Across medical specialties, we can treat patients sooner and less invasively than ever before. In surgical endoscopy, my own field of practice, we’ve replaced scalpel and suture with scopes and energy that allow us to perform complex procedures inside a person’s gastrointestinal tract. Patients are recovering more quickly as a result—and with fewer risks of complications. Being on the cutting edge, it turns out, has nothing to do with actual cutting.
Some risks, however, are harder to eliminate. According to the U.S. Food and Drug Administration, more than one in twenty duodenoscopes—the devices used for procedures like ERCP (endoscopic retrograde cholangiopancreatography), which examine the pancreatic and bile ducts—is contaminated with disease-causing pathogens. Bacterial biofilm can form on the interior surfaces of the endoscope throughout its entire length—not only on the endcap. Cleaning the scope between procedures requires technicians to perform nearly one hundred manual steps—a process that is vulnerable to error in and of itself. Moreover, no reprocessing solution can guarantee a completely clean scope.
If this is the case, why aren’t more doctors voicing their concern about endoscope-associated infections (EAIs)? And why are these infections so underreported? One reason is because EAIs are challenging to track. Without a full-scale outbreak, their signal is hard to spot because the symptoms these infections cause are variable and can show up days or weeks after the procedure. But the risk is real: More than 500,000 ERCPs are performed each year in the U.S. alone. That means that tens of thousands of patients are potentially exposed to pathogenic organisms annually from an unclean endoscope. Many of these patients are immunocompromised and at greater risk of infection—or already infected and may spread their pathogens to others.
We accept many infection-prevention protocols that do not have an immediate empirical benefit to the average clinician. Take hand hygiene, for example. Even though few of us can point to a specific infection caused by skipping hand sanitizer between patients, we understand that hand-hygiene protocols are non-negotiable. (In my hospital, our hand hygiene adherence was even monitored by anonymous colleagues—we called them spies. Compliance was not optional, and we were all on board.) Reducing endoscope-associated infections is going to require the same approach.
The FDA has been diligent in investigating the cause for duodenoscope-related infections and encouraging the development of solutions to mitigate their risk. It now recommends that healthcare facilities begin transitioning to duodenoscopes with disposable caps or, when they’re available, single-use scopes.
Until now, we haven’t had the technology to develop these extremely sensitive instruments in a cost-effective, disposable format. Yet with recent advances in imaging technology and manufacturing science, Boston Scientific has developed the EXALT™ Model D Single Use Duodenoscope—the first and only FDA-cleared single-use, recyclable duodenoscope.
The problem of endoscope-associated infections requires a wholesale shift in our thinking. Let’s not invest and reinvest in partial solutions like more drying cabinets, sterilizers, and disposable endcaps. Single-use duodenoscopes will eradicate the risk of endoscope-associated infection due to inadequate reprocessing. They also have the potential to fundamentally change the field of endoscopy. We hope to apply what we’ve learned in developing EXALT to bring to market additional single-use endoscopes that could be used in other infection-sensitive procedures like bronchoscopy or intraoperative choledochoscopy. Single-use endoscopes also enable rapid iteration because new capital equipment is not needed to upgrade the scope. This may even enable the creation of customized scopes to help optimize the performance of an individual endoscopist.
I can imagine the disbelief of future medical students as they look back and say, “You used to reuse what?” Old timers like me will nod our heads—but mainly with pride, as we remember how it felt to pioneer such meaningful change.