Existing endoscope reprocessing practices may not be adequate to keep patients safe.

Preventing Infection

Comprehensive Review of FDA Adverse Event Reports Involving Flexible Endoscopes Investigates Reprocessing Effectiveness

“With the emergence of organisms resistant to multiple classes of antibiotics and antimicrobials — what we call today ‘superbugs’ — along with an aging population who can benefit from treatments that involve use of a flexible endoscope but whose immune systems are less active, the game has changed, the runway shortened."

A recent database analysis of medical device reports submitted to the U.S. Federal Food and Drug Administration (FDA) primarily by manufacturers between 2014 and 2021 documents multidrug-resistant bacteria on six types of flexible endoscopes, suggesting that current endoscope reprocessing practices may not always be sufficient to prevent contamination.

That analysis of the so-called MAUDE database, by Dr. Lawrence Muscarella, focused on colonoscopes, duodenoscopes, gastroscopes, bronchoscopes, ear-nose-throat “(ENT)” scopes and urological endoscopes, sold by a variety of manufacturers.

His study included the detailed review of more than 10,000 adverse event reports, and as many as 15,000 reports or more, submitted to the FDA beginning in 2014, describing contamination of a reprocessed flexible endoscope deemed “patient-ready.” Several of these reports associated the contamination with patient infections and bacterial outbreaks.

Muscarella is a national authority on the causes and prevention of healthcare-associated infections and is an Ambu consultant. A New York Times article recently described him as a researcher “who scours medical device reports submitted to the F.D.A. and has often been the first to identify infection risks.”

“This analysis’s findings underscore the importance, consistent with FDA guidance, of meticulously cleaning and performing at least high-level disinfection (on) flexible endoscopes in accordance with current infection control guidelines and the manufacturer’s reprocessing, handling and storage instructions, as well as assuring quality and safety measures are in place to prevent the use of damaged flexible endoscopes on patients, which can pose an infection risk,” Muscarella writes.

For each of the six studied endoscope types, the number of adverse event reports submitted to the FDA in 2021 exceeded significantly those submitted in 2014, with gastroscopes showing the most pronounced increase, Muscarella’s research found.

While federal officials have recently alerted the public about the risk of reprocessed bronchoscopes, urological endoscopes and duodenoscopes remaining contaminated, none of the alerts have advised the public of the risk of reprocessed gastroscopes remaining contaminated with multidrug-resistant organisms, including those models featuring an ultrasound transducer and elevator mechanism. Muscarella encourages the publication of evidence-based recommendations and guidance that reduce this risk.

The safe cleaning and disinfection, known as reprocessing, of all types of reusable endoscopes is critical to public health, since millions of procedures using endoscopes are performed annually in the U.S. Cross-contamination from patient-ready endoscopes, while rare, is a concern because studies show reprocessing does not guarantee 100 percent removal of all organisms from scopes, even when all guidelines are followed.

Muscarella found several factors that can increase risk of a reprocessed endoscope remaining contaminated:

  • the complex physical design of the endoscope
  • improper cleaning and/or inadequate storage
  • mishandling of the endoscope
  • endoscope damage
  • a faulty or loosened device component
  • faulty repairs and/or improper device servicing and maintenance

“With the emergence of organisms resistant to multiple classes of antibiotics and antimicrobials — what we call today ‘superbugs’ — along with an aging population who can benefit from treatments that involve use of a flexible endoscope but whose immune systems are less active, the game has changed, the runway shortened,” Muscarella told Infection Control Today in a story about his analysis. “The risk of endoscopes transmitting diseases is no longer academic but at times, fortunately still with low frequency, can be a matter of life and death.”

Reviewed cases link infections of multidrug-resistant bacteria to each of the six studied endoscope types. Cases linked infections specifically of CRE (carbapenem-resistant Enterobacteriaceae) to each of the three studied GI endoscope types, as well as to bronchoscopes, Muscarella found.

Muscarella’s detailed study also emphasizes the importance of healthcare providers routinely communicating with manufacturers, along with periodically reviewing FDA safety databases and the literature, to learn proactively about newly discovered potential safety risks associated with the design and contamination of flexible endoscopes and related devices.

Antimicrobial resistance is considered a global public health threat since mortality of patients infected with a “superbug” can be 50 percent or higher.

A recent study attributed an estimated 1.27 million deaths globally in 2019 to drug-resistant bacteria.

In April, the FDA updated a safety communication on duodenoscopes recommending that hospitals and endoscopy facilities “complete transition to innovative duodenoscope designs” due to concerns about reprocessing and patient cross-contamination.

Infection prevention and cross-contamination gained new attention in June 2021 with an FDA safety communication recommending that healthcare providers consider single-use bronchoscopes when there is increased risk of infection, with COVID-19 patients, or when immediate reprocessing is not available.

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