FDA Probe Into Patient Infections Over Contaminated Duodenoscopes Hits Turning Point

Regulatory NewsRegulatory News | 30 August 2019 |  By 

Manufacturers of duodenoscopes in the US have come under new pressure to address the increased risk of patient infection, per the US Food and Drug Administration’s (FDA) request.
A Thursday safety communication notes how a probe dating back to FDA becoming aware of a potential association between multi-drug resistant bacteria and the use of duodenoscopes in 2013 is now getting to the heart of the matter, stemming from difficulties for hospital staff to follow reprocessing instructions due to faulty device designs. Components of the devices, which are used in upward of 500,000 US endoscopic retrograde cholangiopancreatography procedures each year, can pose patient infection risks if not properly cleaned and disinfected.
FDA is now recommending a transition away from fixed endcap duodenoscopes toward newer model designs that reduce or eliminate the need for reprocessing. The move refines the probe to address the agency’s concerns of high contamination rates previously associated with such scopes as well as the reprocessing challenges as it urges a shift to newer designs that include disposable components such as disposable endcaps or to fully disposable duodenoscopes.
Following a 2016 report from a US Senate committee cited ineffective FDA oversight as the culprit of the superbug outbreaks linked to duodenoscopes that spread across the US and the EU, Olympus, Fujifilm Medical Systems and Pentax Medical each drew an FDA warning letter last March after having failed to comply with the approved study plans to conduct the postmarket surveillance studies (PASs) set as requirements on all three manufacturers in 2015.
Both the interim results of the PASs reported last December and the results of the most recent studies from each manufacturer show higher than expected contamination rates and the presence of high-concern organisms, at least partly due to the growing threat of antibiotic resistance. Sen. Patty Murray (D-WA) sent a letter to each of the three duodenoscope makers in May, raising concerns with the lack of clarity on steps to satisfy the concerns with patient safety.
FDA now cites duodenoscopes incorporating disposable components to “facilitate cleaning, reduce contamination and reduce disease transmission following reprocessing” in arguing that, “the best solution to reducing the risk of disease transmission by duodenoscopes is through innovative device designs that make reprocessing easier, more effective, or unnecessary.” The argument further the potential for disposable designs to “reduce between-patient duodenoscope contamination by half as compared to reusable, or fixed endcaps,” according to the agency.
The safety communication notes that Fujifilm and Pentax Medical have already received FDA clearance for two duodenoscopes with disposable endcaps that facilitate reprocessing. An Oympus spokesperson told Focus that the company is collaborating with FDA, supportive of FDA’s “recommendation of a gradual transition to duodenoscopes with disposable components and is thus “working closely with FDA to bring the product to market as early as possible.”
Other actions FDA is taking in collaboraiton with manufacturers include increasing the supply of disposable cap duodenoscopes, adding real-world contamination rates in the labeling of existing fixed endcap duodenoscopes, conducting new postmarket surveillance studies to verify that new designs reduce the contamination rate and seeking additional advice during an upcoming advisory committee meeting, among others. FDA offers outlines a set of recommendations to aid hospitals and endoscopy facilities in their transition to newer scopes pending market entry.
“We recognize that an immediate transition away from conventional duodenoscopes to the newer, innovative models will take time due to cost and market availability,” the agency further notes. “We encourage health care facilities purchasing new duodenoscopes to begin developing a transition plan and work to replace their conventional duodenoscopes with newer models.”


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