The endoscope disinfecting process could use some oversight from infection preventionists, says one manager of a global endoscope manufacturing company.
It’s an idea that seems to be gaining traction in IP job descriptions these days, Melinda Benedict, senior manager of infection prevention at Olympus, recently told Infection Control Today.
“There’s a lot of room in endoscope reprocessing for infection preventionists to really come in and offer their really unique perspectives,” Benedict said. “I always recommend that a facility pull in their IPs because the IPs really fill a knowledge gap that other areas and other people in your facility may not have.”
The U.S. Food and Drug Administration has issued safety alerts in several therapeutic areas related to cross-contamination in recent years. In August 2019, the FDA recommended an industry-wide switch to partially or fully disposable duodenoscopes.
The recommendation was an effort to curb exogenous infection transmission during endoscopic retrograde cholangiopancreatography (ERCP).
Olympus recently released a new duodenoscope with a disposable end cap that enables sterile processors to better access some of the small, mechanical areas of the scope, Benedict said. Her company had received FDA clearance for a fully disposable version, the EXALT Model D single use duodenoscope, in 2019.
That same year, Ambu received clearance for its single-use Ambu® aScope™ Duodeno.
Reusable duodenoscopes are considered one of the most difficult endoscopes to clean and disinfect because of their multiple channels and an elevator mechanism on the distal end.
In June 2021, the FDA recommended that facilities consider using sterilization rather than high-level disinfection for bronchoscopes where feasible and consider using a single-use bronchoscope when there is increased risk of spreading infection or when there is no immediate support for reprocessing.
While the risk of device-related infection is considered to be rare, that FDA safety communication updated years of investigation into medical device reports (MDRs) related to bronchoscope-associated infection. The agency collected 867 MDRs between July 2015 and January 2021, an almost eightfold increase compared with the 109 bronchoscope-related MDRs from January 2010 to June 2015.
“Reprocessing is sort of a flawed process in general, whether that’s due to personnel issues, the device itself, the equipment that’s used within that process — there’s lots of different ways that this process can sort of go off the tracks,” says Dr. Hudson Garrett Jr., an infection prevention expert in a webinar explaining that FDA safety communication.
Given the high stakes, infection preventionists can offer a powerful, fresh perspective.
Improving infection prevention programs, standardizing metrics, and better controlling potential HAI events are among the goals which must be accomplished, infection prevention leaders said recently at the Association for Professionals in Infection Control and Epidemiology (APIC) annual conference.
“The infection preventionist can really go in almost as a consultant and consult on [whether the instructions for use are] being followed as written,” Benedict said. “If the departments that are handling endoscopes aren’t inviting the IPs in, I think the IPs should really be proactive and seeing if they can reach out to help.”