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.