The news, released yesterday, comes about a week after FDA announced clearance of the Pentax duodenoscope. The DEC HD duodenoscope has been available in global markets since 2017.
The disposable elevator design reduces the number of parts requiring cleaning and disinfection between uses, according to the FDA. The agency has recommended that healthcare providers move toward duodenoscopes that can be more easily sterilized, after post-market surveillance again found higher-than-expected contamination rates of “high-concern organisms.”
In April the FDA revealed new data showing that rates of so-called “superbug” infections were nearly twice as high as previously thought in duodenoscopes. Reports of deadly superbug outbreaks related to the devices started cropping up in 2015.
“Duodenoscopes with a disposable elevator component represent another major step toward lowering the risk of infection among patients who undergo procedures with these devices,” director of the FDA’s Center for Devices & Radiological Health Dr. Jeff Shuren said in a news release.
Pentax’s DEC HD device is meant to allow physicians to simply and safely dispose of the elevator with a sterile, disposable distal cap, as well as a lightweight, ergonomic control body. It is designed to aid in diagnoses, visualize mucosa in detail, identify abnormal tissue and locate papilla for cannulation.
“The DEC represents a significant clinical innovation both in device design and patient safety due to its sterile and disposable distal end cap with integrated elevator, and also a human factors-validated approach to both reprocessing and competency-based training,” Pentax global chief clinical officer Dr. Hudson Garrett said. “The DEC was specifically designed in response to the evidence-based recommendations released by the FDA and CDC and represents a critical step forward in improving patient safety, reducing contamination, and optimizing endoscope reprocessing programs.”