When was the last time you were in your sterile processing department (SPD)?
With the implication that it probably was not recently, that was the question an infection preventionist (IP) asked attendees at the 2022 conference of the Association for Professionals in Infection Control and Epidemiology in Indianapolis.
“Surgical site infections are associated with a two- to 11-fold increase in risk of mortality,” said Kelley Knapek, MPH, BSN, RN, CIC, IP manager at Good Samaritan Medical Center in Lafayette, CO.1 “We know that improperly reprocessed instruments are associated with [an] increased risk of surgical site infection. Do you feel like you have a good understanding of your instrument reprocessing and are you confident that all areas that touch reprocessed instruments are working well together?”
Knapek found breakdowns and gaps in asking this question at her hospital, discovering that “infection prevention, sterile processing, the operating room, labor and delivery, and other areas where sterile instruments are used were operating in silos. Some things were slipping through the cracks until they became a bigger issue, and all departments were experiencing frustration and miscommunication.”
As a result, she reached out to the SPD, visiting and reviewing the entire process of decontamination, preparation and packaging, sterilization, quality control, and product distribution. Knapek then went to departments that were using sterilized instruments, looking for any breakdowns in the clean-dirty transport from the SPD.
“It might surprise you,” she said. “They’re going much further than your ORs (operating rooms) and your labor and delivery. You might find them in your emergency department, in your ICU (intensive care unit) or anywhere else.”
As part of the SPD inspection, list all machines and indications for use — “washers, disinfectors, sterilizers, ultrasonic cleaners, everything. Make sure you check out those manufacturers’ instruction for use. That’s what you’re going to be held to,” she said.
Recommending asking open-ended questions during walk-throughs, Knapeck suggested, “Tell me about what you’re doing here. How do you make sure that’s clean?”
As an extension of these visits, create a risk assessment analysis that includes identifying potential sources of sterilization failure.
“Estimate the likelihood that such a sterilization failure will occur, assess the consequences if [it] occurs, and assess how prepared the facility is to manage that failure,” she said.
In thinking about these potential breakdowns consider heating, ventilation, and air conditioning systems, water, inadequate cleaning and decontamination, failure of automated washers, and bioburden missed on manual inspection. Packaging of sterilized instruments may be inappropriate or incorrectly stored, she said.
Under Pressure
In short, SPD workers have a lot to think about and many feel the pressure of maintaining all quality functions throughout the rapid flow of instruments.
Another presentation at the APIC conference reported that many SPD workers are experiencing pain and ergonomic injuries, particularly as the emphasis on meticulous reprocessing of duodenoscopes has increased in recent years as a result of patient infections and deaths.
This goes beyond an employee health issue. IPs should be aware that any compromise of rigor in the SPD because of discomfort, pain, and injuries ultimately could affect patient safety.
In a survey done by the Emergency Care Research Institute (ECRI), 74% of 341 respondents answered “yes” to the question, “Do you experience fatigue or discomfort in any part of your body as a result of cleaning duondescopes?”2
“That concerned us,” said Amanda Sivek, PhD, a principal project engineer at ECRI. “By far, the area of greatest discomfort was the lower back, followed by the neck and shoulders.”
Sivek was joined by her co-researcher James Davis, MSN, RN, CCRN, CIC, a senior infection prevention analyst at ECRI.
There is a lot of pressure to reprocess quickly and keep the flow of devices and instruments moving, but the health and safety of workers and patients should also be given weight, he said.
“We need to give these folks time to do their jobs, and I’ll stand on that soapbox until it happens,” Davis emphasized. “They are doing a mission-critical task, and the safest thing to do to let them ‘breathe.’”
Although room design is being improved at many hospitals, small, cramped spaces have been the norm for central supply for too long, he added.
“We see this all the time when we do consults — there’s five people in a room that’s the size of a small janitor’s closet,” he said. “I’m not even exaggerating.”
The mental effects should not be discounted, since these workers feel “stuck in a box” and under time pressure to get instruments reprocessed. Although many manufacturers have excellent training programs, too many central supply workers are undertrained.
As IPs are no doubt aware, duodenoscopes are flexible tubes that run down through the mouth, throat, and stomach to the small intestine. They are used during endoscopic retrograde cholangiopancreatography (ERCP), a procedure to diagnose and treat pancreatic and bile duct diseases.
However, in the last several years, infections following ERCP procedures have been identified, some of them caused by multidrug-resistant organisms. Food and Drug Administration (FDA) investigations revealed that the devices cannot be reprocessed and sterilized with absolute safety, since they are of complex design and very difficult to clean.
A recent FDA safety communication renewed the urgency to this issue, saying two completely disposable duodenoscopes are on the market now and another five models have disposable parts to replace fixed endcaps that are hard to clean and can be a common source of pathogens.3
“Hospitals and endoscopy facilities should complete transition to innovative duodenoscope designs that include disposable components, such as disposable endcaps, or to fully disposable duodenoscopes,” the FDA stated. “The use of a removable component to facilitate cleaning leads to significantly less contamination; interim results from one duodenoscope model with a removable component show a contamination rate of just 0.5%, as compared to older duodenoscope models which had contamination rates as high as 6%.”
Duodenoscope manufacturers no longer market fixed endcap duodenoscopes in the United States, but they still are in use in many facilities, including the majority of those surveyed by ECRI. The FDA action does not recall these scopes, as some kind of transition time is going to be required with about 500,000 ERCP procedures performed annually in the United States. Money also is an issue.
“I would like to see it happen sooner, but we all know that we’re going to use these scopes until they’re unusable, because they cost a lot,” Davis said.
- Knapek K. Continuous quality improvement with sterile processing, perioperative services. Session V112. Presented at the APIC 2022 Annual Conference. Indianapolis; June 2022.
- Sivek A, Davis J. Ergonomics and duodenoscope reprocessing: Is there a problem? Session 3003. Presented at the APIC 2022 Annual Conference. Indianapolis; June 2022.
- Food and Drug Administration. Use duodenoscopes with innovative designs to enhance safety: FDA safety communication. Updated June 30, 2022. https://www.fda.gov/medical-devices/safety-communications/use-duodenoscopes-innovative-designs-enhance-safety-fda-safety-communication
