We’re on a mission to eliminate high-level disinfection. Anyone who has seen closeups of the crud, corrosion and contaminants left behind on a reprocessed scope knows that we need to shift from GI scope disinfection to terminal sterilization. If we here at the Altru Health System in Grand Forks, N.D., have any say in the matter, that shift will happen sooner than later. A lot sooner.

A few months ago, we became the first-ever facility to sterilize GI scopes. It was a big deal, for sure, not just for our central sterile department, but for every reprocessing room in every surgery center and hospital. A new low-temperature sterilizer from TSO3 made this possible. The Sterizone VP4 uses dual sterilants — vaporized hydrogen peroxide (H2O2) and ozone (O3) — to achieve terminal sterilization of heat- and moisture-sensitive medical devices. In the same amount of time it takes to high-level disinfect, we can terminally sterilize multi-channeled flexible endoscopes (with a maximum of 4 channels) of up to 3.5 meters in length, such as video colonoscopes, duodenoscopes and gastroscopes. We’re starting off sterilizing duodenoscopes, the most challenging scope to reprocess (only my 5 highest-paid reprocessing techs can clean duodenoscopes). From there, we’ll sterilize gastroscopes and colonoscopes.

What’s more, the Sterizone VP4 can run mixed loads, which minimizes the time we spend sorting instruments and maximizes device turns. In the same cycle, we can process a mixed load of general instruments, single-channel flexible endoscopes, and single- or double-channel rigid endoscopes, with load weights of up to 75 lbs.

Scope sterilization

We can really get behind our low-temp sterilizer’s slogan: A sterile device for every patient. There’s really no comparison between a high-level disinfected scope and a sterilized scope. Sterilization eradicates all living organisms, including bacterial spores, while disinfection gets rid of only bacteria and viruses. Only sterilization (or disposable scopes) prevents scopes and all other devices from transmitting infectious disease, providing the safety margin our patients deserve.

We all know the shortcomings of endoscope reprocessing. It’s highly complex and unreliable. You have to stay within a certain temperature range, use the reprocessed scope within a date range and validate that the scope is devoid of microbial contamination. Plus, the microbial load of GI endoscopes is such that even if you clean and disinfect with perfection, there’s still some level of contamination after processing.

GI scopes are the most complex surgical device to reprocess — complex not just in design, but also in the reprocessing process.

• Design. A long list of design features predispose heat-labile endoscopes to disinfection failures — their long (3.5ft), narrow (1mm to 3mm) lumens, right-angle bends, rough or pitted surfaces, and springs and valves. Damaged channels may impede microbial exposure to high-level disinfection.
• Process. With as many as 150 manual steps — and fail points along the way — how many steps will your tech complete … and complete correctly? Leak test, disassemble scope completely, brush all endoscope channels and components, immerse scope and components in detergent. Flush endoscope with detergent, rinse endoscope with water, purge endoscope with air, load and complete automated cycle for high-level disinfection, flush endoscope with alcohol, use forced air to dry endoscope and wipe down external surfaces before hanging to dry.

The margin of safety with endoscope reprocessing is said to be so small that perfection is required. Perfection? That’s a bet not worth making and a risk not worth taking — not when we know that the use of a contaminated endoscope may lead to patient-to-patient transmission of pathogens with a subsequent risk of infection.

“If the margin of safety is so small that perfection is required, then the design is too complex and the process is too unforgiving to be practical in a real-world setting,” says noted epidemiologist William A. Rutala, PhD, MPH, CIC, a research professor of medicine at the University of North Carolina at Chapel Hill.

Revamped reprocessing

Sterilization is just one way we’ve overhauled our scope reprocessing process in recent years. Here’s what else we’ve done.

• Ergonomic equipment. We made a huge investment in ergonomic equipment for our reprocessing techs, including height-adjustable sinks, automated instrument flushers, instrumentation tables in the clean room and easy-to-push case carts. In the 2½ years before I came on board, our 25 central sterile employees suffered 50 work-related injuries. That’s right, on average, we injured every employee twice. Staff were subjected to back, shoulder and repetitive stress injuries. They broke their hands on the washer racks and smashed fingers between case carts. Last year, we did not have a single missed-day work injury.
• Make reprocessing a career, not a job. We had a huge human resources problem in our reprocessing department. A position would come open and we would not have a single applicant. And we had plenty of vacancies — we had 100% turnover within 1 year. Part of the problem was that we didn’t consider reprocessing to be a professional position. We paid techs less than our environmental services department, less than starting wages at McDonald’s. All that’s changed. Our pay rates are some of the highest in country. We pay 2 pay grades below a surgical tech. We have 5 technical pay grades for sterile processing techs. We created a career ladder that lets techs advance with training and experience. We treat our reprocessors as technicians as opposed to support services staff. We are a service excellence department, not a dishwashing operation. What a 2-year turnaround it’s been. We’ve created a long-term, highly sustainable reprocessing staff. Our turnover rate is 13%. We have 65 central sterile employees (45 FTEs) covering our main hospital, a secondary specialty 4-OR orthopedic hospital, a rehab hospital and a soon-to-open surgery center.
• Cleaning verification. You can’t sterilize a device that’s not clean. Whether we’re disinfecting or sterilizing our duodenoscopes, we run 3 cleaning tests to verify that we passed the manual clean: swab of distal tip, flush of channel, swab of elevator. If any of those tests don’t pass, we reclean it. In 20 months, we’ve had 1 positive culture, which was a waterborne contaminant.

We visually inspect the inside of every GI scope with a borescope and test for residual proteins at the end of the manual clean using ATP testing. We inspect the exterior of a device with a magnifier.

Impact statement

If we can eliminate a surgical site infection or an employee injury due to our efforts, that’s where the impact is. Every member of our C suite has been through my department. We make them watch how complex it is to reprocess an endoscope, how strenuous it is to stand over the sink in full PPE, in the water, in the heat, for 8 hours. OSM