With each passing day, we see new reports on the growing dangers of drug-resistant organisms and infection control breakdowns in the healthcare space. At times it seems as if this infectious world of pathogenic microbes is working around the clock to get faster and smarter at putting patients and their caregivers at risk. These tiny bugs have declared war on us, and are using every weapon in their microscopic arsenal to take us out.
Fortunately for our patients and the future of our industry, healthcare providers do not know the meaning of the word "surrender." In fact, there have been a number of game-changing innovations that are poised to defeat these infectious invaders on the very front lines of surgical care. We reached out to 5 healthcare leaders from across the country and across the spectrum of surgical care to highlight the kinds of innovations they believe are making a real difference in the infection control space.
1. Guidance documents
Wouldn't it be nice, Natasha Reese, MT (ASCP) CM, used to wonder, to have a definitive guide to best practices in infection prevention? Wonder no more. The Joint Commission's recently released "High-Level Disinfection and Sterilization Booster Pack" is Ms. Reese's bible of reprocessing. The 49-page publication links standards, evidence of performance and responsibility in one easy-to-follow script. The Booster Pack incorporates easy-to-use checklists and guidelines that speak the language of sterile processing technicians, operating room staff and infection preventionists. It also carries considerable weight when there's a difference of opinion in how a soiled instrument, for example, should be transported to sterile processing.
"I am the informer, not the enforcer," says Ms. Reese, the infection preventionist at St. Joseph's Hospital in Lexington, Ky.
Ms. Reese takes her bible with her when she does her monthly rounds for on-site surveillance, checking that instruments are processed at bedside before they exit the threshold of the procedure room and auditing case carts to make sure all instruments are opened and unhinged.
With recent focus shifting to bedside practice regarding instrument processing and handling of soiled instruments, investigations of contaminated instruments are being expanded beyond the limited focus of sterile processing, says Ms. Reese. Tools such as the Booster Pack that highlight the immediate point-of-use cleaning necessary to ensure sterilization or high-level disinfection of instruments are a critical part of preventing breakdowns in the life cycle of surgical instrument reprocessing. For infection preventionists, this means greater confidence as they observe OR staff handling instruments and ensure each step in the cleaning process is followed appropriately, says Ms. Reese.
These types of checklists also safeguard that instrument reprocessing is done as efficiently as possible by the SPD team. Ms. Reese notes that OR staff members are able to review the Booster Pack quickly to see what practice changes are pivotal in streamlining compliance with both Joint Commission standards and best practice.
The Booster Pack outlines specific steps required at the bedside, before the instruments leave the procedure area, says Ms. Reese. That's an important aspect of reducing the potential for retained bioburden and biofilm formation on surgical instruments. With easy-to-follow checklists, these steps can be implemented quickly to make certain the instruments are treated properly with each surgical procedure from removing bioburden and pretreating instruments, to ensuring that instruments remain moist while they are waiting in the OR. Importantly, says Ms. Reese, this document notes that it is the responsibility of the OR team to ensure bioburden does not dry on the instruments.
Another game-changing aspect of the Booster Pack is the further explanation of thresholds and transportation guidelines for soiled instruments. Ms. Reese explains that there had been confusion in the industry as to how instruments were to be transported from point of use to SPD, when they were to be pretreated and how they were to be carried. For some, the belief was that instruments could go from the bedside procedure to the soiled utility room to be pretreated. The Booster Pack clarifies that instruments are to be pretreated in the procedure room, before they cross the threshold. Only after this step can the instruments be transported from the point of use to SPD, and this must be done in an impervious container.
2. Storage concepts
One of the well-known infection control challenges in surgical instrument reprocessing is maintaining a sterile packaging barrier from the point of sterilization, into storage, through to the point of use. Deb Van Rooyen, operations supervisor for sterile processing and supply chain management at Hennepin Healthcare in Minneapolis, Minn., argues that innovative storage concepts addressing this challenge should top the list of infection control game-changers.
Ms. Van Rooyen notes that nearly all surgical facilities in the country use disposable surgical wrappers as a sterile barrier for the reprocessing of their surgical instruments. However, this particular packaging method has historically been prone to holes, rips and tears in the sterile blue barrier, causing a nearly ubiquitous infection control challenge, with very few holistic solutions.
When the integrity of surgical wraps are compromised by holes, the impact to the hospital and patient care can be substantial, says Ms. Van Rooyen, leading to a long list of things you'd rather avoid, such as delayed case start times (estimated $60 to $100 per OR minute), canceled cases, possible immediate-use sterilization of non-implant trays and potential patient exposure to dangerous pathogens.
Innovative storage concepts that streamline the sterile processing workflow, reduce unnecessary touchpoints and provide single-layer, touchless transport of surgical trays have reduced Ms. Van Rooyen's disposable wrap contamination to zero. After moving from traditional rack storage to a modular system that provides silicone-protected transport trays that carry surgical sets from assembly to the OR case cart, Ms. Van Rooyen says her organization has not experienced a single break in package integrity or case delayed due to wrapper contamination. With her process flow streamlined, she no longer has wrapped trays being stacked before sterilization, and now her staff can place wrapped trays directly on silicone-lined shelves on the autoclave rack.
This single-layer, transfer-rack storage innovation even improved Ms. Van Rooyen's case cart process, letting SPD technicians remove the entire transfer rack (shelf and all) out of the storage rack and place it directly into the case cart, without needing to touch the actual wrapped item. There is no lifting or pulling the trays, which is especially important when dealing with heavy trays, she explains. With this storage system, human hands don't touch the assembled surgical tray until it's opened for setup in the OR. The potential for damage to the sterile tray has been drastically reduced, says Ms. Van Rooyen, leading to more efficient processing and safer outcomes for patients. Sterile processing departments no longer have to store bulky metal instrument containers that take up extra space, are difficult to handle, and must be cleaned and meticulously maintained.
Rather than a source of potential contamination, game-changing sterile storage innovations that integrate single-layer storage and removable transfer racks can help facilities put an end to one of the biggest infection control challenges in surgical instrument storage.
3. Rapid read biological indicators
For many years now, the primary method to challenge the efficacy of low-temperature sterilization was to use biological indicators (BIs) with a 24-hour incubation period. As John Rowe, sterile processing manager at University Health System in San Antonio, Texas, explains, unless the items were properly quarantined, this was basically a 24-hour window where a scope or camera could be used multiple times, on multiple patients without knowing there was a sterilizer failure. ? Even though guidelines advised to quarantine medical devices until the BI incubation period had ended, few sterile processing departments had either sufficient inventory or commitment to abide by the 24-hour timeline for their low temperature-sterilized devices. Mr. Rowe notes that any positive biological finding would have resulted in a recall of instruments that were likely to have already been used on surgical patients.
Mr. Rowe believes this risk should be a top concern because numerous patients could face an infection outbreak with a minimally invasive surgical procedure that was actually designed to lessen the stress and strain of surgery. Instead of providing safe, sterile instrumentation for surgery, sterile processing departments who neglected the 24-hour incubation period could unknowingly be cross contaminating patients and causing life-threatening infections.
In light of this, Mr. Rowe's pick for a game-changing infection control innovation is the new technology that allows for rapid biological indicator results in 30 minutes or less, a reduction of more than 23 hours of uncertainty. He argues this gives greater confidence in the safety and security of a negative growth read out on a BI for laparoscopic instrumentation that needs to be turned over quickly for same-day procedures. Sterile processing technicians can now have documentable results with a much more narrow window for potential errors to occur. With a previous 24-hour BI failure, load recalls involved large quantities of sets, numerous physicians notified and ultimately multiple patients who could be put at risk.
As Mr. Rowe explains, with rapid-read BI results possible in under 30 minutes, ORs and sterile processing departments now can enact strict compliance with regard to equipment manufacturers' instructions for use, such as running biological indicators on an every load basis. Additionally, these quick results also reduce the number of technician hands in the process, says Mr. Rowe, eliminating the need for one technician to hand the process over to the next technician 2 shifts later. Advanced incubators that interface with instrument-tracking systems free technicians from manually entering the data into the system.
4. Instrument visualization
In the sterile processing service (SPS) department at Northeast Ohio VA Health Care System in Cleveland, Ohio, Assistant SPS Chief Shawn Huelsman believes technological advances in the realm of surgical instrument visualization should top the list of recent infection control innovations. As the third largest VA hospital in the country, his SPS team leads the nation in using new technological advances to improve the quality of patient care as they inspect surgical instrumentation throughout the decontamination, assembly, sterilization and storage of critical and semi-critical reusable medical equipment.
Mr. Huelsman explains that the number of digital visualization tools on the market has doubled since they purchased their original models more than 5 years ago. Even though previous generations of inspection microscopes, for instance, were great devices, SPD technicians were only able to see part of the picture of what was going on with their instrumentation. In 2018, Mr. Huelsman purchased stereo inspection microscopes that provided technicians with a 3D view of their instrumentation. The microscopes let the technicians view all sides of the instrument at once, clearly and effectively.
Not only did the 3D microscopes let his team better visualize trouble areas like box locks and jaws, which often harbor residual bioburden, Mr. Huelsman describes how they were able to look even deeper than they expected. With the latest visualization technology, technicians can now clearly see the tips of delicate instrumentation such as micro-eye instruments and ear picks that previous sterile processing technicians had no way to view. With the attached camera, technicians can take photos of what they see, and leadership can use the pictures in education programs and instrument management systems to highlight what the instruments look like and critical inspection points to improve overall quality.
Related technological advancements such as borescopes have made it easier for sterile processing technicians to internally inspect lumened instrumentation, shavers and flexible endoscopes with ease. Even smaller diameter (0.5 mm and 1.6 mm) borescopes let technicians inspect the lumens of the smallest 20- and 22-gauge ear suctions and robotic arms with ease, says Mr. Huelsman. All images are in high-definition and let the team capture photos, says Mr. Huelsman, so that they can share the images for educational purposes and show to leadership.
In addition to these innovations are the new visualization capabilities for take-apart arthroscopy shavers. Mr. Huelsman explains that most arthroscopy shaver companies state in their instructions for use that they must be visualized with borescopes. However, a shaver's challenging design make it hard to get a borescope all the way into the motor head of the handle. The question remaining for sterile processing departments was what to do if you find something in the motor head that cannot be removed.
Mr. Huelsman's department was able to locate an innovative take-apart shaver system that allowed easy access to the motor head and enabled complete visualization of all parts of the shaver. The suction part of the device is totally independent from the motor head to ensure cleanliness and is one hollow cannulation about 2 mm in diameter, which also makes brushing easy to ensure all contaminates are removed, says Mr. Huelsman. The shaver also works with large- and small-diameter shaver blades, so instead of having 2 shavers (1 for small joints and 1 for large) you only need 1 operating system for both purposes.
As a department tasked with ensuring the ability to adequately clean and sterilize all types of surgical instrumentation used in the OR, Mr. Huelsman believes visualization technologies such as these are the kind of game-changing innovations necessary to equip SPD technicians to lead their teams in the mission for zero patient harm.
5. Protein testing
Jeff Lawrence, MSN, administrative director of surgical services at Florida Hospital Tampa, nominates residual protein detection technologies as the top game-changing infection control innovation. Also known as Adenosine tri-phosphate (ATP) testing, Mr. Lawrence argues that ATP testing is a must-have for all OR, endo and SPD areas. Through their testing and auditing of the entire sterilization process, ATP tests have been key to his team preventing dangerous and costly SSIs.
Testing is performed by surface sampling/swabbing any surface, says Mr. Lawrence. A higher reading with ATP testing on a cleaned or sterile instrument indicates that it has biological matter or human cells still on it. Because AORN states that cleaning practices should be measured with qualitative measures (visual observation of cleaning process, visual inspection of cleanliness and fluorescent marking) and quantitative measures (cultures, ATP monitoring), these technologies are not only innovative, they are becoming best practice in infection control. Mr. Lawrence believes using a multidisciplinary approach to quality assurance with fluorescent marking and ATP testing ensures a thorough cleaning regime for surgical instrument reprocessing.
Recently, Mr. Lawrence's team took advantage of educating their SPD technicians on thorough cleaning practices in the decontamination area with immediate follow-up ATP testing. Having the ability to test and receive the results within seconds let his team identify post-cleaning presence of proteins on the some of the most difficult areas to clean. This heightened awareness of his technicians to their cleaning technique, says Mr. Lawrence, and provided opportunity to coach personnel in giving more attention to detail for challenging areas of instrumentation.
ATP testing technology and related auditing tools create a culture of accountability and high-quality standards throughout the SPD department, says Mr. Lawrence. "Every technician is challenged in every area," he says, "by spot-testing instruments in decontamination, assembly and auditing sets that have completed the sterilization process." ATP testing can even be extended to other work surfaces and equipment to ensure high standards of environmental cleaning are also maintained, he adds.
With the challenge of infection prevention ever before us, testing the limits of human ingenuity and scientific advancement, it is easy to forget that we're making real progress. If these innovations teach us anything, it's that we should never settle for the status quo of infection prevention. What worked 5 years ago is not necessarily the best option for today's microbial challenges. Collabor-ation with other leaders experiencing success in this area is the key to the future of infection-free patient care. OSM