FDA clears Olympus duodenoscope with additional cleaning tools
Following the FDA’s successive clearances of new, reprocessing-conscious duodenoscope designs from Pentax Medical and Boston Scientific late last year, competitor Olympus Medical has now received a green light of its own.
The agency cleared the company’s TJF-Q190V duodenoscope featuring a clear, disposable endcap. Removing the single-use cap allows for easier access and cleaning of the device’s complex elevator components, where bacteria and biomatter have been known to survive sterilization processes and pass infections on to the next patient.
The clearance also covers a new, proprietary flushing adapter used for further cleaning of the scope’s elevator mechanism—as well as water-resistant scope connectors and sealed elevator wire channels that minimize the risk of bodily fluids reaching the innards of the device.
"Infection prevention is an ongoing mission that we at Olympus are committed to fulfilling, working in partnership with our customers, medical societies, and regulatory authorities to keep patients safe while providing physicians the most advanced tools and technology for accurate and effective diagnosis and treatment," said Kurt Heine, vice president of Olympus’ endoscopy group.
Additionally, the company said it would perform periodic inspections and maintenance of each device sold, based on the frequency of its reprocessing, to examine whether normal wear-and-tear affects the function of the scope or its ability to be thoroughly cleaned.
"A goal of our innovation is to expand the capabilities of our physician customers while making it easier to achieve patient safety standards," said Ross Segan, chief medical safety officer of Olympus’ U.S. division. "The further into the body we can go with minimally invasive equipment, the more power we will have to diagnose life-threatening conditions and treat them, which can lead to critical benefits, including reduced costs and improved patient outcomes and satisfaction."
Last November, Pentax Medical received the first FDA clearance for a scope designed with a completely disposable head, including its elevator components. A month later, Boston Scientific brought forward its fully disposable duodenoscope, in a world first.
The FDA had previously called out several endoscope models from Olympus, Fujifilm and Pentax as products to avoid, which had come with fixed, rigid end caps that made the devices notoriously difficult to clean.
Agency data from safety surveillance studies of contamination rates has shown up to 5.4% of sampled reusable devices tested positive for serious infections such as E. coli and Staph, carrying the potential to cause fatal outbreaks.