The U.S. Food and Drug Administration (FDA) has announced that despite efforts to improve the cleaning and reprocessing of duodenoscopes, decontamination remains a significant challenge, with scope-related infections continuing to harm many patients.
The news comes from FDA's latest report concerning postmarket surveillance studies on rates of contamination after the cleaning and reprocessing of duodenoscopes manufactured by Olympus, Fujifilm and Pentax. In 2015, the FDA ordered these companies to conduct such studies gain a better understanding of the transmission of infections and assess the factors that contribute to their occurrence. The objective was to prevent patient infections associated with the transmission of bacteria from contaminated duodenoscopes, including those from multi-drug resistant bacteria infections.
The implementation of these safety measures contributed to a notable decline in the number of medical device reports associated with patient infections. The number of reports peaked in 2015 at 250 and declined to fewer than 100 reports per year in 2017 and 2018, according to the FDA.
While these results are encouraging, considerable work remains. The FDA noted that it received reports of three deaths of U.S. patients in 2018 related to infections associated with duodenoscopes. In addition, from Oct. 15, 2018, through March 31, 2019, it received 45 reports of patient infection, one report of patient exposure and 159 reports of device contamination.
While the FDA's recommendations for cleaning and reprocessing of duodenoscopes has not changed, FDA indicated it is considering taking additional steps to reduce contamination rates. These include the following:
Consulting with the Centers for Disease Control and Prevention (CDC) and other federal agencies to obtain input and recommendations on infection control and reprocessing of duodenoscopes.
Discussing the matter at the Healthcare Infection Control Practices Advisory Committee (HICPAC) meeting to obtain input on improving the safety of reprocessed devices.
Weighing whether additional recommendations will be necessary to help facilities with proper cleaning and high-level disinfection of duodenoscopes to lower contamination rates.
FDA also indicated that it intends to hold duodenoscope manufacturers accountable if they fail to comply with the requirements of their postmarket surveillance studies. Furthermore, FDA noted that it is working with manufacturers on the development of new duodenoscope designs that could reduce the risk of contamination and disposable duodenoscopes that would eliminate the need for reprocessing.