SEATTLE — Following reports of “superbug” infections tied to contaminated medical scopes, the federal Food and Drug Administration has issued additional guidelines for hospitals to prevent the spread of potentially deadly pathogens.
In a detailed MedWatch warning, the agency suggested several specific steps to address the infections detected at Virginia Mason Medical Center in Seattle, Cedars-Sinai Medical Center in Los Angeles and elsewhere. The advice followed a meeting of experts in May.
In addition to “reprocessing,” or cleaning the devices known as duodenoscopes according to manufacturers’ directions, the FDA suggests the following actions:
• Microbiological culturing.
• Ethylene oxide sterilization.
• Use of a liquid chemical sterilant processing system.
• Repeat high-level disinfection.
The new guidelines are aimed at halting infections linked to procedures called ERCP, or endoscopic retrograde cholangiopancreatography, which are performed nearly 700,000 times each year in the U.S. They help diagnose and treat problems with the pancreas and bile duct.
Across the U.S., duodenoscopes from manufacturer Olympus and two other device makers have been linked to 142 multidrug-resistant infections in patients since 2010, the FDA reported.
Virginia Mason officials found that multidrug-resistant bacteria remained on the duodenoscopes even after they had been cleaned according to manufacturer’s directions. The hospital said 39 patients contracted infections associated with the tainted scopes between 2012 and 2014, including 18 who died. It’s unclear what role the infections played in the deaths.
The hospital launched a “culture-and-quarantine” protocol that’s in line with the FDA’s new guidelines. Scopes are cleaned and then cultured for evidence of dangerous bacteria and held until they test free of the pathogens. Implementing the protocol cost the hospital at least $1 million for additional scopes and staff.
The FDA acknowledged that some hospitals may not have the resources to implement the guidelines.
“We recognize that not all health care facilities can implement one or more of these measures, which require specific resources, training and expertise,” the MedWatch statement said.
There are other drawbacks to cleaning methods. Ethylene oxide is toxic and can pose risks to staff who handle it.
Lawrence Muscarella, a patient safety expert who has focused extensively on risks of duodenoscopes, said the new FDA guidelines are “incomplete.” Other scopes, such as bronchoscopes, have been linked to multidrug-resistant infections.
In November 2014, for instance, Olympus reported to the FDA that 14 people had been sickened with dangerous bacteria that remained after cleaning of scopes used to examine airways in the lungs.
“The FDA’s document suggests that only complex endoscopes can transmit superbugs,” Muscarella said. “This is not true.”
Officials with Public Health-Seattle & King County said they’ve received no reports of infections transmitted by other types of scopes.
