FDA clears duodenoscope sheath for protection against infections

The FDA has given the green light to a disposable, sterile cover designed to reduce potential patient-to-patient contamination of duodenoscopes.

GI Scientific’s ScopeSeal device encloses the front end of the duodenoscope without disrupting its ability to see or perform endoscopic retrograde cholangio-pancreatography, or ERCP procedures, which are used to visualize issues in the liver, gallbladder, bile ducts and pancreas.

The device also seals the elevator area at the tip of the duodenoscope, where a lever raises or lowers tools during the procedure to collect samples or perform other tasks. These intricate moving parts are particularly prone to harboring bacteria and infections, and the recessed area can be difficult to clean and disinfect before the device’s subsequent uses.

To prevent biomatter from soiling the inside of the device, the ScopeSeal also provides a passageway that allows instruments to be passed through the scope without contacting the complex elevator area.

It is not, however, designed to replace the manufacturer’s cleaning and reprocessing procedures: GI Scientific compares its product to a surgeon donning gloves before an operation, alongside vigorous scrubbing and handwashing. 

The single-use ScopeSeal device
(GI Scientific)

RELATED: Too tough to clean: FDA urges industry transition to disposable duodenoscopes

The company estimates that more than 700,000 ERCP procedures are performed in the U.S. each year, and nearly 2 million globally. The FDA cleared ScopeSeal for use on the Olympus TJF-Q180V duodenoscope, which is used in about 85% of ERCP procedures in the U.S., and the device is compatible with instruments up to 10.7 French in diameter.  

In late August, the FDA urged devicemakers to transition to new types of duodenoscopes with disposable components to combat infection transmissions and recommended that healthcare providers avoid using devices with fixed, rigid end caps that are difficult to disinfect.

Those moves came after the agency reported new data from safety surveillance studies tracking contamination and infection rates related to reprocessed duodenoscopes—including increases in positive tests for “high concern” organisms, such as E. coli and staph infections. GI Scientific said significant outbreaks and deaths have been reported from drug-resistant infections linked to contaminated duodenoscopes.