With all of the difficulties in cleaning duodenoscopes, and the potential for outbreaks of carbapenem-resistant Enterobacteriaceae (CRE), some outpatient surgery managers are questioning why these scopes are approved by the Food and Drug Administration (FDA).

“While the design of the elevator mechanism has raised concerns over the years about the cleanability of these specialized scopes, until recently there has been somewhat limited evidence that duodenoscopes are not being effectively reprocessed when performed according to recommended methods,” says Chris Lavanchy, engineering director of the Health Devices Group at ECRI Institute in Plymouth Meeting, PA.

With the recent CRE outbreaks, providers and others have become aware that even if the devices are properly processed, that is no guarantee that they are free of microbes, Lavanchy says.

“Because CRE bacteria are relatively rare, and because infections associated with the bacteria can have a high mortality rate, the reports of CRE outbreaks associated with duodenoscopes have served as the figurative ‘canary in the coal mine’ and alerted the healthcare community that concerns about being able to adequately reprocess duodenoscopes may be warranted,” he says.

However, the benefits outweigh the risks, some sources say. Jennifer Corbett Dooren, a press officer at the FDA, says, “Duodenoscopes are critical to diagnosing and treating severe, often life-threatening diseases.”

Dooren points out that the devices have been used for decades and are used for endoscopic retrograde cholangiopancreatography (ERCP), which is the least invasive method used to treat blockages of the biliary and pancreatic ducts.

“Hundreds of thousands of patients with very serious conditions benefit from this important, life-saving procedure,” she says. “The risk of developing multidrug resistant bacterial infections following ERCP is low, whereas patients may encounter serious health risks from not receiving necessary treatment.”

Lavanchy concurs. “To put this into perspective, approximately 500,000 ERCP procedures are performed in the U.S. annually, and only a handful of CRE infections have been associated with the use of duodenoscopes each year,” he says. “So while the consequences of CRE infections can be very severe, the prevalence is very low.”

However, the FDA is reviewing validation data from each manufacturer marketing duodenoscopes in the United States, which includes FUJIFILM, Olympus, and Pentax, Dooren says. The FDA also is reviewing analysis of medical device reports, collecting information from manufacturers, interacting with the Centers for Disease Control and Prevention, obtaining information from the facilities where outbreaks occurred, and conducting an evaluation of the medical literature.

“In addition, the agency conducted an engineering assessment of the device, leading us to believe that the design of these duodenoscopes creates significant challenges for reprocessing,” Dooren says.

Resource

• Transcript of media briefing on Federal officials announce next steps on reprocessing of reusable medical devices, including duodenoscopes. March 12, 2015. Web: http://www.fda.gov/NewsEvents/Newsroom/MediaTranscripts/ucm434110.htm.