They say cleanliness is next to godliness. But as the outbreaks of carbapenem-resistant enterobacteriaceae linked to duodenoscopes illustrate, cleanliness in health care isn’t about the high moral ground. It’s about preventing harm, even death.
Duodenoscopes are flexible endoscopes that can reach the pancreatic and biliary ducts, and they’re used to perform about 500,000 procedures each year. Of course they are cleaned between procedures. But as an FDA guidance makes clear, that cleaning is a multiple step process that involves—“the physical removal of soil and contaminants”—and sterilization.
ECRI’s Chris Lavanchy discusses cleaning flexible endoscopes.
“What people don’t focus on is the cleaning,” says Chris Lavanchy, an engineering director at the ECRI Institute, a health research organization in suburban Philadelphia. ECRI has ranked inadequate cleaning of flexible endoscopes Number 1 on its list of the top 10 health technology hazards for 2016.
Most flexible endoscopes are sterilized with liquid chemicals, Lavanchy explains. But he says sterilization without cleaning is a “fool’s errand” because residual organic matter can shield pathogens from the killing power of sterilizing agents. Cleaning endoscopes is a manual task done with brushes and fluids. The pace may be hectic. “It is easy to see how shortcuts could occur,” observes Lavanchy.
The FDA has ordered the three manufacturers who market duodenoscopes in the United States to conduct studies of how their products are cleaned and sterilized. Perhaps something new will be discovered. Regardless, contaminated duodenoscopes are a reminder that keeping high-tech health care safe and effective often depends on low-tech tasks like cleaning instruments.