The U.S. Food & Drug Administration (FDA) has announced it has cleared the first duodenoscope with a sterile, disposable elevator component: the Pentax Medical Video ED34-i10T2.
It is expected that the inclusion of such a component will help reduce infections associated with cleaning, disinfection and sterilization of duodenoscopes as the disposable component reduces the number of parts that must reprocessed between uses.
As Infection Control Consulting Services (ICCS) states in its recent special report on "10 of the Scariest Healthcare Infections and Threats," duodenoscopes have become synonymous with infections, some of which have contributed to patient deaths. Despite the issue receiving significant attention over the past several years, ICCS noted in April that duodenoscope reprocessing remains a significant infection prevention challenge. In August, FDA issued a safety communication advising hospitals and endoscopy facilities to transition away from fixed endcap duodenoscopes and begin using duodenoscopes with disposable components.
As Dr. Jeff Shuren, director of the FDA's Center for Devices and Radiological Health, states in an FDA release, "Duodenoscopes with a disposable elevator component represent another major step toward lowering the risk of infection among patients who undergo procedures with these devices. … We encourage manufacturers of these devices to continue to pursue innovations that will help reduce risk to patients, and also encourage hospitals and other healthcare facilities where these procedures are performed to begin or continue transitioning to devices with disposable components that are easier to reprocess."
In October, FDA cleared GI Scientific's ScopeSeal duodenoscope protective device. As the company notes, it is the first device for protecting the distal end of a duodenoscope from contamination during endoscopic retrograde cholangiopancreatography (ERCP) procedures. ScopeSeal is a single-use disposable device that sealings the infection prone distal end of the Olympus duodenoscope used in ERCP procedures.