Interim results from the US Food and Drug Administration’s (FDA) mandated postmarket surveillance studies of duodenoscopes indicated a “higher-than-anticipated contamination rates after reprocessing,” FDA said in a safety notice released on Monday.
The postmarket surveillance studies, including human factors studies as well as sampling and culturing studies, were set as requirements in 2015 on all three duodenoscope manufacturers on the US market amid a growing body of patient infection cases. FDA first becoming aware in 2013 of a potential association between multi-drug resistant bacteria and reprocessed duodenoscopes over faulty designs.
The small working parts contained in these flexible, lighted tubes can be difficult to thoroughly clean and disinfect after reprocessing, which can in turn lead to bacterial infection outbreaks. The preliminary results offer new insights into the long-standing issue of hospital-acquired infections in US healthcare as they place more blame on the manufacturers rather than poor sanitation practices among hospital staff.
The new safety communication comes after FDA issued
three separate warning letters to Olympus, FujiFilm and Pentax due to a lack of progress with the required studies—intended to inform the agency’s understanding of the devices in real-world clinical settings—as of March. All three duodenoscope manufacturers in the US completed the initial human factors study testing last month and “at least 10 percent of samples have been collected for the sampling and culturing study,” the agency reported.
The progress on the sampling and culturing studies failed to meet FDA’s expectations as the agency had planned for 50 percent of samples to be processes by the end of August and 100 percent by year’s end.
Interim results on sampling and culturing “indicate higher-than-expected contamination rates after reprocessing, with up to 3 percent of properly collected samples testing positive for enough low concern organisms to indicate a reprocessing failure and up to 3 percent of properly collected samples testing positive for high concern organisms,” FDA said. “High concern organisms are defined as organisms that are more often associated with disease, such as E. coli
, and Pseudomonas aeruginosa
,” it clarified. The World Health Organization classifies
both these examples as leading antimicrobial resistant pathogens.
Preliminary results from the human factors studies “indicate that reprocessing instructions in current user manuals are difficult for reprocessing staff to comprehend and follow,” including the “descriptions of some of the processing steps,” FDA added. The agency is thus working with the three firms “to revise and clarify the user materials to improve comprehension and adherence to reprocessing instructions.”
Following the release of the preliminary results, the agency’s Center for Device and Radiological Health (CDRH) issued a statement for further clarifications. “I want to emphasize that an individual patient’s risk of acquiring infection from an inadequately reprocessed medical device remains relatively low given the large number of such devices in use,” said
CDRH Director Jeff Shuren. FDA saw a 62 percent decrease in the number adverse event reports associated with the use of duodenoscope to “fewer than 100 reports per year in 2017 and 2018” compared to the peak seen in 2015 with 250, Shuren noted.
Shuren also encouraged health care providers to participate in the remaining sampling and culture studies and “consider initiating their own duodenoscope surveillance sampling and culturing to reduce the risk of infections.” Device reprocessing recommendations were outlined in the safety notice as well.
DOJ vs. Olympus
The public outcry that followed reports of patient infections was particularly heavy on Olympus, with lawsuits mounting against the manufacturer that controls most of the US market for duodenoscopes over the past few years. Subsidiary Olympus Medical Systems Corporation and a former senior executive pleaded guilty on Monday in a 2015 case brought on by the US Department of Justice (DOJ) over failures to submit adverse event reports to FDA that linked infections to Olympus’ TJF-Q180V duodenoscopes.
FDA’s Office of Criminal Investigations worked with DOJ and had found the issue stemmed from infections in Europe in 2013 and 2012 associated with Olympus’ duodenoscopes, according to Shuren.
The Olympus subsidiary was fined $80 million and ordered to forfeit $5 million as a result of pleading guilty to three counts of distributing misbranded devices into interstate commerce. Under the plea agreement, the manufacturer is also required to implement new compliance measures.
“Olympus deeply regrets its failure to file and supplement the MDRs [medical device reports] identified in the plea agreement and accepts full responsibility for these failures,” said Hiroyuki Sasa, president and representative director at Olympus.
FDA Provides Interim Results of Duodenoscope Reprocessing Studies Conducted in Real-World Settings: FDA Safety Communication