Endoscopes again find their way onto the ECRI Institute

Preventing Infection

Reprocessing Once Again Makes Top Health Tech Hazards List

Failure to adequately reprocess contaminated duodenoscopes between uses is known to spread deadly pathogens, according to new ECRI survey data.

The ECRI Institute’s list of the top 10 health technology hazards for 2022 includes poor duodenoscope reprocessing ergonomics and workflows that put healthcare workers and patients at risk.

Correcting these problems will require, among other strategies, “reevaluating the use of reusable duodenoscopes.”

Duodenoscope reprocessing comes in at No. 8 among the top 10 hazards on the ECRI list. The closely watched rankings are released annually and designed to help inform healthcare facilities and workers of risks and how to manage them.

Failure to adequately reprocess contaminated duodenoscopes between uses is known to spread deadly pathogens, according to new ECRI survey data. Less well known, the report’s authors write, are the risks of injury to reprocessing staffers, “and the ways in which ergonomic and workflow factors can compromise reprocessing effectiveness, putting patients at risk.”

The ranking follows an updated recommendation from the U.S. Food and Drug Administration (FDA) stating that healthcare facilities transition to duodenoscopes that pose less risk to patient safety, including versions with disposable endcaps and fully disposable varieties.

The list focuses on what ECRI calls “generic hazards” — problems stemming from using certain types or combinations of medical technologies, not specific models or suppliers. ECRI engineers, scientists, clinicians, and other patient safety experts identify topics for consideration and analyze the topics and whittle the list down to the final 10.

ECRI’s top selection was cyberattacks. Supply chain shortfalls and damaged infusion pumps followed at second and third on the list.

Duodenoscopes — flexible, lighted tubes that are threaded through the mouth, throat and stomach into the top of the small intestine (duodenum) — are used in more than 500,000 endoscopic retrograde cholangiopancreatography (ERCP) procedures a year in the U.S. This potentially life-saving procedure is critical to diagnosing and treating problems in the pancreas and bile ducts.

The FDA has cleared at least six duodenoscopes with disposable components that facilitate reprocessing, including the single-use duodenoscope developed by Ambu A/S, the Ambu ® aScope™ Duodeno.

Flexible endoscopes made the ECRI list every year from 2010 to 2020, with cross-contamination threats topping their list in 2010 and 2016.

Click here to read the ECRI executive summary.


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Endoscope-Related Infection: A Look to the Future
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Exogenous infections relating to contaminated endoscopes have been historically difficult to quantify. A recent systematic review offers a look at potential solutions to reducing the risk of patient infection from cross-contamination.
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Endoscope reprocessing involves a complicated series of between 50 and 100 steps depending on the device instructions for use and society guidelines adopted by the institution. Among the dozens of steps needed are several PPE changes to protect the integrity of the cleaning process.
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