A Scope, A Resistant Germ, and Missing Data Walk into a Bar
Just when you thought it was safe to go back into the endoscopy suite...
The battle against the spread of infections related to Olympus duodenoscopes is not over. Although, the outbreak seems to have “officially” begun in late 2015, there were hints of trouble within the scopes as early as 2012. Before we begin with the most recent updates in this debacle, however, it is important to recap the winding road that has been the scope-superbug dilemma, thus far.
Duodenoscopes—flexible medical devices that look like thin tubes and are inserted through the mouth, throat, and stomach into the small intestine—are reusable $40,000 medical devices that contain many working parts, including a camera, and are used for more than half a million procedures a year. The successful dynamics of the device also make it challenging to clean and disinfect. Just over two years ago, cases of drug-resistant infections started popping up in patients who had recently had the procedure that commonly uses duodenoscopes (endoscopic retrograde cholangiopancreatography or ERCP).
Indeed, the Centers for Disease Control and Prevention (CDC) became involved in a cluster of carbapenem-resistant Enterobacteriaceae (CRE) cases related to the University of California, Los Angeles (UCLA) Medical Center in 2015. By January 2016, investigations pushed by Senator Patty Murray, tied 25 outbreaks to duodenoscopes. Nineteen of these outbreaks, including the UCLA one, were traced to scopes made by Olympus.
Despite CDC interim guidance, advanced disinfection practices, and a recall by Olympus last year, there is growing concern that the issues with the scopes were not truly remedied. In fact, Sen. Murray highlighted a recent outbreak in Europe (location not disclosed within the US Food and Drug Administration report) tied to the modified scopes. Although, modifications made by Olympus were done in response to the previous outbreaks and meant to reduce the risk of bacteria getting into the device’s channels and preventing proper cleaning and disinfection, Sen. Murray is now questioning Olympus regarding the devices and the role they played in this most recent outbreak. The senator is specifically asking for data proving that the repaired scopes could be properly disinfected between patient use. Olympus representatives have said the company intends to cooperate with Sen. Murray’s questions; however, this is most likely not the end of the duodenoscope dilemma.
As an infection preventionist, the disinfection of these scopes provides a wholly challenging aspect of infection control and patient safety. The devices are complex and despite their obvious capacity for diagnostic and treatment success, many are questioning if the risk is worth the reward. Sen. Murray has drawn attention to the gaps within follow-up regarding recalled medical devices and modifications that are made to get them back into hospital use. This begs the question: Are we truly following up and ensuring quality control on these modified devices? As Olympus releases their information, it will surely be a time for enhanced surveillance and infection control efforts.
Concerning CRE infections, the CDC is “funding some states who are testing the use of “Detect and Protect” strategies to find germs causing healthcare-associated infections (HAI) and prevent their spread.” These strategies include tracking CRE infections and using the National Healthcare Safety Network, and utilizing the CDC guidelines for these infections and HAI prevention toolkits to initiate prevention activities within healthcare institutions.