Push to use disposable duodenoscopes raises feasibility, safety concerns

Much used, expensive and, most importantly, difficult to clean, duodenoscopes are turning into a pain in the neck for everyone involved.

After years of trying to improve the safety of duodenoscopes, an instrument widely used by hospitals and physician practices in the U.S. for minimally invasive procedures in the small intestine, the Food and Drug Administration in late August recommended all facilities transition from reusable devices to ones that are partly or fully disposable.

Given the continued infection risk for patients with the current design of reprocessed duodenoscopes, hospitals and endoscopic practices should invest in the new scopes on the market with a disposable end cap “or to fully disposable duodenoscopes when they become available,” according to an FDA safety communication.

“We recognize that an immediate transition away from conventional duodenoscopes to the newer, innovative models will take time,” an FDA spokeswoman said in an email. “We are encouraging healthcare facilities purchasing new duodenoscopes to invest in the newer, innovative models and develop a transition plan to replace their conventional duodenoscopes with newer models.”

But the new recommendations are presenting challenges for providers, manufacturers and infection prevention specialists. While there is evidence that making a duodenoscope’s end cap disposable reduces germs left on the device, it doesn’t solve all the challenges to efficiently cleaning it, experts say. Further, creating a fully disposable duodenoscope opens up cost concerns along with skepticism around physician adoption. There are also worries about environmental waste considering duodenoscopes are used in more than 500,000 procedures annually in the U.S.

“Where are all of these scopes going? They need to be (disposed of) correctly so we’re not filling landfills with all of these disposable scopes,” said Catherine Bauer, immediate past president of the Society of Gastroenterology Nurses and Associates, which developed guidelines for cleaning the scopes.

The trouble with duodenoscopes began in 2013 when the instruments were linked to patients infected with the superbug known as CRE. Three patients at Ronald Reagan UCLA Medical Center died in 2015 from the infection after they underwent a procedure that uses the scope, endoscopic retrograde cholangiopancreatography.

The FDA soon found contaminants were left on the devices even after the manufacturer’s recommended cleaning protocols were followed. Duodenoscopes, per recommendations from devicemakers, are manually cleaned by technicians before they go through a high-level disinfectant, usually a machine likened to a dishwasher. Most hospitals have in-house technicians who clean these devices daily.

Since the infections became known, the agency has been working with the only three duodenoscope manufacturers—Fujifilm, Pentax Medical and Olympus—on ways to address the problem. The devicemakers have updated their reprocessing instructions with a stronger emphasis on manual cleaning. But postmarket studies mandated by the FDA show technicians are still confused by the directions and often don’t properly complete all the steps.

In response, the FDA recommended manufacturers begin to look into disposable end caps that cover a key component of the scope called the elevator channel, allowing technicians to clean it more thoroughly afterward. Fujifilm and Pentax Medical currently offer duodenoscopes with disposable end caps. Olympus will have one on the market soon.

Although the FDA now recommends hospitals and practices begin to adopt disposable end caps, many infection-control specialists are skeptical about how much of the problem that will solve. The elevator channel is still hard to clean and there are other parts of the device that remain a challenge to sanitize, said Cori Ofstead, an epidemiologist and researcher of endoscope reprocessing. “It’s important to recognize that the (elevator channel) isn’t … the only component that retains soil and the germs that can cause infections,” she said.

Similar to other endoscopes on the market, the duodenoscope has long tubes. It’s challenging for technicians to see inside the tubes so it’s difficult to know if all contaminants have been removed after manual brushing and rinsing.

In fact, a joint survey by Ofstead & Associates and the International Association of Health Care Central Service Materiel Management, also known as IAHCSMM, of 2,334 endoscope technicians found that 30% of respondents reported that one of the biggest challenges to reprocessing these scopes is that they can’t see inside. Nearly 90% of the respondents work in hospitals.

An FDA spokeswoman said the agency recognizes that using a disposable end cap “won’t completely solve the contamination problem” but testing and data show contamination rates are “significantly reduced” with disposable end caps.

In the survey, 26% of technicians said they don’t have enough time to clean the scopes. Regardless of the manufacturer, the instructions for manual cleaning consist of well over 100 steps. Devicemakers argue all those steps are necessary.

“The steps are complex and there are a lot, but we do feel like it leads to a clean device,” said Kurt Heine, group vice president of the endoscopy division at Olympus America.

The Tokyo-based manufacturer has staffers who visit customers to show them how to properly clean the devices but there are likely settings where technicians are pressured to skip steps, said Chris Lavanchy, engineering director of the health services group at the ECRI Institute.

Duodenoscopes on average cost $35,000 each, so providers usually don’t have a large inventory of the devices.

“When things get busy, they (the technicians) will feel the need to move the scope as quickly as possible because they are holding up someone else’s procedure,” Lavanchy said.

Technicians also aren’t always well paid or trained.

Of the respondents in the IAHCSMM survey, 19% had a high school diploma while 36% had technical or vocational training. Another study co-authored by Ofstead found average salary ranged from $17.50 an hour to $32 an hour for technicians who clean bronchoscopes.

“They are the lowest paid and they do the highest risk part of our job—to make sure our scopes are ready for the next patient,” Bauer said.

At New York-based Northwell Health, cameras were installed about three years ago to watch the technicians clean the scopes. The camera is operated by a company that reviews footage to ensure the technicians completed each step.

The scope isn’t released for use until a report comes back affirming that all the steps were taken, said Donna Armellino, vice president of infection prevention at Northwell.

It takes technicians on average 30 minutes to manually clean the scopes and then about 40 minutes for the automated disinfection process. Technicians are given frequent breaks throughout shifts or other duties so they aren’t always doing the same task, Armellino said.

Although using cameras ensures all the steps are done, it doesn’t make sure they were done thoroughly enough that all contaminants have been removed, Ofstead said. “That might make sure people are going through the motions, but it doesn’t tell you if it worked,” she said.

Furthermore, the automated disinfection process after the manual cleaning is futile if the device still has contaminants. “You can’t sterilize poop,” Bauer said.

Ofstead recommends that providers biochemically test scopes after they have been cleaned to see if contaminants remain. She said the process should only take a few minutes. Technicians should also be given good light and magnification tools so they can clearly see inside the tubes.

Doing these extra steps, however, takes time, and research indicates technicians already feel pressured to work quickly, she added. Manufacturers also don’t require validation of cleaning steps. Olympus said such steps aren’t part of its reprocessing instructions but it “support(s) customers who choose to perform this optional step.”

While the manufacturers work on creating fully disposable duodenoscopes per the FDA’s recommendation, Armellino at Northwell said investing in the new scopes will require several considerations including cost and physician support.

Prior to purchasing, new devices are presented to Northwell physicians to get their feedback. Armellino isn’t convinced doctors would like the fully disposable version. “We aren’t really sure if it’s comparable,” Armellino said. “If you look at disposable instruments compared to stainless steel ones, surgeons are going to want to feel that same weight and have that same precision.”

Disposable devices also typically cost more, which would be another consideration, she added.

The duodenoscopes now used in hospitals were likely large investments. “They paid millions of dollars to have that fleet, so they aren’t necessarily willing to make a change until they are convinced it’s absolutely necessary,” Ofstead said.

Patients may even end up eating the added cost in the transition to disposable, said Erin Kyle, perioperative practice specialist at the Association of periOperative Registered Nurses, which has endoscope guidelines. Patients can be billed for disposable medical devices. “At a time where healthcare costs in this country are rising without an end in sight and knowing what we know about the way disposable supplies are billed, that is something we do need to think about,” Kyle said.

Heine at Olympus said as they look into developing a fully disposable duodenoscope, they are considering cost concerns and its performance. “The biggest thing we are looking at is the safety,” he said.

Considering the challenges with both partly disposable and fully disposable duodenoscopes, ECRI’s Lavanchy said it may be time to rethink their overall design. These devices were created with clinical functionality in mind and how to clean them was “almost an afterthought,” he said.