The US Food and Drug Administration (FDA), in partnership with the Centers for Disease Control and Prevention as well as several gastroenterology societies and endoscope manufacturers, are looking for ways to reduce duodenoscope-associated transmission of carbapenem-resistant Enterobacteriaceae (CRE), an emerging healthcare threat that may require new standardization and validation of disinfecting techniques and greater use of disposable duodenoscopes. A group of US researchers discussed these techniques in a new paper published in Gastrointestinal Endoscopy.
Duodenoscopes are used for over 500,000 endoscopic retrograde cholangiopancreatographies (ERCPs) annually. In 2013, a widely reported case-cluster of duodenoscope-associated transmission of CRE after ERCP was reported in 38 patients. Since then, similar outbreaks have been reported across the globe. These outbreaks have continued to occur despite rigid adherence to reprocessing guidelines.
While there is no set or definitive standard for duodenoscope reprocessing, the FDA has recently recommended that duodenoscope operators switch to new device designs featuring disposable components that do not need reprocessing. In 2019, FDA clearance was granted to the first fully disposable duodenoscope as a breakthrough device. Since then, several other duodenoscopes with disposable components have also been cleared by the FDA. Although effective, these new designs may incur higher financial costs for centers, which may affect the feasibility of adopting these devices.
In August 2019, the FDA released newly mandated postmarket surveillance study orders for manufacturers in an effort to ensure these new duodenoscope designs reduce rates of contamination. Human factor studies, as well as sampling and culturing studies, were previously mandated by the FDA in 2015 to evaluate duodenoscope reprocessing.
According to researchers, a more robust postmarket system is needed for the safety surveillance of marketed duodenoscopes, primarily due to “the sporadic nature by which the duodenoscope-associated CRE outbreaks” have been previously detected. They suggest that a transparent and mandatory system of postmarketing safety surveillance should be used to monitor and quickly identify adverse events that occur after device approval as well as in the real-world clinical practice setting.
Assessing the response to recommendations may also be a crucial component of assessing postmarketing safety. Gastroenterologists, in conjunction with a multidisciplinary team, should monitor the implementation and adherence to standard cleaning and disinfecting protocols. Digital health data, including data from electronic health records, should also be assessed to better evaluate outcomes of patients who undergo procedures with these devices.
“Medical device safety will be improved by designing a comprehensive regulatory framework that hinges on strong clinical data informing a comprehensive postmarketing surveillance system,” the study authors concluded.
Saleem N, Ismail MK, Tombazzi CR, Soin S, Dhruva SS. Endoscopic transmission of carbapenem-resistant Enterobacteriaceae: implications for Food and Drug Administration approval and postmarket surveillance of endoscopic devices. Published online August 1, 2020. Gastrointest Endosc. doi: 10.1016/j.gie.2020.07.061