Disposable Device Protects Duodenoscope From Microbial Contamination

By Scott Baltic

April 14, 2020

NEW YORK (Reuters Health) - A new disposable device provides two-way microbial protection for a duodenoscope and does so without the need to change current equipment, technique, or work flow, a new study shows.

The single-use ScopeSeal features an optical lens covering the duodenoscope camera and light source; a port sealing around the duodenoscope's washing and insufflation nozzle; and a thin-walled, flexible tubular extension (working channel extension) that extends into the duodenoscope's biopsy channel. The latter seals the elevator area while preserving the elevator's ability to articulate devices.

After use and before reprocessing, the extension also enables flushing of the endoscope's biopsy channel, without exposing the elevator area to contamination.

ScopeSeal was cleared by the U.S. Food and Drug Administration last year for use on the Olympus TJF-Q180V duodenoscope, which is used in most endoscopic retrograde cholangiopancreatography (ERCP) procedures in the U.S. It accommodates devices up to 10.7 Fr in diameter, including papillotomes, stents and their delivery systems, and cholangioscopes, and is intended to be a lower-cost alternative to single-use disposable duodenoscopes.

"ScopeSeal is analogous to a physician wearing gloves, which along with vigorous scrubbing and washing before and after the procedure protects both the patient and the physician from contamination and potential infection," Scott R. Miller, CEO of GI Scientific, in Arlington, Virginia, the device's maker, told Reuters Health by email.

He added that the company is working to establish the pricing for ScopeSeal and that the device "will be a fraction of the cost of a disposable scope."

Even under ideal circumstances, Miller and his coauthors point out in Gastrointestinal Endoscopy, disinfection "cannot always eliminate microbes from the hard-to-clean duodenoscope distal end, nor is this procedure designed to yield sterile duodenoscopes."

An immersion test was performed on 14 ScopeSeals with fluorescent dye that's typically used for leak testing. This test found no evidence that the dye had passed the devices' barrier.

To test for outside-in protection against microbial contamination, three thoroughly disinfected duodenoscopes were fitted with ScopeSeals and exposed to suspensions of E. coli in fetal bovine serum, to simulate bacteria found on duodenoscopes after ERCP.

Use of the scope was simulated by articulating it back and forth five times, actuating the elevator five times, and passing an instrument down the working channel.

Following this test, no E. coli was recovered from the duodenoscopes tested.

To test for inside-out protection, the areas below the elevators of three duodenoscopes were contaminated with E. coli in fetal bovine serum, after which the duodenoscopes were fitted with ScopeSeals. A cleaning brush larger than a typical ERCP instrument was then passed three times through the working channel extension. No E. coli was recovered from the brush.

The ScopeSeal did not have a discernible effect on the optical performance of an Olympus TJF-Q180V.

Dr. Bret T. Petersen of the division of gastroenterology and hepatology at the Mayo Clinic, in Rochester, Minnesota, who was not involved in the study, told Reuters Health that to his knowledge, there's nothing on the market similar to the ScopeSeal.

The device's impact on clinical practice will depend on how well it functions and how durable it is during actual, sometimes lengthy, procedures, as well as its ease of use and cost, Dr. Petersen said by email, adding that he is looking forward to trying it out.

Dr. A.W. (Arjan) Rauwers of the Erasmus University Medical Center, in Rotterdam, the Netherlands, who has also studied endoscope contamination, said more research is needed to assess the new device's practical value.

For example, while the seal might offer protection against transmission of microorganisms from the elevator area, he told Reuters Health by email, "it has not been tested for transmission of microorganisms from the working channel," which often is also contaminated.

The study was funded by GI Scientific.

SOURCE: https://bit.ly/2JEJGBV Gastrointestinal Endoscopy, online March 6, 2020.