When 18-year-old Aaron Young visited UCLA's Ronald Reagan Medical Center he probably thought he was undergoing a standard procedure. But Young became one of seven UCLA patients exposed to CRE (carbapenem-resistant Enterobacteriaceae, a highly antibiotic-resistant bacteria that holds an up to 50% mortality rate, according to the CDC. As of yet two of the exposed patients have died and the LA Times has reported that UCLA believes 179 other patients may have been exposed to the bacteria in a period between October 2014 and January 2015, the same time when Young visited the hospital.
Young and his family have filed a lawsuit alleging negligence and fraud. The alleged culprit is a duodenoscope manufactured by Olympus Corp. Many medical experts believe the design of duodenoscopes (not just those produced by Olympus), which makes cleaning and sterilization of the device difficult, was a direct contributor to the CRE outbreak and has been culpable in similar outbreaks in the past -- dating as far back as 1987, according to CNN. "It certainly is disturbing that a fundamental design issue with these scopes would cause problems for this long," Dr. John Allen, a gastroenterologist and the president of the American Gastroenterological Association, told CNN.
Duodenoscopes are a type of endoscope used to examine body cavities, but are much more complex than their counterparts because they go deeper into the body, through the digestive tract and into the small intestine (the duodenum). The advantage is that they are the least invasive way of draining fluids from pancreatic and biliary ducts blocked by tumors, gallstones, or other conditions. According to the FDA, more than 500,000 duodenoscope procedures are performed in the US every year.
The issue with the device lies in the mechanisms at the tip of duodenoscopes called elevator wire channels. Essentially, these are tiny flaps that hold stents or other components of the scope. However, these tiny channels are prone to collecting Enterobacteriaceae naturally found in the human gut. When this bacteria is brought out of the gut it can mutate -- becoming resistant to antibiotics. Carbapenem class antibiotics (also used to treat infections like E.coli) of which CRE is resistant, are considered drugs of last resort for infections. A bacteria being resistant to this sort of antibiotic is the equivalent of a predator being immune to a hand grenade.
Young's lawsuit alleges that, after redesigning its TJF-Q180V duodenoscope last year, Olympus provided hospitals and doctors with cleaning instructions for an older model rather than sufficient instructions for the new version. The company allegedly failed to update its cleaning protocols despite knowing that the complex design of the duodenoscope made it possible for patients to be exposed to potentially lethal bacteria.
Mark A. Miller, Olympus' executive director of communications and marketing, told CNN the company provides supplemental education materials, including video, on cleaning the devices and the company is working with the FDA to ameliorate future issues.
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The FDA has issued an official warning on the duodenoscopes. In a statement released online, Dr. William Maisel, FDA's Deputy Center Director for Science and Chief Scientist for its Center for Devices and Radiological Health, says the agency was notified of the connection between duodenoscopes and multidrug-resistant bacteria infections back in 2013. He insists that even before this the FDA had been working with companies for years to maximize the safety and efficacy of these devices:
"Since becoming aware of the 2013 infections and additional bacterial infections associated with duodenoscopes, we have further accelerated our work in this area. Specifically, we have gathered and reviewed information from facilities where the infections occurred, identified and studied the devices in question, collected and analyzed information from the manufacturers, analyzed medical device adverse event reports submitted to FDA, and reviewed the relevant published scientific literature ...
"We have been actively working with federal partners, manufacturers, hospitals, medical professional societies, and other stakeholders to better understand the issues that contribute to these infections and what can be done to mitigate them."
Medical establishments have adopted more rigorous cleaning procedures in wake of the UCLA outbreak. Unfortunately there is no easily solution to duodenoscope infections, but as it becomes clear that cleaning standards are proving unreliable,manufacturers are seeking design-based solutions. The current cleaning process to reduce infections for duodenoscopes is a 43-step process that takes about a half hour per scope to complete.
“I believe there should be a way to innovate on the current design,” Christian Escobar, director of marketing at Vision Sciences, makers of the EndoSheath disposal barrier for endoscopes told Design News. “Our platform is based on the simple safety premise that having sterile, disposable instrumentation for every patient is a design model that surpasses a traditional device design that requires significant manual cleaning, disinfection, or sterilization routines and down time between every use to ensure a patient ready device.”
However, due to the complexity of duodenoscopes, no disposable sheaths are currently available for the devices. And curbing this infection issue will require a drastic innovation and much improved design for endoscopes. “Ultimately, manufacturers need to look beyond current incremental design changes to something more innovative, not just developing equipment reliant on additional steps and checks of laborious manual cleaning and sterilization routines,” Escobar said. “While not as publicly noticed, conventional endoscopy safety concerns connected to improper cleaning or failed practices are far too commonplace.”
Chris Wiltz is the Managing Editor of Design News.