By Kelly M. Pyrek

This article originally appeared in the April 2022 issue of Healthcare Hygiene magazine.

Confirming that sterile processing department (SPD) personnel are routinely doused with potentially infectious material during routine decontamination tasks, a team of researchers is drawing attention to the lack of research around this occupational exposure, highlighting the fallacy of the 3-foot droplet dispersal standard, and pushing for better personal protective equipment (PPE) in this barrier protection-depleted time due to COVID-driven shortages.

Researchers Cori Ofstead, president and CEO of Ofstead & Associates, and her colleagues conducted a pilot project to identify reprocessing activities that generate splashes, determine how far droplets can travel in decontamination areas, and assess PPE exposure during routine activities. The team says that the effectiveness of protective measures for sterile reprocessing personnel has not yet been systematically evaluated in real-world settings and were surprised and dismayed by the lack of evidence on this topic despite the known risks around decontamination and reprocessing activities in the SPD.

Also, there are no data around occupational exposures of sterile processing personnel in EPINet data from the International Safety Center, which serves as a clearinghouse for metrics relating to sharps injuries and bloodborne pathogen exposures. However, any observer in the SPD knows that splashes occur daily.
The lack of peer-reviewed evidence in the literature served as a major impetus for Oftstead’s latest study.

Ofstead says she has long championed under-researched challenges in the SPD, which she says is partly due to the admiration she has for these professionals.

“The critical role of sterile processing has been under recognized and undervalued in many organizations,” Ofstead says, “Even though in my view, the SPD provides the foundation for safety In healthcare institutions and the success of every surgery or medical procedure depends on the work they do. However, they're often tucked away in the basement of the facility and people don't think about them. We've learned that there's a widespread lack of real-world research on how things work in sterile processing, including the instructions for use (IFUs) -- can they be read and understood? Are they able to be implemented by a human? And if so, do the IFUs work?”

Ofstead continues, “Our research is intended to prompt people to rethink strategies and protocols for effective sterile processing that will get the instruments where they need to be, but also are humanly possible and not going to break the human in the process. I got upset because we heard from the grounded, hard-working people in the field about the extent of the shortages of PPE and other critical supplies like disinfecting wipes and hand hygiene supplies. Shortages were hitting SPDs hard because supplies were being diverted to other units that were thought to be at the highest risk. But what happened is that SPDs didn't have adequate supply of some PPE at all, or they received Ill-fitting, poor-quality gowns that weren't fluid-resistant, and gloves that don't fit, and no disinfecting wipes for the SPD.”

As Ofstead, et al. (2022) explain in their study, “Personnel working in sterile processing or endoscope reprocessing departments are also at high risk of exposure to tissue, blood, and patient fluids during the decontamination of reusable medical instruments and equipment. Manual cleaning generally involves immersing instruments in water with detergent and scrubbing, brushing, flushing, suctioning, and using power-spraying systems to remove blood, tissue, and patient secretions.”
“It's not a theoretical risk that they might get exposed to droplets like it is in the ER, for example,” Ofstead says. “In the SPD they are doused from head to toe with hazardous solutions and potentially infectious material all day, every day. [SPD personnel] told us they were given one mask a day, and they were supposed to re-don it. They are taking splashes to the face all day, so they need new masks. When it comes to dispersing PPE, the SPD must be prioritized because it is not a theoretical risk of a low-probability splash happening, it is something real they face every day. At the time of the study, people also told us they also were expected to reprocess single-use gowns.”

Ofstead says that reusing gowns might be more acceptable at the reception desk or in the admissions department, but not in the SPD. She also says she bristles over the issue of barriers that are erected for the sake of appearances only.

“I think that in many healthcare facilities and in all kinds of institutions, there's a lot of safety theater,” Ofstead says. “For example, if you think about the reception area in a doctor's office or the admission office, almost all of them have installed plexiglass barriers. Sometimes whoever installed them really meant it because it goes from the counter all the way to the ceiling and barely has a little slot where you can pass paperwork back and forth. Every institution I visited in the last year and a half or two years have these extensive plexiglass barriers in the reception areas and admissions departments, and yet they do not have them in sterile processing. There is a theoretical risk that a patient might come in and cough at the reception area, but so far, in places I've gone to, all patients and families have to wear masks when they approach; so, you have masked persons – including staff -- and presumed source control in place, so the theoretical risk is greatly reduced, especially when presumably there is a counter or a desk that provides at least 2, 3 or 4 feet of physical distance. Facilities provide engineering controls to protect people where there's probably not even really a risk. And then you go to sterile processing, where they're plunging their arms into sinks full of hazardous materials and they're going to take splashes to their face and neck of hazardous and potentially infectious material, and yet there are little to no engineering controls at all. That, to me, is a serious problem.”

Ofstead says she witnesses examples of inappropriate safety theater in other areas of the hospital as well. “I continue to see healthcare workers who don gloves to do paperwork or to take someone’s pulse or blood pressure. With those kinds of tasks, you’re probably not going to get that much infectious material, and the alcohol gel would take care of it. So, we don't have ample supplies of properly sized, effective gloves in the decontamination area in the SPD, but you're going to take somebody's blood pressure with gloves on. This is not right. So, our goal with raising this issue is to start shining light on where the real risk is. And not perform the safety theater around these mostly theoretical, extremely low-risk situations.”

In their study conducted in the SPD of a large urban hospital, the researchers taped moisture-detection paper to environmental surfaces such as counters and floors adjacent to sinks, as well as affixing the paper to articles of PPE, including face shields, masks, gowns, gloves, and shoe covers. To assess droplet dispersal, the researchers asked SPD personnel to perform several routine cleaning tasks in a work area that was thoroughly cleaned, terminally disinfected, and dried using non-linting wipes before initiating pilot activities. These tasks included filling an empty sink; gently placing instruments into water, brushing lumens of scopes, using a power sprayer to rinse a stainless-steel basin, and using a sonication system. The researchers documented the droplet generation through photography, videography, and observation by researchers, who noted any visible droplets, recorded the distance of visible droplet dispersal, and documented PPE exposure to droplets.

The researchers found that visible droplets were generated during every reprocessing activity except running the sonication sink. Droplets traveled at least 3 feet when filling a sink, brushing scopes and using a power sprayer. Some reprocessing activities dispersed droplets up to 5 feet from the sink, the researchers found, and most notable was that PPE was splashed during most reprocessing activities and did not prevent skin exposure, despite being worn properly.

Ofstead and her team emphasize in their study that while their findings are eye-opening, there is precedence, and the potential for exposure to splashes and airborne droplets has long been recognized, going all the way back to the mid-1970s and a case report describing an endoscopist who was exposed to herpes-laced patient fluids that splashed out of the biopsy port of a gastroscope and into the provider's eye, triggering a systemic herpes infection (Kaye, 1974). Fast-forward to 2019, where a study by Johnston, et al. found that almost half of face shields worn by endoscopists were contaminated during gastrointestinal procedures, and droplets were found on 21 percent of face shields affixed to procedure room walls approximately 6 feet away.

The researchers note further that “standards and guidelines recommend several practices to minimize reprocessing personnel exposure to splashes, such as brushing and scrubbing instruments while they remain under the surface of the cleaning solution and the use of PPE including shoe covers, gowns, gloves, face masks, eye protection, and head coverings. In addition, guidelines recommend physical enclosure of decontamination areas and specify a minimum of 3 feet of separation between decontamination areas and clean work areas to prevent cross-contamination.”

“Everybody says droplets go 3 feet,” Ofstead says. “There are many SPDs that have those red stripes, and you know the droplets stop right there on the red stripe,” she adds, tongue planted firmly in cheek. “There's no evidence around that, and the only citation we found that backed up AORN guidelines is an outbreak in the ICU, where a sink had the pathogen in the drain and they found that with fluorescence, they could document that when you turn the faucet on, the drops from the drain area were kicking out at least 3 feet. They didn’t say droplets stop at 3 feet, just that they could detect them out to 3 feet, and we think they went further. So, I am dismayed that there's no peer-reviewed research, no evidence, and yet we have built our protocols based on this idea that droplets only go 3 feet.”

Ofstead says the 3-foot distance originated in an outbreak investigation involving multidrug-resistant Pseudomonas aeruginosa that infected 36 patients in Canada due to contaminated sink drains in intensive care rooms. The investigators discovered that droplets traveled at least 1 meter away from sinks and hypothesized that smaller particles may have traveled farther but were too small to be observed. While this report was not conducted in the SPD, Ofstead says the findings have been used to support the recommendation that 3 feet of separation between dirty, wet areas and clean, dry areas is sufficient.

In their study, Ofstead, et al. (2022) observed visible droplets up to 5 feet away on vertical surfaces and the floor as well as on the face shield, gown, shoe covers, and on blue paper affixed to the chin and neck area below the face shield. Of importance is the conformation that PPE did not provide adequate barriers against skin exposure, as the researchers documented that extended-cuff gloves were not long enough, exam gloves did not fit snugly enough, and moisture was allowed to penetrate the PPE

Ofstead acknowledges that several factors come into play when SPD personnel are exposed.

“I've conducted many audits in facilities where people weren't wearing PPE or they weren't wearing it correctly,” she says. “And I would have laid most of the responsibility for PPE not working on the lack of adherence by staff. In this study, though, they suited up from head to toe. They used the tall shoe-cover boots that go to the knee, but they did not prevent droplets from hitting them. They told me it was happening, but you must see it for yourself. The skin exposure happened within seconds of every activity. It wasn't like they're working in there and after two hours, they eventually get a little bit of material on them. In this study, we could only detect big droplets. Either we would see the spray and document it on video or we could see it on the blue paper. We couldn’t detect airborne transmission, but we know it’s happening, and it's disturbing.”

Particularly in light of the pandemic, which raised awareness of risks associated with aerosol-generating procedures. As we know, the Centers for Disease Control and Prevention (CDC) recommended administrative and engineering controls and the use of PPE as risk mitigation strategies. The guidance included wearing respiratory and eye protection by personnel who could be exposed to aerosols, as well as fluid-resistant surgical N95 respirators worn by workers needing protection from both fluid and airborne hazards. As Ofstead, et al. (2022) note, “Although sterile processing and endoscopy personnel are at high risk for exposure to fluids and aerosols, they generally wear a regular face mask and a drop-down face shield or a face mask with a pop-up face shield (not N95 respirators).”

That said, there are challenges associated with wearing a full suit of PPE, and research has indicated that discomfort is one of the reasons why healthcare personnel do not wear certain articles of PPE properly.

“We need better PPE products and I think a redesign is advisable,” Ofstead advocates. “We need face shields that don’t steam up and improved neck protection. When I'm wearing a full set of PPE and we're doing sample-collection tasks for our research, I must choose between wearing glasses and wearing a face shield because if I wear a face mask, face shield and glasses, the glasses and the face shield steam up. We need a system similar to what is used during orthopedic implant surgeries where you're going to protect the whole head space with tolerable equipment that workers can stand to wear and that can let them function in the way they need to. They must be able to see, obviously. So, that should be redesigned. It’s hot in the SPD when you're working with warm or hot water and you're doing vigorous physical activity. When you're suited up like that, it's very uncomfortable. As I think about it, this leads me to believe we’re off target by thinking that this is only a PPE issue.”
Ofstead continues. “This issue takes me back to my lab days where when we worked with a potentially hazardous substance or anything that could be infectious, we performed the task in a hood that was negative pressure; if there was any hazardous material present, it was sucked out. And for any little splashes, we would wear goggles. We mostly did not wear masks because the hood protected us from exposure. A hood gives you physical protection, and it’s a control that doesn’t rely on the individual to don PPE correctly.”

“How much more comfortable would it be in the decontamination area If you didn't have to worry about being exposed,” Ofstead adds. “Part of it is when you know you're going to get splashed, you hold your head at an angle, or you tip your head in order to have the splashes land on the face shield and not up under your neck and so, I think the solution we need is re-engineering, re-design.”

Ofstead points to how washer-disinfectors are a good example of automation helping to remove the human factors that can result in errors or adverse events. “It keeps people from being exposed. In the long run, I think automation is a desirable thing. If we can automate something or have a machine do part of it, but if we're going to have humans do it, we should be thinking about PPE as the last line of defense, not the first and only line of defense.”
The need for barrier protection is clear. As Ofstead, et al. (2022) explain from their study, “Despite wearing a mask and a drop-down face shield, droplets were observed on paper affixed to the mask and chin and neck areas. This is concerning because fluid-resistant masks are not required, and personnel are not currently urged to wash their faces and necks after doffing contaminated PPE. Multiple droplets were detected on foot and shin areas, which suggests that tall boot covers are essential for personnel working in decontamination areas. The fronts and arms of gowns were saturated with water within a few seconds of initiating manual cleaning, highlighting the importance of liquid-impermeable gowns.”

“The improper donning and wearing is what we had seen in facilities, but I've never audited any institution, any department where I consistently thought people were wearing the right PPE correctly,” Ofstead says. “With COVID now, we have a new recognition of droplet transmission along with continuing to be worried about infections caused by superbugs. I'm worried about the doffing and the reuse of PPE. I often go into units and see hooks in the break room or in the locker room, or in SPD, and there are gowns on them. You can see colorful droplets on them. SPD personnel tell me they put these gowns back on after their break. I don't know if you can don a contaminated piece of PPE without exposing oneself, but I think that's a very high risk. Reusing PPE and hanging dirty gowns on hooks so they can be re-donned by personnel should never happen. I see no circumstance where that would be ever appropriate.”

The study illuminated risks associated with circumstances that frequently occur in SPDs but also bring new attention to the often-ignored issue of ergonomics and body mechanics involved during processing tasks.

It’s an issue also noted by patient safety organization ECRI in its 2022 list of Top 10 Health Technology Hazards. A 2021 ECRI survey of healthcare workers who routinely perform duodenoscope reprocessing identified several significant patient and worker safety hazards including obstacles to effective reprocessing. Survey respondents cited time pressures and poor work environment ergonomics (e.g., work surfaces at an uncomfortable height) as key concerns. ECRI specifically called out a higher risk of healthcare worker musculoskeletal injuries due to poor workspace ergonomics.

As Ofstead, et al. (2022) observe, “Non-adjustable sinks cause significant discomfort for technicians of different heights and preclude them from leaning far enough into the sink to perform manual cleaning with instruments fully immersed in cleaning solution.”
The instructions for use (IFUs) are of little help in this issue, according to Ofstead who remarks, “They don't generally address workers’ safety, and they don't want to talk about minimizing splashes or droplets in ways that are particular and actionable; generally, they don't mention this issue at all. And so, there are guidelines and standards that would say, ‘brush instruments underneath the surface of the water whenever possible,’ and that's absolutely a good idea, but it introduces other issues -- if you lean over enough to fully immerse the instrument, you're going to have ergonomics-related issues, as that’s an awkward task to perform if not at the right height.”

She continues, “When you're going to cover-brush instruments fully immersed, your hands and your arms are in the water. And when you're in decontamination, you're going to assume that that instrument is covered with patient tissue, blood, and other potentially infectious material, so the water must be assumed to be very highly contaminated. So now we're going to plunge our hands into this water and we're going to assume that the barrier protection of the gloves is going to provide ample protection for that, and it's not true. Even with gloves with extended cuffs, it turns out that they're not tall enough, and they fall down with vigorous physical activity. So, when you are brushing, scrubbing, rinsing, raising and lowering your hands and arms, the gloves fall down. Which is a result of not testing them in the real-world activity for which they are being used. We must return to considering carefully how PPE is used and ensure it’s offering the level of protection needed for the task.”
Ultimately, the researchers raise the question of how far droplets travel and whether they contain soil, bioburden, or viral pathogens, and note this is largely unknown.

“Because of COVID, we've now come to recognize again the phenomenon of droplets falling and going everywhere,” Ofstead says. “What happened is that we began to accept things like reusing single-use PPE. That's scary. So, COVID set the bar lower for infection control overall. And it almost institutionalized, or gave permission for not doing the right thing, I don't know how we’re going to shift away from that. Institutions will continue to think, ‘If personnel can wear that gown or that N95 again,’ that gives them permission to continue cutting corners and think they got away with it. Even though we are starting to see a huge uptick in preventable healthcare-acquired infections like CLABSI, cutting corners is now accepted somehow. To me, that means we need to turn this around before we build a belief system in which this is okay to do. It’s not.”

The researchers suggest steps akin to the CDC’s hierarchy of controls for mitigating potential cross-contamination and protecting sterile processing personnel, such as training staff on recommended practices for reducing splash, maintaining a dirty-to-clean workflow, cleaning and disinfecting workspaces between reprocessing activities, as well as donning and doffing PPE correctly. But they emphasize, “Environmental controls are clearly needed to reduce the risk. Possible solutions could be the use of hood-like systems with negative pressure ventilation and plexiglass barriers to physically prevent exposure to splashes; new designs for sinks, faucets, and power sprayers; and automated systems that perform some of the higher-risk activities.”

Ofstead acknowledges the significance of the challenges ahead. “I know infection preventionists are understaffed and overwhelmed and they're going to struggle to take leadership on this issue. And SPD leaders haven't been able to get the resources they need, so I'm not sure where it will come from, but maybe we make some noise. We're working on what we're calling ‘Splash 2.0,’ another study right now and I'm hoping that we'll write a follow-up paper this spring. What needs to happen is that other researchers and other organizations also conduct research on this problem, because a small handful of studies doesn't provide evidence that's wide enough to write and issue a big guideline. Guideline-issuing bodies can't responsibly make new recommendations unless they have a significant body of evidence on which to base their guidance. I think it is on members of industry and on those of us who are in a good position to do research, to document this problem. I also think it's on industry to conduct research on the effectiveness of PPE; in the meanwhile, if we can document this problem enough, I am confident we will no longer say droplets only go 3 feet.”

References:
Association for the Advancement of Medical Instrumentation (AAMI), American National Standards Institute (ANSI) ANSI/AAMI ST91: Flexible and semi-rigid endoscope processing in health care facilities. AAMI, Arlington, Va. (2015), Pp. 1-70.
ECRI. Top 10 Health Technology Hazards for 2022.
Johnston ER, Habib-Bein N, Dueker JM, et al. Risk of bacterial exposure to the endoscopist's face during endoscopy. Gastrointest Endosc, 89 (2019), Pp. 818-824.
Kaye MD. Herpetic conjunctivitis as an unusual occupational hazard (endoscopists' eye). Gastrointest Endosc, 21 (1974), Pp. 69-70.
Ofstead CL, Hopkins KM, Smart AG, Brewer MK. Droplet dispersal in decontamination areas of instrument reprocessing suites. Am J Infect Control. Vol. 50, No. 2. Pages 126-132. February 2022. https://doi.org/10.1016/j.ajic.2021.10.023
Van Wicklin SA, Conner R, Spry C. Guideline for processing flexible endoscopes. Guidelines for Perioperative Practice, Association of periOperative Registered Nurses (AORN), Denver, Co. (2017).