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Preventing Infection

Why It’s Time for a ‘Paradigm Shift’ in Endoscope Reprocessing

Instrument reprocessing breaches are going to have greater consequences now than they did before, because a greater percentage of the bacterial transmissions are actually now being detected and reported as these serious infections.

As strains of bacteria once easily treated with antibiotics grow resistant to those drugs, their presence in patients after an endoscopy procedure can take a more dangerous turn.

Without antibiotics to fight them off, bacteria transmitted during a procedure with a reusable scope can become an infection with serious or even deadly consequences.

Larry Muscarella, president of LFM Healthcare Solutions LLC and an infection prevention expert, has been connecting the dots between endoscopes and infections for years. He appeared on a new episode of the Beyond Clean podcast called “Running Out of Runway: Building a Case for a Paradigm Shift in Endoscope Reprocessing” to share his insights on infection risks from reusable endoscopes and ways to make them safer.

“It may be that these previously harmless transmissions have now become insidious, serious infections,” he says. “It may be that the runway has run out and what we were getting away with before, we’re not getting away with now. It’s almost as if the antibiotics were masking the transmissions and those transmissions are now converting to infections and can no longer be masked.”

Hospitals have grown increasingly concerned, Muscarella adds, because they are seeing multiple patients with infections, with concerning bacteria.

“Instrument reprocessing breaches are going to have greater consequences now than they did before, because a greater percentage of the bacterial  transmissions are actually now being detected and reported as these serious infections,” he says.

Muscarella linked carbapenem-resistant Enterobacteriaceae (CRE) superbug infections to duodenoscopes in 2013. By February 2015, the U.S. Food & Drug Administration had notified the public of the potential for duodenoscopes to transmit the superbug CRE.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       

The FDA has asked manufacturers to include contamination rates in their labeling of duodenoscopes. That will enable doctors and patients to make more informed decisions about the potential risks associated with duodenoscopes, Muscarella says.

“Empowering the patient to make the decisions and to have full knowledge is what I think is going to be the key to solving these problems,” he says.

With all the media reports of contamination and infection, hospitals are confronting the dilemma of whether to shift from high-level disinfection, which they have practiced for decades, to sterilization — a transition many of them find overwhelming.

But, despite publicity around the infection risks from reusable duodenoscopes, not everyone acknowledges that endoscope contamination is a problem, Muscarella says.

“You would think it would be a slam dunk to move into the disposable realm,” Muscarella says. “But in some cases, users just prefer reusable devices, and in some cases the reason why they do is they just don’t think the system is broke, so there’s no reason to fix it.”

Ambu has received FDA clearance and will begin selling a single-use duodenoscope later this year. In the coming months, Ambu will introduce a sterile, single-use gastroscope and a single-use colonoscope and its next generation single-use bronchoscope.

Some reusable devices are more difficult to reprocess than others, perhaps harboring unseen internal damage or an inaccessible biofilm, he says.

“Just because it’s reusable and it has a set of [instructions for use] associated with it, does not mean necessarily that staff can easily follow those instructions, can easily complete those instructions or that even when performing those instructions, the desired outcome, namely a bacteria-free device, can be achieved,” he says.

Muscarella agrees that the design of duodenoscopes makes them more prone to infection transmission, but bronchoscopes share similar risk factors, he warns. Both devices can suffer from damage, inadequate manual cleaning, inaccessible biofilms and insufficient servicing, maintenance and repairs.

A 2019 survey found that a dozen “superbug” infections had been linked back to flexible bronchoscopes snice 2012. All the reported infections in that survey published in the October 2019 CHEST article “Bronchoscope-Related ‘Superbug’ Infections,” written by Muscarella and Dr. Atul C. Mehta of the Cleveland Clinic, were traced to flexible bronchoscopes that had been reprocessed, suggesting that current reprocessing guidelines and practices are not sufficient to prevent infections.

“More than any other device … the risk of them (bronchoscopes) transmitting these  multidrug-resistant bugs today is underrecognized, and it’s requiring greater discussion,” Muscarella says.

Click here for much more from Muscarella’s conversation with Beyond Clean.

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