Who Are the Key Stakeholders in Gastroscope Safety?

Patient Safety

Who Are the Key Stakeholders in Gastroscope Safety?

“Manufacturers of colonoscopes and gastroscopes might want to take a page out of that duodenoscope remedy and consider how we can enhance the cleaning of that air/water nozzle at the distal tip of these GI endoscopes.”

Three primary stakeholders may play a role in protecting patients from the infection risk associated with reusable gastroscopes: healthcare providers, endoscope manufacturers and the U.S. Food and Drug Administration.

Dr. Lawrence Muscarella, a national authority on the causes and prevention of healthcare-associated infections, offered advice to those stakeholders on the Transmission Control podcast in the third episode of a three-part series on gastroscope safety signals.

To healthcare providers:

Muscarella — an Ambu consultant — recommends GI endoscopy units be made aware of the risks gastroscopes possess in exposing patients to CRE and other multidrug-resistant organisms (MDROs). Departments should enhance training and education for reprocessing staff and stress the importance of proper cleaning of the air/water nozzle.

Additionally, he suggests flushing water through scope channels immediately after each procedure according to manufacturer’s instructions for use. Doing so will help to dislodge debris inside of the gastroscope and reduce bioburden buildup prior to reprocessing.

Lastly, Muscarella says to perform periodic reviews of reprocessing practices to confirm they adhere to all policy and procedures.

To gastroscope manufacturers:

Muscarella suggests looking back to a series of FDA communications beginning in 2019 that recommend both providers and scope manufacturers transition away from traditional duodenoscope models toward novel designs that feature disposable components or are fully disposable.

“Manufacturers of colonoscopes and gastroscopes might want to take a page out of that duodenoscope remedy and consider how we can enhance the cleaning of that air/water nozzle at the distal tip of these GI endoscopes,” he said.

To the FDA:

Muscarella recommends the agency consider issuing communications warning of risks reusable gastroscopes possess in exposing and infecting patients with CRE or other MDROs, as it has with other types of endoscopes.

“The FDA has done that in the last couple of years for urological endoscopes, bronchoscopes and duodenoscopes,” he says. “I recommend FDA consider doing it also for gastroscopes. I think it’s a really important measure, step and action to significantly improve patient safety.”

The first two episodes in the series included an overview of gastroscope contamination risks and an analysis of their safety signals. Muscarella recently wrote about a report linking two gastroscopes to three patients who tested positive for a rare strain of antibiotic-resistant E. coli bacteria as well as other adverse events involving reprocessed gastroscopes.

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