Children's Hospital Colorado, three patients in the fall of 2010 were seriously ill and had positive cultures of an unusual nature, in this case, cultures associated with Bacillus cereus," said Susan Dolan, RN, MS, CIC, a certified infection control nurse and one of the investigators.

A spore-forming, gram-positive bacteria, Bacillus cereus are historically known to cause food poisoning, but can also cause more serious infections, especially in people with weakened immune systems. The bacteria are capable of surviving in alcohol solutions.

The illnesses prompted an immediate investigation by the hospital's infection prevention and control team and microbiology laboratory. The investigators focused on time, place, persons, procedures, equipment, and products that may have been common to each case. They found three products with which each patient had contact: a solution and device used to disinfect the skin before invasive procedures, a saline solution used to flush intravenous (IV) catheters, and alcohol prep pads that have a variety of uses in healthcare such as disinfecting the cap on an IV catheter.

Within days, lab tests showed B. cereus and other Bacillus species growing from the prep pads, prompting an immediate recall of the product throughout the pediatric healthcare system. The investigators notified the Colorado Department of Public Health and Environment and the Food and Drug Administration of their findings. Both agencies confirmed that the prep pads were contaminated with Bacillus on the outside and inside of the package. The investigation ultimately led to an international recall of the contaminated wipes and the eventual discontinuation of the brand identified in the case.

"Alcohol prep pads are among one of the most widely used products in healthcare, but are not always sterile products," Dolan said. "Many healthcare facilities were using these pads but were not aware they were non-sterile because they were not labeled as such."

As a result of the investigation, Children's Hospital Colorado now uses only prep pads explicitly labeled as sterile. The researchers suggest regulations requiring clear labeling on such products.