An outbreak of drug-resistant E. coli in a Washington state hospital has been linked to contaminated endoscopes, according to a study published in Infection Control & Hospital Epidemiology.
The study reports that the specialized endoscopes may infect more patients even when the hospital precisely follows the manufacturer’s recommended cleaning procedures. Thirty-two patients at Seattle’s Virginia Mason Medical Center were infected with antibiotic-resistant E. coli between November 2012 and August 2013. Eleven patients who contracted the infection died, but hospital officials said not all the deaths could be linked to the E. coli infection because the patients all suffered from cancer or other serious illnesses. The hospital had followed the company’s procedure for cleaning the scopes, according to FierceHealthcare.
The manufacturer’s cleaning instructions may not be sufficient to fully sterilize the devices. A similar situation arose with outbreaks of carbapenem-resistant Enterobacteriaceae (CRE) in two California hospitals. More than 3 in 10 infected patients died over the course of the investigation; seven deaths occurred during hospitalizations within 30 days of the hospital identifying the superbug as E. coli, FierceHealthcare reports. Dr. Kristen Wendorf of King County public health department said, “In the wake of the recent outbreak of CRE due to contaminated endoscopes, we suspect endoscope-associated transmission of bacteria is more common than recognized and not adequately prevented by current reprocessing guidelines.”
Virginia Mason Medical Center examined Olympus scopes used there and found seven of eight had mechanical defects that may have contributed to the bacteria’s spread. The hospital is now manually cleaning the scopes, and is using procedures beyond what the manufacturer recommends. After cleaning, the hospital now quarantines each device for 48 hours, the Los Angeles Times reports. Still, the hospital found 3 percent of scopes were still contaminated, and staff repeated the cleaning process. Virginia Mason spokesman Gale Robinette assured the Times, “No scope is used at Virginia Mason until the cultures are negative.”
The FDA explains that duodenoscopes are used to take tissue samples for biopsy or to treat certain abnormalities. The flexible, lighted tube with a miniature camera is threaded through the patient’s mouth, throat, and stomach, then into the duodenum. About 500,000 duodenoscope procedures are performed annually in the United States and regulators stressed that the device is essential for treating tumors, gallstones and other blockages around the pancreas and bile ducts. In the U.S., Olympus, Pentax Medical and Fujifilm make the devices.
In February, following CRE outbreaks at two Los Angeles hospitals, the Food and Drug Administration (FDA) issued a warning about duodenoscopes New FDA guidelines recommend that hospitals take scopes out of service until they were verified to be pathogen-free, FierceHealthcare reported. In March, the FDA revised guidelines for manufacturers of the scopes, requiring proof that they can be adequately cleaned before the scopes enter the market.
Health officials call it “especially disturbing” that although the Seattle hospital had meticulously followed the company’s instructions for cleaning the scopes, there were still 32 infected patients.