No doubt about it, the most important function of infection control is to prevent infection from occurring in the first place. One of the areas where it is particularly vital is in surgery, because an open wound is so vulnerable to contamination. It goes without saying that the operating room (OR) environment needs to be squeaky clean. Instruments reused on surgical patients merit special attention. Enter the washer-decontaminator.

Ralph Basile, vice-president of

 marketing, Healthmark, St. Clair Shores, MI, told Healthcare Purchasing News how it should be done: "OR plays a role: steps should be taken to prevent blood soil from drying on instruments. Common steps include pretreating with spray or foam or just laying a wet towel over them to keep the soil moist so that it’s easier to remove later. Instruments should be prepared for decontamination by opening them up and arranging them in such a way that they can be handled easily and safely by decontamination personnel."

From the OR to CSS
From OR, soiled instruments go to central sterile supply (CSS) for cleaning, followed by decontamination in the washer-disinfector. The most important step is cleaning, because, if bioburden is not removed, it’s baked on during the disinfection cycle, making decontamination impossible.

Cleaning surgical instruments is an important responsibility, but unfortunately it’s not one always recognized or treated as such. "Decontamination staff’s efforts are vitally important, and they should be valued," Basile emphasized. "In a lot of situations, it’s not perceived as an important job; sometimes they’re the low man on the totem pole. It’s a little like working KP duty. It’s not a pleasant environment, even in the best of situations. They work with bloody, grossly soiled instruments and have to wear personal protective equipment (PPE), which is hot. The decontamination area should be cool for worker comfort because they need to wear all this PPE. Workers should be given constant training and provided good direction as to how the instruments should be cleaned and be advised as to what an important step this is in their facility."

From cleaning to mechanical disinfection
After manual cleaning comes mechanical disinfection. Todd Nielsen, national director of sales and marketing, infection control, Getinge USA, Rochester, NY, outlined what to look for in washer-disinfectors: "We focus a great deal on factors such as mechanical action, water temperature, detergents, and cycle times," he said. "State-of-the-art controls allow multiple programmable wash phases, which permit customized pre-wash, wash, and rinse phases, and detergent and lubricant dosing. Password protection can prevent inadvertent changes to cycle parameters. Other factors include ways to automate the loading and unloading process and wash-cart configurations that meet your specific instrument needs."

It’s not enough to simply take care of the equipment but it certainly helps, according to Nielsen. "Proper utilization of equipment is key, but equally important to a successful disinfection regimen are factors such as water quality, inorganic deposits, and pre-cleaning practices," he continued. "Mechanical washers, like any tool, are a reflection of our passion to do good work. When properly used and maintained, they can be the most effective tool in the disinfection process."

Nielsen noted that there are two validation benchmarks for mechanical washing. First is the washing efficacy of the thermal, chemical, and mechanical action within the machine. Second is verifying achievement of the machine’s programmed cycle parameters for any given cycle. "The first of these can be simply described as how good was the cleaning action?" he said. "Things like washing effectiveness are becoming more standardized through the use of widely accepted soil-removal indicators like the TOSI (test object surgical instrument) test. TOSI offers a measured, objective method to validate washability. The second benchmark is measuring and documenting cycle parameters: time and temperature through each rinse and wash phase, as well as timing and quantity of chemical detergent dosing. This documentation process can be automated with a cycle printer, similar to the paper-based cycle documentation that has been available for many years on sterilizers. Getinge also offers the capability to digitize these wash cycle parameters with our proprietary T-DOC software."

T-DOC simply validates the process, according to Nielsen. "Review of documentation can be one step in the validation process," he said. "Our T-DOC software automates the documentation process by interfacing with the microcomputer in Getinge washer controls and automatically logging data from the controls throughout the cycle. The data log includes the water temperature readings, phase durations, chemical dosing, and cycle errors. Careful documentation of the disinfection process has become the norm in many parts of Europe, but it has not been widely adapted in North America yet."

Jeffrey Pollis, group product manager, washing systems, STERIS Corporation Mentor, OH, outlined other key capabilities: Ease of use in an environment where staff training is a challenge; operator safety features that protect the CSS staff; high productivity from the system and its chemistries that can accommodate increased demand from the OR; and flexibility for wide application with a variety of reusable medical devices that require disinfection. "STERIS’s Reliance Synergy Washer/Disinfector has all these capabilities and more. It meets all evolving global standards, and we’ve incorporated features such as the independent monitoring function that acts as a duplicate sensor system and checks all the critical parameters of washing, disinfecting, and drying," he said.

STERIS’ monitoring system is called Synergy. "For the Synergy system," explained Pollis, "critical parameters are monitored and any deviation will alert the operator and be displayed on the touch screen. In addition, the independent monitor will double-check these same parameters and will alert the operator and display results on the touch screen as well. Our washers are capable of connecting to tracking systems and downloading cycle information to a remote terminal for observation and documentation."

The ever-present concern of strained budgets also plays a key role, Pollis pointed out. "The two major concerns of our customers are optimizing their productivity and providing a low lifetime cost of ownership," he said. "Their instrument processing volumes are rising, but their budgets may not be, so they require washing equipment that is as productive as possible while also having a manageable total cost of ownership."

STERIS SY2000-4000  Chemistries

Visual inspections
Nielsen quoted from AAMI standards on how facilities should monitor the effectiveness of their decontamination equipment. "AAMI ST35:2003, Section 7.4.4, establishes the role of visual inspection in the disinfection process and requires device manufacturers to provide testing mechanisms to standardize further verification of cleanliness," he noted. "Absent an indicator, like the biological indicators used in sterilization, to validate disinfection objectively, visual inspection is the best means currently available to regularly inspect for cleanliness."

Basile noted that the AAMI standard has longevity. "The visual standard is the standard for the industry and will never be replaced, but, because it involves the human element, there is a degree of subjectiveness," he observed.

Pollis countered: "Although visual inspection remains the standard, it does not quantify the effective removal of bioburden. All efforts should be made to reduce manual cleaning in the CSS department, due to two major issues: the risks of exposure for the CSS staff and the variability of cleaning results."

However, any equipment gets out of calibration with use, Basile maintained. "Oftentimes, washer-disinfectors are used practically 24 hours a day. Parts can loosen, tubes can get brittle, and so over time the machine may no longer be as effective as it should," he said. "If instruments were coming clean last week and this week they’re not, the machine is not performing the way the manufacturer intended it to perform, and it’s time to take a look at what’s going on."

Getting cozy with TOSI
Basile noted that the TOSI test serves as an adjunct to the visual standard. "Because each and every TOSI is identical, use of the test provides the same cleaning challenge to the washer each every time, providing an objective measure of cleaning effectiveness," he said.

The TOSI test comprises three components: Test soil; a stainless steel plate, and a transparent plastic holder. The test soil is made up of the components of blood that represent the greatest cleaning challenge. The stainless steel plate is scratched to mimic the uneven surface of surgical instruments. The plate is mounted in the holder at an angle, providing a gradually more difficult cleaning test from one end to the other. At the narrowest end, the TOSI is analogous to the areas of an instrument that cannot be seen, such as box locks. The holder is transparent so the user can evaluate cleaning efficiency by sight. The test kit includes a performance log and an interpretation guide. A Healthmark representative helps the facility’s CSS staff to get a performance baseline. If, over time, a washer is not getting the TOSI clean, staff will know the machine needs attention.

Sometimes stains will be left behind on instruments after cleaning and disinfection. What may appear to be a rust or water stain might really be a blood stain. Healthmark’s Hemo-Check is an easy-to-use-two part test kit that can detect as little as 1 micron of blood, indicated by a color change.

Keeping a paper trail
More stringent regulations may be motivation enough to keep an audit trail on file of equipment performance, according to Basile.

"JCAHO is becoming more aggressive in battling nosocomial infection," he said. "If an issue comes up, records compiled over a period of time can demonstrate whether the equipment is functioning properly and whether staff have been diligent about monitoring proper performance."

Added Pollis, "You need a record of when devices were processed and whether cycle parameters were met, in order to release the devices in that load for further processing."

Maintaining accurate and detailed records offer multiple benefits, according to Nielsen. "Records validating processes and adherence to standards potentially serve many purposes," he observed. "But they all tie back to patient and staff safety. Perhaps the most dramatic of these is the possibility to better manage risk and liability issues. Evidence that standards, practices, and process controls are being employed can be a powerful factor in helping to disprove accusations of neglect. On the lower end of the ‘profile scale,’ validation and documentation data also help sterile-process managers to understand and improve their equipment, regimens, and staff."

On the horizon
At least two major developments loom in the area of cleaning and disenfection. "There is a movement to enzymatics," observed Basile. "High alkaline detergents can be tough on a lot of materials. Enzymes break down blood soil, but, because it’s a biological process not a chemical process, it needs time to work. That time needs to be allowed for in cycle parameters. Every manufacturer seeks to improve efficiency of cycle, use of water, and the time factor."

Pollis asserted that American standards may have a European influence in the future. "Independent monitoring is an outgrowth of European standards," he explained. "And it may have a larger presence in the United States in the future. Although there is no consensus regarding the use of indicators for washing systems, their use originated in Europe and is being considered in the United States. Future changes will involve control enhancements that provide educational and operational support to operators."