Scratching below the surface: How taking a closer look at your sterilization packaging systems can increase patient safety

The sterile processing department used to be a little-known department in the hospital, relegated to the basement or tucked away in a not-oft-visited area of the hospital and ignored by quality improvement initiatives and accreditation organizations, according to Peg Luebbert, an infection preventionist with Nebraska Orthopaedic Hospital.


"[Leadership] always felt there were bigger fish to fry somewhere else" in terms of infection control and prevention, says Ms. Luebbert, who also serves as the owner and a consultant at Healthcare Interventions, Inc., and is also paid by Halyard Health.

However, that attitude is changing fast, in large part due to the endoscope-related bacterial outbreaks that plagued hospitals across the U.S. starting about five years ago. "When the outbreaks started … we recognized that we can decrease infections related to instrumentation, [and] the sterile processing department was brought to the forefront," Ms. Luebbert says.

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Since then, hospitals and surgery centers have been hyper-focused on properly reprocessing the difficult-to-clean reusable scopes, and for good reason. But the sterile processing department's role in preventing surgical site infections and healthcare-associated infections goes beyond sterilizing and reprocessing endoscopes and other instruments. This department is also responsible for assembling, packaging, sterilizing and storing sterile surgical trays between uses in the OR and other hospital departments.

"I think one thing that people tend not to realize with SPD is how many dozens of steps are in the process — bringing dirty equipment from the OR, cleaning it and bringing it, clean, back to the OR," Ms. Luebbert says.

Following best practices when sterilizing and reprocessing surgical tools is integral to patient and provider safety. Just as important is having a sterile packaging system in place to maintain sterility effectively up until the point of instrument use. However, recent studies of different sterile packaging methods found that not all packaging systems are created equal, and organizations using rigid containers may unintentionally put their organizations at risk.

For this reason, infection control leaders see an opportunity to substantially improve patient safety by reexamining and updating their sterile packaging systems.  

The importance of sterile packaging systems

Sterile packaging systems — i.e. wraps or rigid containers that protect sterile surgical trays — were put in the crosshairs in a December 2015 study published in the American Journal of Infection Control. For the study, researchers used aerosolized bacteria to test 111 rigid containers of varying ages and 161 wrapped trays with three grades of bonded sterilization wrap for bacterial ingress.

None of the wrapped trays demonstrated bacterial ingress into the tray after the test, according to the study, while 97 of the 111 rigid containers (87 percent) showed bacterial ingress. Additionally, the study found a positive correlation between contamination rates of a rigid container and the container's age.

"The study … brought to our attention, surprisingly, that there are concerns with some of our rigid containers being able to maintain that sterility," Ms. Luebbert says. "Most SPD people, as well as infection preventionists, were very surprised by the conclusions of that study."

One reason the findings were surprising is because rigid containers have been used in hospitals for years, and experts assumed they were maintaining sterility. "They looked tough and strong and were able to be moved easily," Ms. Luebbert says. "We thought we didn't have to be concerned with rigid containers."

Consensus statement

The study in the American Journal of Infection Control spurred infection prevention advocates from multiple areas of the industry — including Ms. Luebbert — to come together and pen a "Consensus Statement on Sterility Maintenance of Sterile Packaging Systems in the Hospital Setting." Halyard Health published the statement in July 2016.

"When the study came out, we recognized that these were new and unexpected results for our SPD world," Ms. Luebbert explains. "We needed to put together a consensus statement [with clear calls-to-action] to help users in the field get some direction, [because] once they saw these results, their response was going to be, 'Oh my, now what do I do?'"

The group developed the following three recommendations:

Enforce proper maintenance and handling of sterile packaging systems. Because the study showed rigid containers can put instruments at risk for bacterial contamination, it is critically important for sterile processing departments and central supply professionals to do two things: Follow manufacturers' instructions for use and undergo training on how to test the trays to identify defects, according to the statement.

Sterile processing departments and central supply professionals should test rigid containers to ensure they are safe, especially if the containers are older and have been in use for a long period of time. Initial efficacy tests are fairly simple, according to Ms. Luebbert. One involves placing a dollar bill over the edge of the container and sealing the tray. If the dollar bill can move, the seal is not sufficient. "SPD staff love that one, it's fun to do and effectively indicates a potential risk," she says.

Another test involves placing liquid in the tray, sealing it and tipping the container. If the fluid is maintained, the container has an effective seal; if it drips out, it failed the test.

Foster cross-department collaboration. "Communication is often limited between SPDs and infection preventionists, and … the vast majority of infection preventionists do not incorporate SPS [sterile packaging systems] into their risk assessments," according to the consensus statement. "This study demonstrates the importance of collaboration between SPDs and infection preventionists in improving patient safety and reducing risk for SSIs."

Ms. Luebbert says, "We're wasting our time in trying to prevent infections if SPD is not involved. It starts there with clean, sterile instrumentation. When it enters the suite it needs to still be sterile."

In other words, teamwork is necessary to keep containers sterile and patients safe, and hospital leaders need to foster collaboration among the sterile processing department, infection preventionists, quality department leadership, CNOs and nurses, and surgeons regarding best practices for maintaining and handling sterile packaging systems.

To do so, leaders can add a representative from the sterile processing department to quality committees that address infection prevention policies and concerns. "Bringing them to the committee meetings helps the rest of the hospital understand the intricacy of their department and how important it is," Ms. Luebbert says. "The overall goal is that they are recognized as part of the healthcare team."

Additionally, operating room staff should be trained on proper handling of sterile packaging systems and how to identify problems with surgical tool storage. They can act as a powerful second line of defense against dirty surgical instruments.

Advocate for increasing the rigor of sterile packaging systems protocols and guidelines. The consensus statement authors recommended bodies like the Food and Drug Administration, the Association for the Advancement of Medical Instrumentation and the Joint Commission to "strongly consider requiring dynamic aerosol tests to be performed on all SPS on two separate occasions between the time of sterilization until use in the OR." They included that recommendation because the study in the American Journal of Infection Control showed "achieving sterility at the time of sterilization is not a predictor of continued sterility after transport and handling, until use in the OR."

Additional step

Along with the aforementioned recommendations from the consensus statement, hospital leaders can also require certification for sterile processing department workers — which is something that not all states require. Ms. Luebbert maintains that hospital officials should voluntarily make it a requirement. "It's important for administration to motivate staff to become certified," she says. She recommends adding as part of the job description that the employee will become certified within a certain time period of being hired, and then supporting them throughout the process. Hospitals can also provide some perks — like a pay bump or an adjusted title — in recognition of certification.

Hospitals should also take the December 2015 American Journal of Infection Control study into consideration when making purchasing decisions, as sterilization wrap was found to be more successful in maintaining sterility of surgical instruments.

All of these steps and considerations help hospitals work toward one goal, according to Ms. Luebbert. "It comes down to keeping clean, clean, no matter where you're at or what you're doing," she says. "If you can keep clean, clean, your job is done."

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