Following years of issues relating to their sterilization and reuse, the FDA is now recommending that devicemakers and healthcare facilities transition to new types of duodenoscopes—specifically, those with disposable components—in order to reduce the risks of transmitting infections to patients.
The agency named several models from Olympus, Fujifilm and Pentax as ones to avoid in the future, all designed with fixed, rigid end caps. These can contain tight crevices that can be difficult to fully clean and may harbor potentially dangerous infections between uses.
Instead, the FDA is urging duodenoscopes be designed with single-use caps that eliminate the need for reprocessing and allow improved access to the device’s interior for cleaning. The first duodenoscope with a disposable plastic end cap, Pentax’s ED34-i10T, was cleared in September 2017; Fujifilm has since received clearance for a similar model.
For the future, the agency recommends the industry move toward fully disposable duodenoscopes once they become available.
“We recognize that a full transition away from conventional duodenoscopes to innovative models will take time and immediate transition is not possible for all health care facilities due to cost and market availability,” Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in an agency statement.
“This is why we’re communicating with health care facilities now—so they can begin developing a transition plan to replace conventional duodenoscopes—and those facilities that are purchasing duodenoscopes with fixed endcaps can invest in the newer, innovative models,” Shuren said. “We are also encouraging the manufacturers of these duodenoscope models to assist health care facilities with their transition plans.”
Though the overall risk of transmitting infections through reused duodenoscopes is relatively low, continuing reports of contamination have caused the agency to act, he added. Earlier this year, the FDA reported new surveillance data tracking infection rates linked to reprocessed devices from Olympus, Fujifilm and Pentax.
In April, the agency disclosed that 5.4% of samples tested positive for what it describes as “high concern” organisms—such as Escherichia coli or the bacteria related to staph infections—up from 3% detailed in a safety communication in December 2018.
According to the FDA, flexible duodenoscopes are used in more than 500,000 endoscopic procedures a year, including in the diagnosis of the pancreas and bile ducts. Reprocessing procedures can take hundreds of steps to remove bodily tissues and fluids as well as microorganisms.
“Information from postmarket surveillance human factors studies indicate that many steps in the reprocessing instructions cannot be reliably followed by health care facilities,” the agency said, referring to real-world studies required of Olympus, Fujifilm and Pentax, adding that users frequently had difficulty understanding and completing the manufacturers’ instructions.
Going forward, the FDA is ordering new postmarket studies of devices with disposable end caps to ensure the feature makes reprocessing instructions easier to follow and lowers contamination rates. The agency requested that real-world contamination rates be included in product labeling once those studies are completed.
"We are collaborating with the FDA and are supportive of their recommendation of a gradual transition to duodenoscopes with disposable components," an Olympus representative said in a statement to FierceMedTech. "Accordingly, we are diligently working on development of a disposable endcap duodenoscope and anticipate filing our submission to the FDA as soon as possible."
The FDA is not making any changes to the approval status of currently cleared devices and said that it believes the continued availability of fixed end cap devices is in the best interest of the public health at this time.
Meanwhile, the agency also issued letters to certain manufacturers of test strips used to assess the cleanliness and clear reprocessed duodenoscopes, saying their products have not gone through proper premarket review.
The agency said “it is aware that some health care facilities are using adenosine triphosphate, or ATP, test strips, to assess duodenoscope cleaning. These test strips claim to indicate the presence of live microbes inside of duodenoscopes. However, to date, the FDA is not aware of any legally marketed ATP test strips cleared by the agency for this use, which means the FDA has not reviewed them for effectiveness in assessing reprocessing.”
Editor's note: This story was updated with comments from Olympus.