Cleaning and reprocessing reusable sterile equipment create droplets and sprays of water that soak healthcare workers and travel as far as seven feet into the decontamination room, researchers reported.1
While researchers used clean equipment, normally “sterile processing personnel decontaminate medical devices that are heavily soiled with blood, tissue, and secretions,” the authors noted. “Contamination may spread throughout processing areas, potentially exposing personnel and patient-ready devices, especially when there is insufficient separation between the dirty and clean areas.”
Sterile processing workers participating in the experiment wore the full regalia of personal protective equipment (PPE), but there is concern they could contaminate themselves during doffing and potentially touch a mucous membrane, such as the eyes or nose. Researchers also found a common breach in PPE.
“When they use a spray arm to spray off instruments, that generates splash,” said Cori Ofstead, MSPH, president and CEO of Ofstead & Associates, a healthcare research and consulting firm in Bloomington, MN, during the 2023 Association for Professionals in Infection Control & Epidemiology (APIC) conference. “We rinsed out a stainless-steel basin, which would be grossly contaminated, but [for the study] it was sterilized. We [saw] droplets four feet away on a cart, six feet away on the wall, and on the floor — 7.2 feet away from the sink.”
Ofstead underlined the fact she and her colleagues performed each activity once. “In a normal session, they’re not going to clean one probe or one scope or one stainless steel instrument — they’re going to do a few, or dozens, or hundreds of them,” Ofstead said.
The distance is significant, as the consensus on the droplet range of contaminated water while cleaning medical instruments has been about three feet or no longer than one meter.
Ofstead and colleague Krystina Hopkins, MPH, a research manager at Ofstead & Associates, have authored two papers on their research, and some of those findings were the basis of their most recent work. “The origin of this three-foot separation recommendation was an outbreak investigation involving multidrug-resistant Pseudomonas aeruginosa that infected 36 patients in Canada,” Hopkins reported with Ofstead at APIC 2023. “[Overall,] 12 deaths [were] attributed to the infection. Investigators found contaminated sink drains in intensive care rooms. Although this investigation did not involve instrument reprocessing areas, the findings have been used to support the recommendation that three feet of separation between dirty, wet areas and clean, dry areas is sufficient.”2
But according to these new findings, that does not seem to be the case. The manual cleaning process used for contaminated instruments involves immersing them in water with detergent and scrubbing, brushing, and spraying to remove residual blood and tissue. The PPE worn typically includes gowns, gloves, face masks, eye protection, head coverings, and shoe covers.
To identify droplets and splashes, the researchers used water detection sheets — a blue paper that turned white when wet. These were attached to the workers and placed in different areas of the decontamination room.
Droplet Exposure to Neck Area
The experiment revealed a chink in the PPE armor, as droplets landed in the exposed neck area beneath the face shield. As the workers leaned over the sink while cleaning equipment, droplets and splatter contaminated their necks and lower face.
“I’m concerned about this because most of the sterile processing techs we encounter are not wearing a mask with any fluid resistance,” Ofstead said. “They don’t change those masks very often.”
Workers tried a face shield with an expandable neck cover during the experiment, but it was not practical for those who wore glasses (i.e., fogging and discomfort). Most cleaning activities caused dispersion of droplets, beginning with filling sinks with faucets that are placed directly over drains.
Because of this finding, one sterile supply manager working with the researchers changed her policy to require workers to stand three to four feet back from the sinks while they are filled.
“That is using an administrative control that reduces their exposures,” Hopkins said. “When we’re talking about administrative controls, one of the things at the top of the list is audits and risk assessments.”
Identify areas where there is a risk of droplet or splash exposures, adopting policies as needed to prevent exposures to healthcare workers. “Then, you need to go back and make sure that they’re doing it properly,” Hopkins added. “You need to make sure that they’re wearing their PPE correctly and following any policies you established to minimize their exposure.”
While most instruments can be cleaned under water, some equipment like ultrasound probes must be cleaned without submersion. “Some [manufacturer] instructions for use say you’re supposed to do the cleaning by holding the probe under running water, up out of the [sink] water, brushing it with a bristle brush,” Ofstead explained. “This led to a lot of droplet spray and contamination of the workers’ PPE.”
Because of the surprising range of the droplets in general, researchers said visitors and colleagues should not enter the decontamination area without donning full PPE. “We have to be thinking that anybody entering that premises is at risk and should be in full garb all the time,” Ofstead said.
Doffing PPE
That raises the issue of correctly and carefully removing PPE, which became apparent as a common source of worker exposure during the Ebola outbreak in 2014. “We’ve shown that they get grossly contaminated with droplets,” Hopkins noted. “We need to tell them how to get that PPE off without contaminating themselves. That [involves] training and competency testing. Maybe we need to think of expanding hand hygiene to other areas that PPE is not covering.”
Noting ill-fitting and wrong-size PPE heightens the risk for exposures, Hopkins suggested “fit testing” gowns and gloves for new hires. “Even if we can’t reduce splash immediately, we can start building into our onboarding practices not only understanding of policies, but PPE fit testing,” she said.
In addition, there are devices like Plexiglass covers for sinks with holes where the hands enter. “Bring on the Plexiglass,” Hopkins said. “We want to see barriers that protect workers. And we need better PPE ... that’s more comfortable to wear, and that’s available in sizes that fit an increasingly diverse workforce. We can’t just use disposable instruments for every single thing that we need to do. What that means is that we have to have a worker at the sink.”
ECRI Testing Gowns
At another session at APIC 2023, ECRI updated its ongoing research into tears, strikethroughs, and leaks in medical gowns.
“In the past few years, we’ve noticed through ECRI’s problem reporting system, from our member hospitals, that we are still seeing a lot of [gown] leakage, tearing, contamination,” said Karen Haberland, MS, senior project officer at ECRI. “We know that this problem hasn’t gone away, and we really want to work on improving PPE.”
Recently, ASTM International published medical gown standards that include additional labeling requirements that help identify the properties of the PPE.3 “Fluid [protection] and physical properties like tensile strength, tears, and seams are really important,” Haberland said. “They’re the difference between getting a trash bag, which a lot of you may have had to wear in the pandemic. They’re great for fluid barrier protection. But they also don’t breathe, and they will snag on everything in a hospital room.”
As designated by the FDA, medical gowns are either Class I or Class II. “Class II gowns are sterile and primarily going to be used in surgery,” Haberland said. “Pretty much every other gown is a Class I. Unfortunately, that means that they don’t have to provide any data to the FDA. I highly suggest if you are reaching out for gown quotes, ask the manufacturer if you can see their testing data. There is no requirement that fluid barrier testing [be performed in] a certified testing lab, so make sure that it’s a lab that you trust or do your own testing.”
In inspecting gown labels from different manufacturers, Haberland found “all labeling is not created equal, and often does not contain all the required information.”
In particular, the lot number is critical in case there is a common problem, and the gowns have to be pulled from supply. “You also really want [label] identification to tell your user how protective this is going to be before they put it on,” Haberland noted. “That’s things like identifying if it was an isolation gown or a surgical gown, identifying the [FDA] class level, and identifying the size. The size is really critical to make sure that you have the proper coverage.”
For example, a gown that is too small tends to ride up on the arms, exposing the wrists. But simply buying large gowns creates other problems.
“We have a tendency to buy the universal or the extra-large and say this will cover everybody,” Haberland said. “Unfortunately, that leads to gaping at the neck, or bunching. I highly suggest that you look into stocking a larger range [of sizes] to make sure that they fit properly on everyone.”
Some manufacturers of reusable, washable gowns include an expiration date on the label. “That’s really important because people don’t realize that there are coatings on some of these,” Haberland explained. “You’d think these are plastic gowns; they should last forever. But if they have that coating, it might start flaking off. They will actually start to degrade fairly soon, so make sure you rotate your stock out.”
Disposable Gown Tears
After receiving a lot of questions and comments, ECRI is conducting ongoing research on a common Class I gown called “disposable, non-woven, level two isolation gowns.” Gowns of this type from a variety of manufacturers are put through a series of comparative tests. “We brought in experienced users, people who use isolation gowns on a daily basis,” Haberland said. “They wore the gowns for a period of time, and we put them through some different activities. Then, we had them rank each of the gowns against each other.”
ECRI is using fluid barrier testing technology that includes hydrostatic pressure testing — a column of pressurized water to see if any drops come through the gown material. “This testing was all performed with water,” Haberland noted. “Bodily fluids have a lower surface tension than water and they’re usually warmer, which could make them more likely to strike through than water.”
The gown tests are ongoing, but Haberland identified failure at the gown seams as one problem. “If you have [a gown with] sewn seams, you really want to make sure that they’re covered in a film or a tape to eliminate the possibility of them failing,” she said.
Some of these disposable gowns are designed to be simply torn off after use, but tearing beyond the designated areas occurred frequently. “Unfortunately, every gown had at least a couple of issues with tearing during removal,” Haberland said. “Instead of breaking at their designated ties or perforations, where they’re supposed to, they would rip down the front. We had users who got stuck in their gowns. The front half of the arm would rip off and they’d still have half the gown on. That would be really bad for contamination of our scrubs. We need to work with manufacturers to improve this issue, but we also need to make sure that we’re training our staff to doff properly to make sure these things don’t happen.”
REFERENCES
1. Ofstead L, Hopkins KM, Daniels FE, et al. Splash generation and droplet dispersal in a well-designed, centralized high-level disinfection unit. Am J Infect Control 2022; Sep 15: S0196-6553(22)00629-0. doi: 10.1016/j.ajic.2022.08.016. [Online ahead of print].
2. Ofstead L, Hopkins KM, Smart AG, Brewer MK. Droplet dispersal in decontamination areas of instrument reprocessing suites. Am J Infect Control 2022;50:126-132.
3. ASTM International. Standard specification for isolation gowns intended for use in healthcare facilities. Feb. 6, 2023.
Cleaning and reprocessing reusable sterile equipment create droplets and sprays of water that soak healthcare workers and travel as far as seven feet into the decontamination room, researchers reported recently.
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