Originally published by our sister publication Gastroenterology & Endoscopy News

Adverse event reports submitted to the FDA, describing the actual or potential contamination of a reprocessed flexible endoscope, have increased significantly over the past seven years, according to a review and analysis.

The report, released in January by Lawrence Muscarella, PhD, the president of LFM Healthcare Solutions and a national authority on the causes and prevention of healthcare-related infections, included more than 10,000 adverse event reports describing contamination of a flexible endoscope submitted to the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database between 2014 and 2021. Dr. Muscarella focused on three GI endoscopes (colonoscopes, duodenoscopes and gastroscopes), as well as bronchoscopes, otorhinolaryngologic endoscopes and urologic endoscopes.

Although duodenoscopes have received particular scrutiny for their association with transmission of carbapenem-resistant Enterobacteriaceae (CRE) and other superbugs, the 804% increase in adverse event reports submitted to the FDA for these endoscopes was lower than for any other type of endoscope except bronchoscopes, which increased from 52 in 2014 to 259 in 2021 (or by 398%).

“Although FDA and others in recent years have diligently worked to reduce the contamination and infection risk of reprocessed duodenoscopes and other endoscope types, the findings of this analysis suggest that use of a duodenoscope remains a risk factor for patient exposure to multidrug-resistant organisms including CRE, warranting continued vigilance and care to ensure patient safety,” Dr. Muscarella wrote. “That said, this analysis found that the number of reports submitted to FDA linking a duodenoscope to patient deaths was significantly less in 2021 than just a few years ago.”

The analysis’s recommendations included the suggestion that healthcare providers consider “sterilization of gastroscopes (when feasible), or the use of a single-use gastroscope (when available and as warranted) to improve patient safety.” Dr. Muscarella recommended performing a risk assessment to help guide this consideration. He also recommended that health experts evaluate whether the issuance of a letter or alert informing healthcare providers of the risk for “reprocessed” gastroscopes transmitting multidrug-resistant bacteria, along with providing evidence-based practices that reduce this risk, is now warranted.

More Procedures, More Testing Led to Some Reports

Dr. Muscarella acknowledged that at least some of these increases in adverse event reports associated with endoscopes could be attributable to more procedures being performed and a higher level of vigilance that began in 2014 after U.S. health officials, for the first time, linked a duodenoscope at a single facility to multiple infections of CRE at a hospital in northern Illinois.

“On the heels of this and other outbreaks, the FDA ordered manufacturers to perform surveillance testing of duodenoscopes, and we’re seeing this type of testing being performed more now on other types of scopes, too. There also may be better compliance with medical device reporting regulations, so an increase in submitted reports does not necessarily translate into an increase in the contamination and infection risk,” he said. “Surveillance testing, in which endoscopes are randomly sampled and cultured after reprocessing without there necessarily being an infection or an outbreak, is more commonly being performed in hospitals today compared to years ago. If we don’t put something under the microscope to examine it, then we may never see its fine details. Now there’s closer examination of what’s going on.”

Potential Factors Impeding Cleaning and Disinfection

Dr. Muscarella described a few factors that he identified in reviewing the MAUDE reports that could interfere with the effectiveness of high-level disinfection and even sterilization. “With duodenoscopes, we learned that the complexity of their design can impede cleaning,” he said. “But another issue has to do with limited staff and financial resources and the problem of continuing to use a damaged endoscope unwittingly, or not maintaining, repairing and servicing instruments according to the manufacturers’ instructions and maintenance schedules.”

His analysis noted that several relatively recent adverse event reports discuss the deterioration of an adhesive, sealant or glue used at the distal end of some flexible endoscope types, causing a gap or crack to form in the adhesive and resulting in the potential for microbial contamination and an increased infection risk due to ineffective reprocessing. “In November of 2021, a duodenoscope model was recalled in part for this ‘adhesive deterioration’ phenomenon, but I found the problem is not unique to that one scope,” Dr. Muscarella said.

“There are stresses occurring at the distal end of the scope, which can be due to a number of factors including mishandling—like banging the endoscope inadvertently on a hard surface. This can cause cracking, chipping and gapping, almost like eating something hard and chipping an acrylic filling on your tooth, and then there’s a gap where bacteria could invade and accumulate. High-level disinfection of endoscopes is effective, provided certain criteria are satisfied, but the process can be challenging to achieve if the endoscope is damaged, a component becomes loose, the endoscope is particularly complex in design, or the endoscope is not sufficiently serviced and maintained.”

Need to Consistently Follow Manufacturers’ Guidelines

Dr. Muscarella’s findings with regard to gastroscopes are “troubling,” said Deepak Agrawal, MD, MPH, an associate professor of gastroenterology and hepatology at Dell Medical School at The University Texas at Austin. “If this is true, we would need to change what we are doing. But there are a few things that remain to be clarified. First, the MAUDE reports do not necessarily correlate contamination with infection, when patients are actually getting sick. Those things are very difficult to objectively prove with case reports, except for well-published case studies where they can trace one [type of] bacteria arising from the scope and see the same bacteria in other patients. In our practice, we do not see this.”

Dr. Agrawal also cited lapses in following manufacturers’ reprocessing guidelines. “It’s clear that there were breaches in protocol for some of these events,” he said. “What would these numbers look like if reprocessing guidelines were consistently followed the way they are written? Before we pursue something like sterilizing scopes or going to disposable scopes, which are cost-prohibitive and environmentally damaging, we should work further to mitigate risk with consistent reprocessing.”

Harish K. Gagneja, MD, FACG, AGAF, FASGE, a gastroenterologist with Austin Gastroenterology in Texas, agreed. “With gastroscopes and colonoscopes, we know that not much has been reported with regard to passive infections,” he said. “ERCP [endoscopic retrograde cholangiopancreatography] scopes are a different story because of the complex design, but this is an issue that can be addressed with more due diligence in cleaning and disinfection, and adequate storage. You must ensure that your reprocessing staff are adhering to manufacturers’ instructions and that you have proper storage units in your facilities.”

Dr. Muscarella agreed, recommending that GI endoscopy units routinely perform internal audits of staff practices to ensure infection prevention competency and endoscope reprocessing acumen.

Centers that maintain such strict protocols say they have not needed to pursue either sterilization or single-use endoscopes. “We are purchasing new colonoscopes shortly, and we are not going disposable,” said Linda Hubbard, RN, the director of nursing for the Endoscopy Center of Western New York. “We log every scope that is reprocessed and regularly review all of those logs, and ... have not had any infections for a number of years. Michelle Velez, our lead endoscopy technician, ensures that all of our reprocessing staff is up to speed on those competencies, and they are reviewed constantly. Precleaning starts immediately after each procedure is finished, and manual washing begins within one hour. We’ve been quite pleased with our processes, and I think having qualified techs who are dedicated to each procedure room and making sure there is no lag time have really helped us.”

—Gina Shaw

Drs. Agrawal and Gagneja and Ms. Hubbard reported no relevant financial disclosures. Dr. Muscarella reported a financial relationship with Ambu, which sponsored the MAUDE study.