Experts from Virginia Mason Medical Center and elsewhere share tips on how to safely reprocess duodenoscopes to avoid infections
Duodenoscopes — a specific type of endoscope used in endoscopic retrograde cholangiopancreatography procedures — have been tied to numerous infections and even patient deaths at hospitals across the nation, prompting the Food and Drug Administration to issue a safety warning and leading some hospitals to reconsider how to clean the scopes.
"It is almost impossible to clean correctly," says Mark Duro, the director of sterile processing operations at New England Baptist Hospital in Boston, about the scopes. Or, as the FDA put it in its safety communication, "the complex design of ERCP endoscopes may impede effective reprocessing."
This complicated design likely led to infections caused by antibiotic-resistant bacteria at Virginia Mason Medical Center in Seattle and at Ronald Reagan UCLA Medical Center in Los Angeles in recent months, and has been problematic in years past.
Andrew Ross, MD, the section chief for gastroenterology at Virginia Mason, has been dealing with these infections first-hand since an outbreak was discovered at his hospital from 2012 through 2014. Since the outbreak, the hospital has made changes in its reprocessing procedure for ERCP endoscopes which, he told the Seattle Times, "makes us the safest place in the country to have this done."
In an interview with Becker's, he says "We're working hard to share this process [and] what we're doing with other hospitals."
In the new protocol, Virginia Mason staff still reprocesses the scope according to manufacturer's guidelines. After that, the scope is cultured and then put in quarantine for 48 hours, and then the cultures are checked for pathogenic bacteria. If the culture is negative after 48 hours, the scope is reintroduced into the pool for use on patients, Dr. Ross explains.
However, if the test comes back positive for bacteria, they are re-cleaned, re-cultured and re-quarantined until the cultures come back negative.
To make the updated process viable for the hospital, Virginia Mason also added 20 new scopes, bringing its total number of scopes to 28, and added more staff members to execute the cleaning. This cost the hospital roughly $1 million, according to Dr. Ross.
"To us, this was, without question, worth it, because we did this on behalf of safety of our patients," he says.
While this new approach has worked at Virginia Mason, Dr. Ross stresses, "It is difficult for me to comment on what other people should be doing. But as an industry standard, we should do the best that we can to ensure we don't place scopes in patients that could harm them."
Below are two other recommendations from Mr. Duro and Wava Truscott, PhD, director of medical sciences and clinical education with Halyard Health, on how to make reprocessing ERCP scopes as safe as possible given the current scope design:
Hire certified staff. Two organizations currently offer certifications in sterile processing: the International Association of Healthcare Central Service Materials Management and the Certification Board for Sterile Processing and Distribution. According to Mr. Duro, only two states, New Jersey and New York, currently require staff to be certified in sterile processing. Certification requirement is also moving forward in other states, including Massachusetts.
Since the ERCP endoscopes are very complex and difficult to clean, having certified staff handling the process just makes sense, says Mr. Duro. "Have trained, educated and certified staff that are aware of what they're doing," he urges. "They have a major impact on the outcome of the patient."
Dr. Truscott agrees, noting that hospitals should have a system in place enabling people to become certified. "It's a great way for individuals to feel more professional," she says. "They take on a new mantel of responsibility and confidence and learn so many important things."
Use the right tools. Because the ERCP scopes are so difficult to clean using the right tools are of upmost importance. "You really need to use the brushes that are recommended," Dr. Truscott explains, even though some hospitals "try to cut expenses by getting cheap brushes," she says. "If you buy cheap brushes they tend to come apart" which can lead to infections, she adds.
Mr. Duro puts it more simply, saying the right people have to "have the right tools to get the job done." In addition to having up-to-date reprocessing equipment, this includes giving staff adequate access to the device's instructions for use and cleaning.
While these tips can help make reprocessing the ERCP scope as safe as possible for patients, Mr. Duro and Dr. Truscott both agree that change is necessary from the FDA or manufacturers.
"Device design has much to do with the cleanability of the instrument," says Mr. Duro. "You can do the best job cleaning it, however if the device is designed to harbor microorganisms, the best cleaning may not be effective even if following the instructions for use perfectly."
Additionally, he adds that scope manufacturers need to provide effective, specific and safe instructions for use and disinfection to help guide the staff, as well as training from the manufacturer accompanied with staff competencies.
Dr. Truscott adds, "The FDA needs to be working with all manufacturers of endoscopes to figure this out, to make it stop happening. We have to figure out ways to clean these things."
But since those changes are not yet guaranteed, or even in motion, for now the safest course of action seems to be getting the right trained people following instructions to the T with the right tools.