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It’s safe to say that no other environment trumps healthcare in regard to the importance of following instructions and proper protocol. After all, failure to do so can have dire, and perhaps even deadly, consequences. Although many patients may not know sterile processing by name, or even its critical function, they are nonetheless placing their trust in the hospital that the instruments and devices they come in contact with over the course of their stay will be cleaned and sterilized, and in good working order.

Unfortunately, when it comes to safe and appropriate use of the myriad detergents and disinfectants used in the SPD, some sterile processing personnel, despite their good intentions, are dropping the ball by failing to use the products as they were intended — and placing themselves and the patients at risk as a result.

"It’s a problem that continues to exist," confirmed Natalie Lind, educational director for the International Association of Healthcare Central Service Materiel Management. "The instructions for use are clearly printed on the label, but that doesn’t mean they are being read or understood, or followed appropriately."

While reading product instructions may, in theory, be among the most elementary tasks imposed upon CS technicians, numerous factors may weigh into their willingness to pour product contents without first poring over the usage instructions.

Making sure surfaces are clean and totally disinfected should be a priority

"I believe that staff and facility managers, in general, struggle with the concept of following label directions because they are under-staffed, under-trained, and under constant pressure to get things done in a timely manner," noted Jason Welch, a microbiologist for Spartan Chemical Company Inc., Maumee, OH. "In addition, they are dealing with microscopic organisms – things that can’t be seen with the naked eye."

Welch went on to explain that because they can’t be seen, it’s impossible to show during demonstrations that proper disinfectant use has eradicated a microorganism. "Proving that a surface is clean and dirt-free is much easier to see and believe," he continued. "Therefore, [some] people believe that just wiping down a surface and removing surface soil is enough."

Deviating from manufacturer instructions can have serious consequences, both for CS staff and patients, sources warned. Failure to use appropriate personal protective equipment when handling disinfectants and detergents can result in chemical burns and damage and irritation to skin, eyes, lungs, and mucous membranes.

Kimberly-Clark Pre-Cleaning Detergent Spray helps keep devices moist (above) Kimberly-Clark Multi-Enzyme Detergent

Lind said part of the problem is that CS technicians may mistakenly assume that some products, such as low-level disinfectants and detergents, are less toxic than products used for higher-level disinfection and, as a result, may let their guard down with PPE and pay less attention to manufacturer instructions for safe, appropriate use.

"Some may assume that when using detergents and low-level disinfectants all they need is a rag and a bucket of solution," Lind explained. She went on to say that technicians may view some products and chemicals similarly to the cleaning products found in their homes. "They may assume that they’re more [benign], which isn’t necessarily the case. They need to understand that all these different chemicals used in CS come with safety hazards and need to be used with caution. That means using the appropriate PPE and following the instructions exactly for each product being used."

Further muddying the waters is the ever-growing list of chemical solutions being offered by different manufacturers – each of which may perform slightly different than the competitor’s and require different instructions for safe use. "Instrument reprocessing is complicated and dependent upon every step of the process being performed correctly and consistently to provide optimal outcomes," said David Parks, general manager, global business management, Kimberly-Clark Health Care, Roswell, GA. "There are multiple manufacturers with varying products available, [and] each of these products has specific instructions for use. Complying with the specific instructions is necessary to prevent inconsistency in the cleaning process."

Introducing new products can also add to the confusion. As Cynthia Spry, international clinical consultant for Advanced Sterilization Products, Irvine, CA, put it, "A facility may switch to a new product and the technician or person responsible for disinfection may assume that the exposure time is the same for all products." Because different products call for different processes, she stressed the importance of carefully adhering to the instructions for use for each product.

Another area of danger lies in the mixing of incompatible chemicals. Some chemicals, such as chlorine bleach and ammonia, produce a highly toxic gas if combined. "The mixing of chemicals in a way not specifically recommended by the supplier can cause unexplained reactions and unexpected effects, such as heat generation, evolution of gas, and the precipitation of residue in washers and tubing. It can also diminish the effectiveness of the chemistry," explained Nancy Kaiser, product technologies senior manager, STERIS Corp., Mentor, OH.

STERIS Instrument Cleaning Chemistries

Even seemingly similar solutions can pose a danger if mixed. One SPD manager said he witnessed a technician draining the contents of one near-empty solution and then adding a different product to the same basin. Although the two products were developed for essentially the same purpose and the technician certainly meant no harm, he said that the two different brands contained incompatible ingredients.

"Again, because virtually every chemical solution has its own risks, it’s important to read and completely understand the instructions for use," said Lind. "If the instructions aren’t clear or there’s any confusion, ask the manufacturer for a response, preferably in writing." The product’s Material Safety Data Sheet, which is a compilation of data required under the OSHA Communication Standard on the identity of hazardous chemicals, health, and physical hazards, exposure limits, storage requirements, and precautions, should also be readily available to technicians and followed to a T.

David Narance, R.N., CRCST, reprocessing manager/clinician for Mansfield, OH-based MedCentral Health System, believes it’s not enough to just have hard copies of MSDSs. His department scans in every MSDS and contracts with an Internet service provider that allows technicians, Hazmat officials and others to access the password-protected information from outside the department.

"We realize the impact that hazardous chemicals can have on staff and the benefit that these MSDSs have on safety and effective product use. But we also realize there might be situations, such as evacuations, that make it difficult for us to access those hard copies," he explained. "This allows us to pull up that information whenever and wherever it’s needed."

Narance takes other safety precautions as well. He requires that all CS personnel undergo physicals and blood tests upon hiring (to serve as a baseline) and then subsequent blood work-ups on an annual basis. "This is mandatory because we want to be sure our employees aren’t getting sick from chemicals."

Spectrum Spectra-Moist spray-on lubricant helps prolong instrument life Post-procedure, instruments may be covered with a simple wet towel to prevent fluids from drying on devices.

Aside from the dangers that misuse can pose to technicians, the potential for placing patients at risk for infection due to misuse of detergents and disinfectants can also not be overlooked. While CS technicians are taught that dirty instruments cannot be sterilized, they may not always recognize how even seemingly minor deviations to manufacturer use instructions can jeopardize disinfection and subsequent sterilization.

For starters, safe, effective use hinges on selecting the right product for the right purpose. Rick Schultz, president and CEO of Stow, OH-based Spectrum Surgical Instruments Corp., said it’s not uncommon for him to find sterile processing personnel using general housekeeping products that weren’t designed for use on surgical instrumentation.

"One of my top questions for sterile processing personnel is ‘Are your solutions safe and being used for what they’re intended?’" Schultz said. "Is the lubricant you’re using neutral pH? Is the soap in the sink meant for use on instruments? If in doubt, look for the words ‘surgical instruments’ on the label."

Beyond using the appropriate product, it’s also imperative that technicians understand just how critical water quality, dilution ratios and contact time, among other factors, impact the solution’s effectiveness. After all, if a detergent or disinfectant is unable to effectively remove soil, blood and bioburden, the sterilization process will be adversely affected.

As Martha Young, senior technical service specialist, Sterilization Assurance, Medical Division, 3M Health Care, St. Paul, MN, pointed out, proper preparation of a solution is one function whose importance cannot be overestimated. She explained that chemists developing solutions for use on surgical instrumentation and medical devices have done their due diligence to determine the most effective concentration and contact time for a particular product. "Over-dilution and failure to use a solution for the correct contact time and temperature will have a direct impact on the solution’s effectiveness," Young explained. "In addition, the solution should be tested with an FDA cleared test strip or chemical monitoring device before each use to ensure the concentration of the active ingredient is above the product’s minimum effective concentration and it can be used effectively."

Medisafe 3E-Zyme

Under-usage may also "increase the potential for cross contamination and the development of resistant strains of microorganisms, as has occurred with antibiotics," added Tina Bramlett, sales supervisor for Medisafe America LLC, Tampa, FL.

Safe, effective use of enzymatics is one area that often lacks solid education and understanding from its users. Some technicians, for example, view enzymatics much like they would a soap, and as a result, don’t give the products enough time to do their job effectively. Ryan Meek, product line manager for Ecolab, Inc., St. Paul, MN, said a common approach tends to be splashing an enzyme solution on the instruments while brushing off the soil. "Enzymes, by their nature as a catalyst, need time to complete the reaction of breaking down soils. This time comes through soaking," he said, adding that Ecolab works to educate customers that time spent brushing could be used in other areas and that simply allowing instruments to soak with an enzyme will improve soil removal.

Of course, CS professionals should also have a solid understanding of the extent of their enzymatic product’s capabilities and limitations. Although many use some form of enzymatic detergent, they may have little knowledge of the components of their product or efficacy. "Not all enzymatic detergents are the same or accomplish the same level of cleaning," explained Parks."Caregivers should know which contaminants/soils may be present on their devices and look for an enzymatic detergent that has data to show its efficacy in removing those soils."

According to Barb Smith, operations manager, consumables, Getinge USA, Rochester, NY., the use of multi-functional enzyme products with enzymes that attack more than one kind of residue (i.e., Proteins, fats, starch, cellulose) is one trend that has increased over the past five years. The most significant trend, she said, "is the development of super-concentrated products that provide similar or superior cleaning in smaller packaging." Aside from cutting down on storage space requirements and reducing packaging waste, Smith added that these products also offer an added bonus of eliminating heavy, hard to handle 30- and 55-gallon drums. Still, as with other solutions, safe, effective use requires careful attention to use instructions. [Note: While proper use of enzymatics can simplify the cleaning process by breaking down different types of bioburden, Schultz stressed that moistening agents (and even the simple placement of a wet towel over an instrument tray immediately following a procedure) can also be highly effective in promoting effective cleaning by preventing blood and bioburden from drying on instruments.]

To help ensure that disinfectants and detergents, regardless of their type, are being used for the recommended time, Lind suggests using inexpensive kitchen timers if technicians don’t allow the solution to work for the recommended time.

Cidex OPA from Advanced Sterilization Products

Using more product than is recommended is another risky – and costly – practice, increasing the risk of leaving behind residues and damaging instrumentation. Still, some technicians may assume that increasing the amount of solution will raise its effectiveness. "Not true," warned Schultz. "If you have extra-bloody instruments, that doesn’t mean you should use two or three times as much product. If the label says to use one ounce, that’s all you should use."

A research study conducted by clinical associates at ASP underscored the importance of correct enzymatic detergent mixing and rinsing. The study found that breaches in these practices result in a visible stain in the presence of CIDEX OPA. This reaction, according to Spry, emphasizes the importance of diluting and using enzymatic detergents exactly as directed by their manufacturers to reduce bioburden and residual amounts of high-level disinfectant on flexible endoscopes.

Sources also pointed out that to maximize solutions’ effectiveness SPDs should, ultimately, be using reverse osmosis or demineralized water, whenever possible.

"Better awareness of the impact that water quality has on the overall process is very important," noted Getinge’s Smith. "The use of reverse osmosis or deionization water systems for the final rinse can make a big difference in the success of the cleaning process and instrument [lifespan]."

Added Schultz: "If tap water is being used, be sure you know how hard that water is," he continued, adding that when cleaning sensitive devices, such as scopes, the final rinse should only be with distilled water.

Of course, paying close attention to products’ expiration dates is also critical, as STERIS product manager Erin Linville pointed out. "Using an instrument cleaning chemistry within its shelf life can help assure consistent performance in soil removal and instrument protection."

As with any healthcare product, education is essential for ensuring its proper use. Although instructions and MSDSs, orientations and inservices are key components of a training program, sources agree that more can – and should – be done to ensure safe and effective use of detergents and disinfectants.

Lind recommends a multi-layered training approach to promote consistency and encourage ongoing compliance with instructions to drive safe, appropriate, effective product use. She favors signs and labels in storage and point-of-use areas to differentiate among products and suggests drawing measurement marks and simple icons on the products themselves.

Hands-on drills are another effective means of educating staff on the fundamentals of safe use and handling of chemicals in the SPD. Narance is gearing up for his department’s first-ever chemical spill evacuation drill. "I’m going to walk in with the Hazmat chief and simulate a spill to see how staff responds. I wanted to do this because I need to be sure that they would know what to do if it ever does occur. A leak or spill is a very dangerous situation, so I want to make sure they are adequately trained and prepared to handle it correctly."

Metrex EmPower foam spray

Because the manufacturer is the one to establish the instructions for effective use of its chemicals, it only makes sense that SPDs rely on them for their expertise. "It may help for [staff] to have someone, such as a manufacturer rep, help them evaluate their current processes," said Rossana Fernandez, marketing manager II, medical products, Metrex, Orange, CA. "Sometimes it takes an outsider to help bring new ideas and best practice recommendations they have seen work in other facilities."

More than ever, vendors are providing a wide range of educational offerings to better support their customers — not only providing hands-on training and answering specific questions as they arise, but in many cases, also leaving behind valuable educational tools, such as videos, posters and other visuals, that can facilitate ongoing education. Even so, Medisafe’s Bramlett said users should be aware that some manufacturer information may be biased. For that reason, she encourages CS staff to layer manufacturer information with that from other sources. "Independent educational sources, hospital education departments, national CS organizations, such as IAHCSMM & ASHCSP, are excellent sources."

While improved disinfectants and solutions are certainly a benefit to today’s SPDs, that doesn’t mean each new product should reside on a department’s must-have list. On the contrary, Lind said that product standardization is one of the most effective ways of reducing confusion and driving consistency, and curtailing out-of-control costs.