Reusable Gastroscopes Linked to Superbug Infections in Three Patients

Preventing Infection

Reusable Gastroscopes Linked to Superbug Infections in Three Patients

“These findings, in addition to other published data, raise reasonable questions about whether the risk of a reprocessed gastroscope remaining contaminated and exposing patients to a MDRO is sufficiently recognized today, and whether additional updated measures may be necessary to improve awareness and enhance gastroscope safety.”

A report filed with the U.S. Food and Drug Administration in November 2022 links two gastroscopes to three patients who tested positive for a rare strain of antibiotic-resistant E. coli bacteria.

It’s unclear if the patients were cross-infected with the gastroscopes. Dr. Lawrence F. Muscarella, a national authority on the causes and prevention of healthcare-associated infections and related errors, described this report and others involving reprocessed gastroscopes in a blog post earlier this month.

“The safe use of gastroscopes is crucial to public health and to preventing patient infections,” he writes. “As many as 6 million procedures are performed annually in the U.S. using a gastroscope.”

Muscarella is an Ambu consultant and the company provided some of the funding for the research. The company did not edit or revise Muscarella’s post before publication.

The second report Muscarella details was filed in July 2021: Six patients developed the same strain of carbapenemase-producing Pseudomonas aeruginosa (CPPA) in a six-month span following procedures performed with the same gastroscope. Three patients died, though their deaths were not known to be associated with the reprocessed gastroscope. The report found no breaches in high-level disinfection processes.

Muscarella additionally described a third case from 2016 in which six carbapenem-resistant Klebsiella pneumoniae cases involved ICU patients who had been exposed to the same gastroscope. Once again, the report identified no reprocessing deficiencies.

In all three reports, the culturing performed on the identified gastroscopes came back negative.

Muscarella writes that many other adverse event reports describe contaminated gastroscopes without associated cases of patient infection. Such cases “indicate an infection risk, warranting prompt attention and often necessary corrective action to improve safety.”

Muscarella published an analysis last year that found the number of relevant adverse event reports submitted to FDA between 2014 and 2021 was greatest for gastroscopes. The analysis included bronchoscopes, colonoscopes, duodenoscopes, ear-nose-throat (ENT) and urological endoscopes. Gastroscopes also saw the most pronounced increase in reports over the seven-year span.

“These findings, in addition to other published data, raise reasonable questions about whether the risk of a reprocessed gastroscope remaining contaminated and exposing patients to a MDRO is sufficiently recognized today, and whether additional updated measures may be necessary to improve awareness and enhance gastroscope safety,” Muscarella writes.

He recommends “publication of federal safety notices featuring updated guidance to raise awareness” toward the risk of infection associated with reprocessed gastroscopes. The FDA has issued such alerts regarding reusable bronchoscopes, duodenoscopes and urological endoscopes.

More Gastroenterology Articles
AAMI Responds to GI Societies’ ST91 Rebuttal
Gastrointestinal Endoscopy Applications
A group of GI societies voiced concerns over the updated reprocessing guidelines, particularly their length, redundancies, disparate definitions, and conflicting recommendations.
Reviewing the Efficacy of Duodenoscope Reprocessing Techniques
Prevention Challenges
A literature review finds current duodenoscope reprocessing measures to be inadequate and explores several promising novel developments.
More From Single-Use Endoscopy
Free Resources to Celebrate the 10th Anniversary of GI Nurses and Associates Week

Gastrointestinal Endoscopy Applications

The society provides you with a list of ideas to recognize the GI nurses in your department.

Patient Safety Awareness Week is a good opportunity to rethink infection prevention practices.

Patient Safety Awareness Week

Errors or instances of preventable harm in healthcare can have a wide range of physical, emotional, and financial effects on patients, according to the IHI, which is why the organization recognizes Patient Safety Awareness Week annually.

Patient success stories may help healthcare workers overcome burnout.

Critical Care

Post- ICU clinics designed to help patients recover from critical illness may serve the dual purpose of helping their caregivers overcome burnout, according to a new study.