Sterile processing gears up for quality performance

Serious challenges continue to test central sterile/sterile processing departments (CS/SPDs), especially when it comes to getting endoscopes clean prior to sterilization. It’s a complex, painstaking process that requires multiple steps and plenty of time to do it right.

“When this happens, the FDA steps in and we then have a laser focus on not only the cleaning difficulties, but also the actual device design,” said David Jagrosse, CRCST, CHL, IAHCSMM Past-President and Central Service Manager for Middlesex Hospital in Middletown, CT. “The problem is this should have occurred proactively. Many CS and Endo technicians and even some independent groups studying the issue (e.g., Ofstead & Associates, Inc.) have highlighted the difficulty in cleaning those devices, even when the IFU was followed. Once it did come into national spotlight, the industry had a tremendous response. It was a top to bottom re-review of the entire process. Manufacturer designs were re-studied and the 501(K)s were reexamined. Many of these manufacturers are rethinking their designs for better outcomes. A lot of vendors that supply cleaning devices and transport containers for endoscopes also rapidly developed new products to the market.”

Do you see what I see?

Healthmark Industries is one of those vendors.

“According to AAMI Guidelines (ANSI/AAMI ST79) ‘visually clean’ remains an important standard for cleaning; but if you cannot see a surface, you cannot determine whether it is visibly clean,” said Ralph J. Basile, Vice President, Healthmark Industries.

After research repeatedly showed “thoroughly cleaned” lumened devices (e.g., flexible endoscopes, suctions, reamers and shavers) remained contaminated, Healthmark Industries partnered with risk management clinical engineer Jahan Azizi, who was then working at the University of Michigan Health System, to come up with a solution.

“Jahan was using a $250,000 video tower in order to look inside of devices. We knew we had to come up with a tool capable of doing the same thing but for a fraction of the price, in order to be a viable option for our sterile processing customers,” Basile recalled. “We first worked with fiber optics, but found the technology had real challenges, including mediocre image quality and very delicate construction. We looked for an alternative and that alternative was a small digital camera chip mounted at the tip of a long, flexible shaft. This technology delivers an amazingly clear image, in a design that is robust.”

Healthmark considers its small bore Flexible Inspection Scope (FIS) a disruptive technology that technicians are using to identify internal contamination that could have bypassed detection previously. “Until we introduced the FIS, there was not an affordable tool for this purpose,” Basile said. “Not only is the ability to look inside of a device a critical new capability for those responsible for reprocessing medical devices, but the use of state-of-the-art digital camera technology is a critical leap forward in image quality and in functionality. Not only can the internal channels of a device be directly inspected, but that inspection can be documented for later use and reference.

“Most recently, published studies by Ofstead and Associates, document the use of the FIS to look inside of flexible endoscopes,” Basile continued. “One of the things their research brought to light was finding residual simethicone (antiflatulent) in GI endoscopes. Simethicone is water insoluble/hydrophobic and not easily detected — even to remove by detergent and water. It was by use of the FIS that Cori Ofstead and her team identified that a substance was remaining inside of the channels of GI scopes. They used the FIS to visually extract samples of the substance and ultimately determine it was simethicone.”

ProReveal, a fluorescence-based protein detection system, is another relatively new and disruptive technology from Ultra Clean Systems that SPDs can use to find invisible protein residue on instruments prior to sterilization. After cleaning the instruments the tech places them in a drawer and sprays them with a reagent. The system then bathes the instruments in fluorescent light to detect any invisible, hidden proteins left behind. Next, the system generates a digital image to show exactly where the hidden protein lies so it can be removed. Also, with every test, new data is collected over time to reveal trends and information that managers can use to identify areas for improvement.

Tom Overbey, Marketing Director for Ultra Clean Systems, says facilities that do not check for protein or still rely on swabbing should consider making changes. “My first-hand observation from many different facilities is that SPDs are not checking for protein,” Overbey said. “In certain circumstances, say when there is an instance of a known infection spike in a facility, then a swabbing sampling audit will be undertaken. But, data supports the fact that swabbing is random, lacks sensitivity and is prone to false-positives because you must assume that you are actually desorbing protein off an instrument and onto the testing swab. The guesswork is even ‘guessing’ where to swab on the instrument because you can’t see protein.”

ProReveal generates data that can also be used to identify malfunctions in detergent delivery, brand or performance characteristics, breakdowns in washer spray arms, temperature and moisture issues, noncompliance among decontam staff, overloaded or incorrect trays, and other information that can pinpoint problems for correction. “The basic principle is the more you test for protein, the more precise the performance profile will be,” Overbey explained. “In essence, generating more plot points over time yields more identifiable patterns in the quality of instrument reprocessing, good or bad.”

Last November, STERIS introduced a complete line of sonic irrigators and ultrasonic cleaners that have “exceptional cavitation, targeting and removing exterior gross soils from crevices and irregular surfaces, on the simplest to the most complex medical devices,” asserted  Katilin Slaper-Hawranko, MBA, Associate Product Manager, Ultrasonic systems and Reprocessing Sinks, STERIS Corporation. “SPD staff are leveraging the power of sonic irrigators to help supplement manual cleaning and deliver more consistent cleaning outcomes prior to the next step in the cleaning process. Sonic irrigation not only exposes external surfaces of devices to ultrasonic energy, but also exposes internal channels. The cavitation pulses through lumens when connected and provides a high-pressure flush to remove soils that may be lodged in channels.”

STERIS’s InnoWave Pro Sonic Irrigator reprocesses 60 lumened instruments or up to 66 lbs. in every cycle while increasing safety with ergonomic features that improve loading of the tray elevator. “SPD Technicians often load heavy trays into ultrasonic cleaners, but by using the multi-stop tray elevator, ergonomic loading can be achieved on each and every level,” said Slaper-Hawranko. “Units featuring thermal disinfection offer the added assurance of safe handling after cycle completion. Top level light indicators keep technicians informed of cycle progress when multi-tasking throughout the CSSD. During audits, CSSDs can be asked about unit monitoring. By having a Sonic Irrigator that monitors the important parameters of the cycle, including, but not limited to temperature and chemistry dilution, questions can be quickly addressed.”

Taking sinks seriously

Effective instrument-cleaning — the first critical step in the decontamination process — requires having a good sink. Unfortunately, some departments still view reprocessing sinks as less important than other sterile processing equipment. When that happens, staff suffer and so do outcomes, potentially.

“Oftentimes restaurant-style sinks were installed in the sterile processing area with sink basins that are too deep thus causing back problems for techs,” said Todd Campbell, President, TBJ Inc. “The sink bowls were not configured correctly to accept an instrument tray thus requiring techs to turn the tray 90 degrees to fit it in the sink bowl causing additional hazards and injuries to techs.”

Some sinks, Campbell added, are just an add-on or a bonus that was included in the washer/sterilizer manufacturer’s package deal. “For years techs have been forced to deal with inefficient sink designs because there were basically few options available.”

TBJ’s height-adjustable sinks allow techs of any height to work comfortably and more efficiently. Other features include a hydro-force system that re-circulates water in the pre-rinse sink to reduce gross debris manual pre-cleaning. The dual-purpose ultrasonic sink bowl with safety overflow sensors and overflow drains, works as an in-line ultrasonic cycle or as a standard sink bowl. Push-button automatic programming fills the sink bowl to a pre-determined water level and injects detergents and enzymatics at a pre-determined amount as the water fills the sink bowl. Water temperature can also be programmed and monitored and it comes with lumen and cannulated instrument flushing ports, scope pre-cleaning options with a built-in leak testing port, dual flushing ports, scope serial number and user bar code scanning, and hard-copy documentation.

Dan Gusanders, President and Founder of Pure Processing sells another height-adjustable sink for sterile processing departments and also notes the importance of making sure staff is safe and comfortable while working. “The need to provide a workplace free of ergonomic hazards is in high demand. Resources lost due to injury, can be easily avoided by providing good ergonomics in the department to prevent musculoskeletal disorders,” he said.

Cleaning instruments is a stressful job and Gusanders says today’s minimally invasive instruments, robotic devices and other complex technology now require techs to stand and work much longer at the sink. “SPD staff bears the responsibility of 100 percent sterile instruments, 100 percent of on time,” Gusanders said, adding that inadequate systems makes the work more difficult and mistakes more likely. “Poor workplace design can contribute to problems such as cross contamination, damaged instruments, excessive processing costs, inefficiency, and injury. People make errors, which lead to accidents, and without changing the system, problems will continue.”

As Campbell pointed out earlier, restaurant-style sinks, which are still in use in some SPDs, don’t work well at all. “Many sinks in departments are really deep, kitchen utility sinks, designed many years ago with the goal of cleaning pots and pans. A lot of departments are stacking bins on top of each other to raise the work level,” said Gusanders. “Pure Processing offers tools at the sink to improve consistency and greater compliance: height adjustable stainless steel sinks with pegboards and shelving to take advantage of the wall space and leave a clear counter top to stage instruments, optimizing process flow, keeping organized, increasing productivity, ergonomics, and safety in the department. The PureStation sink inserts have been specifically designed to address ergonomics and reprocess instruments according to IFU. We have worked with over 1,000 facilities to improve ergonomics with this sink insert solution to date.”

Selecting the suitable sterilizer

Now, with more ambulatory surgical centers cropping up, the need for compact, onsite sterilization equipment is also growing. Cathy Klein, Instrument Processing Product Manager, Midmark, says the Ritter M11, a tabletop sterilizer with a spacious chamber, was designed to boost sterilization output by reducing time and effort without sacrificing effectiveness.

“With any Ritter sterilizer, simply load it, set it and forget it. Select the cycle and the time is set for you,” Klein explained, noting that the products are used most often in outpatient facilities. “Press ‘start’ and the sterilizer will fill with the correct amount of water. Once the sterilization process is complete, the door opens automatically and quietly to dissipate the steam, providing fast drying for your instruments. In the outpatient setting, convenience is important and space is at a premium. Sterilizers must be compact while still processing enough equipment for the facility’s demands. The M11 offers an 11”x18” chamber, perfect for accommodating larger packs and instruments.”

Jeff Wiser, Technical Service Engineer, 3M Infection-Prevention Division, says sterile processing teams are stressed about having to plan for long cycle times when using EO sterilization for flexible endoscopes. Wiser said that’s because the “superior penetrability properties of EO as a sterilant requires extended aeration times.” One way SPDs get around that is to implement a tiered approach to the frequency of EO sterilization, purchase or rent additional endoscopes or add additional EO sterilizers to maintain surgery and procedure schedules and accommodate reprocessing times.

“3M Steri-Vac GS Series, cleared by the FDA in 2015, are ethylene oxide sterilizers used for terminal sterilization of heat and moisture sensitive devices,” said Wiser. “There is no restriction of lumen length or diameter and is compatible with up to 20 lumens per load. As reported in peer-reviewed research publications, or research papers, at least four facilities have controlled CRE outbreaks isolated to duodenoscopes by utilizing EO terminal.¹ The evidence was enough for the FDA to suggest that facilities may want to consider EO sterilization as a supplemental measure for reprocessing of duodenoscopes to improve patient safety.”²

Steri-Vac’s notable features include an internal processor that automatically controls and independently monitors pressure, temperature, and relative humidity to ensure sterilization conditions are maintained throughout the sterilization cycle; a state-of-the-art proprietary humidification process that adds, measures, adapts, and controls %RH to accommodate different loads and packaging materials to achieve proper humidification prior to EO gas injection; and individual, scannable 2D barcode cartridges encrypted with the 3M Steri-Gas EO Gas Cartridge’s catalogue number, lot code (expiration date) and nominal fill weight.

3M’s Attest System Advantage, a one-stop-shop solution launched last July for sterile processing departments, offers a comprehensive sterilization product portfolio across all modalities of sterilization (Steam, VH2O2, EO), compliance and best practice education and training with IAHCSMM-certified consultants, and tech service and support teams. Steve Kubler, 3M Sterilization Assurance Marketing Manager, says Attest’s 1295 Biological Indicator 490H Auto Reader for hydrogen peroxide sterilization and variety of support services, should help SPD’s improve efficiencies by standardizing processes and workflows.

“We know that SPD managers and staff have to balance processing speed with sterilization effectiveness; we want to make sure that no SPD has to sacrifice one for the other by releasing medical instruments without sterilization monitoring verification,” Kubler said. “We are continuously pushing our clinical and lab teams to decrease incubation and readout times of our biologicals in order to help drive efficiency and provide peace of mind for our customers — and ultimately the patients they serve. It is our hope that this kind of product and resource coverage — from one provider — eases some of the daily pressures SPD managers and staff face daily, so they can focus on consistently delivering the highest standard of care for every patient.”

Protecting SPD staff from the harmful effects of ethylene oxide, which is highly flammable, is also mandatory and requires a dependable monitoring system. The National Fire Protection Association (NFPA) standards state that EO/EtO should be kept in a flammable storage cabinet but that alone isn’t always foolproof.

“The problem is that EtO may seep through the seals of the single use EtO cartridges, which in a well-ventilated space is not a major issue,” explained Lisa McCombie, Marketing Manager, ChemDAQ Inc. “However, in the confines of an unvented flammable cabinet, a little seepage can very quickly give rise to a buildup of hazardous concentration of EtO vapor, until it is released when the door is opened and someone reaches in to get an EtO cartridge. EtO has no odor until hundreds of times higher than the OSHA permissible exposure limit; the odor threshold for EtO > 400 ppm. We do not have any firm numbers but we estimate that over a third of all flammable cabinets for EtO are not actively vented. Even if there is active ventilation, it may be inadequate, and we have seen cases where the ventilation fans have failed or breakers have tripped after storms without warning. One of our customers tested a number of EtO cartridges and found that about half of them had significant seepage rates.”

ChemDAQ’s EtO sensor and PAA sensor contain proprietary filters to improve selectivity and reduce false alarms. They also come pre-calibrated and swapping out the sensors is quick, easy, and does not require any tools, instrument adjustments or sensor hydration steps. “Like most of the better brands, our monitor provides continuous monitoring with a resolution of 0.1 ppm — well below the OSHA PEL of 1.0 ppm for EtO and hydrogen peroxide,” McCombie said.

Clever case carts & containers

Keeping the OR on schedule with instruments that could be delivered in a sterile package consistently and reliably and reducing SPD’s operating expenses were two important goals that Aesculap had in mind when developing its rigid SterileContainer System, says Ed Nuber, Director of Marketing, Central Sterile Products and Services, Aesculap Inc. Another challenge common to SPDs that use containers is properly following the IFU. To help alleviate any confusion and maintain workflows, Nuber says Aesculap’s IFUs come with illustrations, a How To Video Library, in-service placards for the SPD and OR on Prep and Pack and Aseptic presentation, and onsite in-service by specialized Aesculap staff.

“The Aesculap SterilContainer System is a disruptive technology because it transitions the SPD from simply providing instruments to providing a surgical asset management solution that protects and organizes instruments in a durable sterile package, that maintains the sterile barrier through transport and storage,” Nuber asserted. “The alternative to the Aesculap SterilContainer System is blue wrap, which is susceptible to punctures and tears, and often is the cause of OR case delays.”

“ONE TRAY is a disruptive technology that takes current post decontamination sterilization processes from hours to minutes,” said Mike Faulkner, President of Sales, Innovative Sterilization Technologies LLC. “With ONE TRAY, facilities can react seamlessly to changing surgery schedules, process vendor trays quickly & efficiently, avoid unnecessary purchases of redundant instrumentation, and eliminate the need for IUSS. ONE TRAY reduces sterilization times from hours to minutes because our technology allows us to eliminate both the dry and cool times; where our competition requires both. ONE TRAY allows facilities to react seamlessly to changing surgery schedules because they no longer have to wait hours to sterilize instrumentation. ONE TRAY is ready to go in approximately 20 mins (post decontamination) vs. all others taking approximately two hours (post decontamination). We get feedback daily from facilities about their increased efficiencies and productivity, the positive impact on patient care from eliminating the need for IUSS, as well as huge financial savings from reducing the need to purchase redundant instrumentation, reduced utilities, and increased efficiencies.”

The Turbett Instrument Pod, a surgical container that received FDA 510(k) clearance last January, is an innovation that simplifies and reduces the various steps technicians take to get instruments ready for use in the OR. “Customers — both in SPD and OR — are bogged down by the chores in a time when everyone in the health industry needs to be more efficient,” said Rob Turbett, President, Turbett Surgical. Turbett said they designed the product using direct feedback from the end user. “We brought in focus groups from the OR and SPD to look at each of the steps and decided the best way to approach the design — using AAMI ST79 and AORN Guidelines as our rule book,” he said. Unlike containers that come with reusables, the Pod operates using a single filter cartridge with a new seal for every patient. “We have just one pathway for pathogens to enter compared to other containers that have as many as six — and ours gets a new gasket with each use. Because our filter is in the door, it can be removed and inspected by the surgical technician before they gown and glove. After they are sterile, they can remove their trays. That makes the Instrument Pod a truly one person operation.”

The container also reduces turnover time and prevents holes in wrap at the same time. “We routinely take 15 minutes off a room turnover and have eliminated delays due to holes,” Turbett asserted. “Small rigid containers eliminate holes, but they do not help at all with improving efficiency. With our Instrument Pod, we do things once instead of 15 times needed for wrapping or small containerizing. Our record time for setting up for a total knee is 55 seconds. We also do a fabulous job reducing time in SPD with all the mechanical steps we save, such as eliminating 60 percent of the instrument lifts. We also just received a validation for a ten minute dry time. This takes 20 minutes off a routine cycle, allowing the SPD to achieve much greater throughput with their sterilizers.”

When it comes to case carts, Tom Hillebrand, Vice President, Sales & Marketing, Pedigo Products Inc. says they’re the “critical link between clean and dirty” and choosing the right model and design requires some thoughtful questioning: “Is there interior space for all the necessary instruments and supplies? What space do you have to store the carts — what footprint do you need — short vs. tall, narrow vs. wide? Is the cart easy to push when fully loaded? Some hospitals tow one or more carts with a tug device or just link two or three carts for manual push-pulling. Make sure the chassis of the cart and the bumper design are designed for the stress. A specifically designed trailer hitch system is recommended.

“Caster failure is a common problem with case carts,” continued Hillebrand. “The extreme temperature of the automated cart washer will evaporate the grease in the casters. Hospitals should specify a sealed, maintenance free caster with stainless steel bearings. Additionally, consider how quiet the casters are during transport.”

Some of the Pedigo cart features include biohazard labeling mechanisms that indicate when clean, dirty or empty; exterior preference card holder/operating room destination labels; external security latch to keep the cart closed when contents are sterile; roll-out shelving with a shelf locking system for easy, safe loading and unloading. “Certainly some carts are built better than others. Take your carts for a test drive. Have the sizes that you are considering shipped in for your staff to load and push. See how they fit in your space.”

Protecting your investment

Surgical devices are expensive. Here are some tips for keeping them in good working condition.

“[Protecting instruments] is critical during the decontamination process, during assembly of trays, during sterilization — and it doesn’t end there. It’s also important to keep instruments protected during storage and transportation,” said Lindsay Brown, Clinical Educator, Key Surgical. “At any step in the process, an instrument or sterile pack could be compromised. When instrument protection is discussed, often we think solely of products such as instrument tip protectors but we should consider the process as well. Instruments are also protected when SPD professionals handle the instruments properly, when OR staff pre-clean instruments properly, and when the correct packaging material is used according to manufacturers’ IFUs during sterilization. For example, if a cellulosic material is used as a sterile wrap in hydrogen peroxide sterilization, that material will absorb the sterilant and prevent it from contacting the instruments inside, therefore preventing sterilization. This is just one example of improper protection during sterilization.”

Key Surgical has a variety of tip caps available in more than 100 sizes and styles: round, flat, osteotome, tapered, scope, retractor, twin, MIS and caps for delicate instrumentation such as skin hooks. The X-ray detectable, latex-free caps come vented, non-vented or with Airflow to assist with removal after sterilization. Key Surgical’s Instrument Sleeves, made from medical-grade paper, protect blades, osteotomes, and various hooks. The Key Surgical DuraHolder IPS also provides the same function.

“Instrument protection and care is like health insurance for instrumentation,” Brown asserted. “Routine maintenance, proper care and protection, etc. prevent larger issues and damage from happening which can get costly. I’ve heard testimonies from customers across the U.S. about how proper protection and care has dramatically impacted repair and replacement costs.”

When surgical instruments break, or perform poorly from improper handling in the SPD or the OR, or just from normal wear and tear, having a solid maintenance and repair plan in place will maximize device-longevity.

Amanda H. Coss, CSPDS, CSPM, CRCST, CIS, CHL, National Education Coordinator, Mobile Instrument Service & Repair Inc., says rigid and flexible endoscopes are particularly vulnerable to injury. “The miniaturization of the optic system makes smaller devices more prone to damage during use and more costly to manufacture and repair,” Coss said. “End users do not realize the damage they can cause when handling rigid scopes. Rigid scopes contain delicate glass rod lenses and complex optics that even a slight amount of pressure can cause to separate or break. Flexible endoscopes undergo a more labor-intensive reprocessing and anytime people are involved in transport and cleaning an awkward device, there is increased risk of unintentional damage. Some of this can be caused by design, but majority is caused by unintentional user error. Looking at cameras and couplers, we see over 90 percent of repairs are the result of user-caused damage. The cables are kinked, cut, burned, autoclaved, torn, dragged, etc.

“One bright spot is the direct, positive impact that education and awareness program can have on repairs,” continued Coss. “An all-inclusive, well rounded education program will include all hospital staff handling the equipment ranging from the surgeons, nurses, scrub technicians, transporters, and sterile processing staff. Proper care and handling of this vital, yet delicate equipment, is a must to reduce repair and increase the awareness of just how fragile the equipment is. Aside from embracing preventative maintenance, the real key is to reduce repairs. Our advisory and educational curriculum is designed with that goal in mind and if applied and followed, can really make a difference.”

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