Despite nearly four years of investigations, studies, redesigns, instruction updates and even lawsuits, federal health regulators warn that duodenoscopes are still testing positive for infectious materials, even after they’ve been properly cleaned between patients.
On December 10, the FDA issued a safety communication about the interim results of ongoing duodenoscope reprocessing studies, which have been conducted in real-world settings following a number of hospital infection outbreaks linked to the devices in recent years.
Duodenoscopes are used during endoscopic retrograde cholangiopancreatography (ERCP) procedures, but difficulties cleaning device manufactured by several different companies have resulted in reports of serious hospital infection outbreaks, typically involving aggressive, antibiotic-resistant “superbugs”, which have caused a number of severe injuries and deaths.
The safety of the devices first emerged after a duodenoscope infection outbreak at UCLA’s Ronald Reagan Medical Center in February 2015, involving carbapenem-resistant enterobacteriaceae (CRE) infections that resulted in at least seven infections and two deaths. At least 200 other patients had to undergo testing after being placed at risk by duodenoscopes manufactured by Olympus Corp.
The infections were linked to problems with the “reprocessing” instructions provided by the manufacturer, which are used to clean the devices for use by another patient. FDA reviewers determined that the instructions sent out at the time were inadequate and that even if the recommended steps were followed to clean ERCP endoscopes, flaws in the design may allow them to become easily contaminated.
In October 2015, the FDA ordered Fujifilm, Olympus and Pentax, the three manufacturers of duodenoscopes in the U.S., to conduct postmarket surveillance studies of the effectiveness of the cleaning instructions. The studies parameters called for a contamination rate of no higher than 0.4%. However, the studies reveal that three percent are contaminated with low-concern organisms, and three percent are contaminated with high-concern organisms that could cause serious infections.
The results are currently being analyzed in order to discover the root causes, the FDA safety communication indicates. The FDA is also issuing additional instructions to healthcare facilities and personnel on cleaning the devices.
Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, issued a statement indicating that health care professionals should closely inspect components that are difficult to clean, called the elevator recess, and repeat cleaning as long as debris is visible. he also called on health care providers to participate in the ongoing duodenoscope surveillance studies.
“However, it has become clear that following the manufacturer’s reprocessing and maintenance instructions, while critical, is not sufficient to avoid all infections associated with the use of duodenoscopes,” Shuren wrote in his statement. “That is why the FDA has also been working with developers on new product designs, including disposable components. Technological advances in product design hold promise to reduce the risk of contamination and enhance patient safety.”
The agency has approved a number of design changes over the last two years, and issued new standardized reprocessing protocols in February.
Several duodenoscope infection lawsuits have already been filed against Olympus over the infections linked to the UCLA outbreak, and it is possible that Pentax and FujiFilm will face similar cases. The complaints allege that design problems that make the scopes especially difficult to clean, placing patients at higher risk of contracting illness.
The FDA says it will continue to closely monitor links between duodenoscopes and infections.