Recently, the US Food and Drug Administration (FDA) approved for the first time a system for cleaning complex internal channels of flexible endoscopes, which are stubborn sources of hospital acquired infections. This breakthrough was achieved by Nanosonics' automated CORIS equipment.

It is reported that Nanosonics' CORIS device is specifically designed for stubborn biofilms formed in the narrowest areas of endoscopy. In the conventional reprocessing process, these areas cannot be touched by manual brushing. The residue composed of patient cells may gradually develop resistance to high-level disinfectants during multiple cleaning cycles.

This Australian company pointed out that research on gastroscopy and colonoscopy has found biofilm residues in the microchannels of all devices, and some outbreaks of hospital acquired infections can be traced back to specific antibiotic resistant strains carried inside these reusable instruments.

Previously, the FDA has urged medical technology developers and healthcare institutions to switch to endoscopic systems that contain disposable components (such as inner lens end caps) or are completely disposable, and has been tracking cases of instrument contamination and severe postoperative infections for many years.

It is worth mentioning that Nanosonics' CORIS disinfection system has passed the de novo clearance of the US FDA, and has been preliminarily approved for use in conjunction with Olympus' Evis Exera III electronic endoscope system designed specifically for colonoscopy. Meanwhile, the company stated that it plans to gradually cover all major categories of flexible endoscopes.

Nanosonics President and CEO Michael Kavanagh stated in a statement, "The company is continuing to advance commercialization preparations, including obtaining necessary approvals in the UK, Europe, and Australia. These approvals are expected to be completed in the first quarter of fiscal year 2026." At that time, the company will initiate the first phase of commercialization process centered around target hospital pilots.

At the same time, we are preparing to submit our first 510 (k) application for extended indications to the FDA Kavanagh added.

It is estimated that 60 million endoscopic treatments are required worldwide each year, with each operation relying on manual brushing and rinsing of the equipment inside, with over half of the cases occurring in the United States. In addition to CORIS, Nanosonics is also expanding into the ultrasound probe reprocessing equipment market through the Trophon series of products.
The CORIS system can be installed above the sink, injecting patented formula friction cleaner into the endoscope channel through an automated process, followed by air flushing and removal of internal residues. According to the manufacturer's instructions, the outer surface of the endoscope still needs to be cleaned separately according to standard procedures.

Source: https://news.yaozh.com/archive/45211.html