Sept. 21 (UPI) -- The U.S. Food and Drug Administration has cleared the first duodenoscope with a disposable distal cap for use in the upper gastrointestinal tract.
Duodenoscopes are used in more than 500,000 procedures annually in a less invasive way than surgery to drain fluids from pancreatic and biliary ducts blocked by cancerous tumors, gallstones and other GI tract conditions.
Duodenoscopes are threaded through the mouth of a patient into the top of the small intestine with several small working parts that make cleaning difficult. If the device is not cleaned properly and thoroughly, contaminated tissue or fluid can be trapped, allowing for the transfer of bacteria between patients, leading to infection.
The FDA approved the Pentax ED34-i10T model duodenoscope, the first duodenoscope with a disposable distal cap that will improve access for cleaning and reprocessing of the duodenoscope.
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"We believe the new disposable distal cap represents a major step towards lowering the risk of future infections associated with these devices," Dr. William Maisel, acting director of the Office of Device Evaluation in the FDA's Center for Devices and Radiological Health, said in a news release. "Improving the safety of duodenoscopes is a top priority for the FDA, and we encourage companies to continue to pursue innovations that will help reduce the risk to patients."
The FDA previously issued a Safety Communication to healthcare professionals about a design problem with an earlier version of the Pentax duodenoscope ED-3490TK. Cracks and gaps could form in the adhesive that seals the scope's distal cap onto the scope, possibly allowing fluids and tissue to leak into the duodenoscope.
The new version's single-use distal cap protects against infection from reuse and has improved interface, ergonomics, image quality and a reduced length.
