November 20, 2019

FDA on Friday announced it has granted Pentax approval to market a duodenoscope with a sterile, disposable elevator—an innovation that reduces the number of parts that need to be cleaned, potentially lowering the odds of transmitting dangerous superbugs.

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Background

Scopes help physicians inspect the digestive tract, respiratory system, and other areas of the body without resorting to surgery. However, the devices also can be a vector for infection. To clean scopes, which contain sensitive equipment such as lights and cameras, health care providers must use disinfectants and carefully brush and wash the products.

But some pathogens make it through the cleaning process. FDA in 2013 learned about a potential link between multi-drug resistant bacteria and scopes—even those that were properly sterilized and disinfected based on the instructions from manufacturers. According to FDA, as many as 350 patients at 41 medical facilities across the globe were infected by or exposed to contaminated gastrointestinal scopes between 2010 and 2015. Contaminated scopes had killed at least 35 patients in the United States from 2013 to January 2017.

FDA in 2013 started to collaborate with duodenoscope manufacturers FujifilmOlympus, and Pentax to address contamination risks. In 2015, the agency ordered the companies to conduct post-market surveillance studies to assess whether health care professionals can properly clean and disinfect duodenoscopes. FDA also ordered the companies to evaluate whether hospital professionals are adequately trained to follow reprocessing instructions.

In August 2019, FDA issued a safety statement that advised health care facilities and manufacturers to transition to duodenoscopes with disposable endcap components to help reduce the spread of infection between patients.

Approval details

FDA on Friday approved Pentax's Medical Video ED34-i10T2 model duodenoscope, marking the first time FDA has approved a duodenoscope with a sterile, disposable elevator component, the agency said in a release.

According to FDA, the device is intended to be used with endoscopic devices to provide doctors with a video monitor of and therapeutic access to the biliary tract through the upper gastrointestinal tract. FDA said risks of using the device include but are not limited to burns, electric shock, perforation, infection, and bleeding.

According to MedPage Today, the device represents "a major milestone on the road to eliminating contamination problems associated with such devices." Previous research has shown that the elevator component is a common hiding place for germs, as sterilants and mechanical cleaning cannot always reach germs in elevator component, MedPage Today reports.

Jeff Shuren, director of FDA's Center for Devices and Radiological Health, in a release said, "Duodenoscopes with a disposable elevator component represent another major step toward lowering the risk of infection among patients who undergo procedures with these devices." He continued, "We encourage manufacturers of these devices to continue to pursue innovations that will help reduce risk to patients, and also encourage hospitals and other health care facilities where these procedures are performed to begin or continue transitioning to devices with disposable components that are easier to reprocess" (Anderson, Becker's Hospital Review, 11/15; Gever, MedPage Today, 11/15; Mishra, Reuters, 11/15; FDA release, 11/15).

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