Hospitals are discovering it’s nearly impossible to clean endoscopes blamed for spreading deadly bacteria that have sparked lawsuits from patients and sent device regulators scrambling for a fix.
The Seattle hospital where a fatal, drug-resistant superbug was spread by contaminated scopes is still finding germs on the instruments even after heightening its cleaning procedures, researchers have reported in a journal article.
Virginia Mason Medical Center redoubled efforts to clean the scopes with “meticulous manual cleaning” last year after it learned of an outbreak that affected 32 patients, including 11 who died. The hospital began taking the devices, known as ERCP endoscopes or duodenoscopes, out of service for 48 hours between procedures and culturing them to check for bacteria. Even with more diligent cleaning, the hospital found that 3 percent of the scopes tested positive for contamination and had to be cleaned again.
Virginia Mason uses the scopes in about 1,800 procedures a year, according to spokeswoman Gale Robinette. That means that, on average, about one scope a week is still contaminated after cleaning.
If every U.S. hospital had a similar rate, that would mean 15,000 operations a year performed with dirty ERCP endoscopes.
We don’t know how the 3 percent rate at Virginia Mason compares with rates elsewhere, because few others test their scopes after each operation. That approach is part of the “costly and extraordinary measures” Virginia Mason took to reduce the risk of transmission, according to the paper, published online in the journal Infection Control and Hospital Epidemiology.
One model of endoscope associated with the outbreaks, manufactured by Olympus, was on the market for years without being cleared through the Food and Drug Administration’s device oversight process. The agency said Olympus had issued new cleaning instructions, and the company is expected to ship hospitals a new brush to reach intricate parts of the scope.
The FDA, which regulates medical device makers, suggests taking devices suspected to be linked to patient infections out of service for further cleaning and testing. But neither the agency nor Olympus has instructed hospitals to follow Virginia Mason’s lead and hold all ERCP scopes for testing before they are used in the next procedure.
