ACTION STEPS Efforts to prevent duodenoscope-related infections have ramped up in recent months.

The deadly outbreak at the UCLA Medical Center in Los Angeles that was linked to difficult-to-clean duodenoscopes certainly got people's attention, but trouble had been colonizing in reprocessing rooms across the country for years.

In the UCLA case, 2 patients who underwent endoscopic retrograde cholangiopancreatography (ERCP) contracted carbapenem-resistant Enterobacteriaceae (CRE) from dirty scopes and died. Outbreaks related to the use of dirty duodenoscopes occurred in 2012 at the University of Pittsburgh Medical Center and in 2013 at Advocate Lutheran General Hospital in Park Ridge, Ill. Earlier this year, Virginia Mason Medical Center in Seattle, Wash., reported that 11 of 32 infected patients subsequently died. New reports suggest duodenoscopes were linked to the infections of 281 patients with a strand of E. coli at Hartford Hospital in Connecticut late last year.

The FDA says it received 75 Medical Device Reports between January 2013 and December 2014, involving approximately 135 patients, but it seems that concrete steps to address problems related to dirty scopes began in earnest this year. In late March, Olympus issued new reprocessing instructions for its TJF-Q180V duodenoscope. That's also when the American Society for Gastrointestinal Endoscopy (ASGE) gathered 60 experts for a duodenoscope infection control summit and the American Gastroenterological Association (AGA) convened a "Getting to Zero" meeting to figure out how to stop device-associated infections. Instruments manufactured by Fujifilm, Olympus and Pentax have been linked to the outbreak; the 3 companies said earlier this year that they will cooperate fully with the FDA to address concerns surrounding duodenoscopes and CRE infection.

Why didn't anyone act sooner? The answer, whether you choose to accept it or not, lies in striking a delicate balance between the undeniable benefit of using the scopes and the true risk of infection.

'A tough spot'
Patients who undergo ERCP are very sick, points out Stuart Gordon, MD, director of gastrointestinal endoscopy at Dartmouth-Hitchcock Medical Center in Lebanon, N.H. Duodenoscopes let physicians access the bile duct with minimal invasiveness during what are often outpatient procedures, says Dr. Gordon, who adds that major surgery is the only other option for treating complicated obstructions in the bile duct that duodenoscopes can remove.

Of the estimated 1 million ERCPs that have been performed over the past 2 years, 150 patients have been infected and less than a dozen have died, says John Allen, MD, MBA, AGAF, president of the AGA and clinical chief of digestive diseases at Yale University in New Haven, Conn.

"Infection risk is quite low," he adds. "It's unbelievably impactful when it happens, but the risks of perforation and bleeding are much, much higher. That's something people have to keep in mind."

Don't assume the UCLA outbreak stimulated real action, warns Bret T. Petersen, MD, a councilor with the ASGE and a professor of medicine at the Mayo Clinic in Rochester, Minn. He says the Morbidity and Mortality Weekly Report (MMWR) published in January 2013 about the outbreak outside of Chicago sparked significant activity at the CDC and the FDA. He also claims the FDA conferred with the device manufacturers in early 2014, if not earlier, to address issues surrounding the outbreaks. The CDC has been conducting conference calls and gathering input from multiple nursing, infectious disease and hospital epidemiology organizations as well as GI specialty groups since February 2014, immediately after the MMWR report was published, according to Dr. Petersen.

"Behind-the-scenes efforts have been ongoing that haven't been announced to the public or media, but it hasn't been a situation of inaction by any of these experts," he says.

"When people die, you could always argue that the response wasn't quick enough," says Dr. Allen, who expects the FDA to release updated cleaning recommendations for all duodenoscopes in the coming months. "I wish we acted sooner, but realistically people reacted pretty quickly."

Dr. Petersen believes the FDA has been put in a tough spot. "The benefit of using these scopes on very sick patients far outweighs the risks, so the FDA realizes it would be inappropriate to pull the instruments from the market," he says. "At the same time, they're trying to push enhancements in scope care while maintaining the benefits."

The FDA's curious call
In 2010, Olympus tweaked the design of its TJF-Q180V duodenoscope, sealing the elevator channel in an effort to reduce risk of contamination. The company did not secure 510(k) clearance for the modification.

Olympus says it determined the modification did not require a new 510(k) application according to the FDA's policy on already cleared devices. The FDA subsequently requested a 510(k) application for the modified scope, according to Olympus, which says it has a pending application for approval and continues to cooperate with the agency.

In a statement, the FDA says it "is not taking action against Olympus regarding its device during our review of the application, because, based on the information currently available, we believe that removal of the device from the market could lead to an insufficient number of available duodenoscopes to meet the clinical demand in the United States of approximately 500,000 procedures per year."

That somewhat stunning admission has one infection control expert wondering about the FDA's true motives in not pulling the Olympus duodenoscope from the market.

"Are the devices staying on the market because the infection rate is so low, or are they staying on the market because there isn't an ample supply to perform these procedures?" asks Lawrence F. Muscarella, PhD, president of LFM Healthcare Solutions in Montgomeryville, Pa. "Those are 2 entirely different rationales.

"Based on an FDA risk assessment, the infection rate is low," adds Dr. Muscarella. "How do they know it's so low if there's no federal law that requires hospitals to report outbreaks?" In fact, the FDA recently confirmed that it did not receive Medical Device Reports for some duodenoscope-associated infections.

REPROCESSING NIGHTMARE
Why Are Duodenoscopes So Tough to Clean?

HARD TO REACH Contaminated elevator channels are believed to have caused outbreaks at facilities across the United States.

Duodenoscopes are arguably the most complex, most challenging reusable instrument to reprocess, says Lawrence F. Muscarella, PhD, an independent infection control expert and president of LFM Healthcare Solutions in Montgomeryville, Pa.

A thin cable woven for durability runs through an elevator channel to a mechanism that lets physicians manipulate tools at the scope's distal tip. In older models, the channel was open, meaning its entire length could be flushed during reprocessing. In recent years, scope manufacturers sealed the elevator channel with the hopes of reducing contamination risks, says Dr. Muscarella.

There's speculation that bacteria is wicking up into the closed channel and being transmitted between patients. Contamination hiding in the crevices around the elevator mechanism attached to the wire cable at the scope's head could also be to blame for infection outbreaks.

When the elevator is manipulated up and down during use, fluids can get above and below it, says Bret T. Petersen, MD, councilor with the American Society for Gastrointestinal Endoscopy and professor of medicine at the Mayo Clinic in Rochester, Minn. Clusters of infection have been linked to scopes with sealed channels and open channels accessible for flushing, so it's not necessarily the newer design that's to blame, he adds.

— Daniel Cook

Moving forward
So what now? How do facility leaders ensure the safety of devices deemed so difficult to clean by so many experts? Is a redesign necessary? "That's a really good question that doesn't have a really good answer," says Dr. Petersen. "It remains to be seen how well the new validated instructions from Olympus perform and what impact the anticipated FDA-revalidated reprocessing instructions will have."

Dr. Petersen believes the new guidance will help curb the outbreaks, but concedes that duodenoscope reprocessing is a multi-step process where the risk of bacterial load is high, partly because of the instrument's complexity and partly because of variations in reprocessing protocols at individual facilities related to staffing levels, time pressures and case volumes.

"In the ideal setting, the validated reprocessing instruction will likely suffice," says Dr. Petersen. "But nuances related to case selection or the human element of reprocessing raise concerns for many of us."

Eventually, says Dr. Allen, duodenoscopes will be redesigned to make manual cleaning easier. Disposable scopes, scopes featuring a removable distal tip that allow for special cleaning of that segment, or a removable cap that covers the elevator channel would be viable options. The FDA promises to fast-track enhanced scope designs, and manufacturers are responding, says Dr. Allen.

In the meantime, Dr. Muscarella suggests you contact the manufacturer of your scopes and have them send a rep to your facility to audit your reprocessing processes and sign off that they're done correctly.

Review your reprocessing training protocols, re-educate staff about issues specific to duodenoscope cleaning and document staff competency assessments now and at regular intervals, advises Dr. Petersen. Meticulously clean the elevator mechanism and surrounding recesses by hand — raise and lower the mechanism to allow for brushing of both sides — even when using an automatic endoscope reprocessor, he suggests. Also document individual scopes used for each procedure to facilitate subsequent testing in the event a patient is found to have a CRE infection.

Most of the public health surveillance focuses on catching CRE bugs that have a specific type of resistance to carbapenem antibiotics, but the outbreak at Virginia Mason involved AmpC—producing E. coli infections resistant to third-generation cephalosporins and carbapenems. "Our investigation uncovered a bug that is potentially more common than the CRE-specific outbreaks people talk about," says Kristen Wendorf, MD, epidemic intelligence service officer at the CDC. "From our perspective, this could be happening anywhere."

To make sure it doesn't, the FDA has issued guidance for "periodic" surveillance culturing of a duodenoscope's elevator channel and distal tip, but leaves the frequency to the discretion of individual facilities that must decide what is both practical and effective for their specific risk profiles. For example, Virginia Mason now cultures and sequesters each scope for 2 days before they're used on patients again.

Added precautions
Work with local infection control experts to assess the prevalence of CRE in your facility and local patient population, says Dr. Petersen. For routine daily practice without known heightened CRE risks, no additional practices beyond diligent standard reprocessing are advised by the FDA at this time, he says. Some facilities, however, employ double cycles of washing and reprocessing, culture sequestration or low-temperature sterilization with ethylene oxide (EtO) after each use.

Reprocessing staffs are caring for duodenoscopes better than they were 12 months ago, says Dr. Petersen. "With what facilities are doing on their own, and what we hope to learn in the next year, practices are changing rapidly," he adds.

Perhaps, but is it fast enough? It's insufficient for facility leaders to say Oh, we've never had a problem, says Dr. Allen, who adds, "Relying on the facts that an infection hasn't happened in your facility and that you reprocess devices correctly are dangerous and incorrect assumptions."