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Copyright © 2013
INSIDE THE CURRENT ISSUE
Aiming lethal weapons against microbial foes
Education, innovation give disinfectants more ammunition
by Julie E. Williamson
Recent media reports of contaminated endoscopes that may have exposed thousands of patients to hepatitis C or HIV have underscored the importance of safe, appropriate and consistent instrument disinfection.
While the two endoscope mishaps – one of which stemmed from endoscopy equipment being rinsed, but not disinfected – occurred at separate Veteran Affairs facilities, it’s important to recognize that instrument processing-related errors can occur at virtually any healthcare facility, although many of these incidents go undetected and never make headlines.
Among the most critical points raised by the recent endoscope debacle: sterile processing professionals and others involved in instrument processing can make grave mistakes, with potentially life-threatening consequences, if they don’t consistently follow industry standards and device and disinfectant manufacturers’ instructions to the letter.
Many factors can contribute to processing shortcuts and decontamination and sterilization errors. One of the greatest challenges, according to Matt Rudolph, senior corporate trainer for Stow, OH-based Spectrum Surgical Instruments Corp., is having less time to properly clean, disinfect and sterilize instruments (and having to do it with less staff).
"The instruments are constantly changing and becoming more complex. With fewer employees, hospitals are being asked to do more with less," he said. "This increases the chances of mistakes in the decontamination area. If the instrument is not clean, it is not sterile."
Insufficient instrumentation levels coupled with increasing case loads that put pressure on staff to rapidly turn around devices is another common SPD complaint that can lead to dangerous processing mistakes. And the challenges don’t end there, either. Lack of ongoing training and consistent direction from SPD managers can contribute to misunderstandings about how to properly clean, disinfect and sterilize devices. What’s more, many sterile processing technicians may find manufacturer instructions vague or confusing. Even industry standards, which some say may not be defined or rigid enough to direct users on best practices, may further increase the risk for error.
"Such standards leave too much room for interpretation or variation in practice, which results in some people doing an excellent job, but many doing a poor job," noted Dixit Gandhi, product manager, central sterile products, Medline Industries Inc., Mundelein, IL.
Consultant Charles Hancock, president of Charles O. Hancock Associates Inc. in Fairport, NY, addressed the shortcomings further.
"In the standards, we talk a lot of cleaning and sterilization, but there’s a big gap in knowledge and understanding regarding disinfection. Even the Spaulding Classification is loosely defined, so it’s no wonder people are struggling."
Set internal standards
While the challenges are very real, the onus of responsibility for ensuring safe, effective instrument processing ultimately falls upon the healthcare institution. The bottom line? In the absence of clearly defined standards, it’s up to each healthcare institution to ensure that challenges impacting staff are addressed as extensively as possible so they don’t interfere with proper protocol and the delivery of clean, effectively processed instruments.
One SPD manager said it’s essential for managers to fight for adequate staffing levels and promote ongoing staff education of all aspects of instrument processing – from before instruments arrive in the decontamination area to their completion of disinfection and sterilization cycles, and beyond.
"Education isn’t something you do once and then just assume that everyone
is going to be doing the right thing all the time," noted David Narance, RN,
BSN, CRCST, sterile reprocessing manager for MedCentral Health System in
Mansfield, OH. "Education should be a never-ending
For starters, technicians should have a solid understanding of which devices will require either high-level disinfection or sterilization, as well as which products are appropriate for use on each type of instrument and piece of equipment. This requires that technicians be knowledgeable about instrumentation to know a device’s purpose, its composition and how it is used – information that will enable them to properly classify a device. Such recommendations may seem like common sense, but sources indicated that some SPDs routinely struggle with even these basic requirements.
"If you don’t know enough about the instruments or the [disinfectants being used], you can really damage instruments. Many of the instruments today have exotic and delicate components, which may or may not be able to withstand certain disinfectants. Some disinfectants aren’t safe to use on certain metals and plastics can be destroyed if you make the mistake of using a product that wasn’t approved for that device. So before you disinfect, you have to ensure compatibility," stressed Narance.
Carefully reading instructions and spec sheets – both for the instruments and the germicidal solutions – is imperative. But even then, confusion can sometimes set in and jeopardize the process’s effectiveness. Concentration and dilution ratios, for example, can trip up even the most diligent technician, especially as facilities switch to more concentrated products.
"In some cases, the calculations are very complicated and manufacturers of these products assume the users have the compounding skills of a pharmacist, which isn’t the case," explained Hancock. "Errors are easily made."
Narance does his best to tackle the issue head-on. "You don’t leave it to [chance]. Any time there’s a new or more concentrated product introduced you have to make sure staff is fully aware of the differences. Again, it boils down to education," he said. "To make sure we’re getting to the correct concentration, we carefully do the math and measure it out beforehand. Guesswork won’t cut it."
The same concern goes for detergents. "If they are not dosed properly or used in their intended manner they cannot be effective," stressed Eric Willman, PhD., senior healthcare program leader for Ecolab Inc., St. Paul, MN.
And don’t forget to turn to the vendors themselves with any questions. "If you bring in a new instrument and are unclear how to process it, or if you have any questions about a detergent, disinfectant or sterilant – or any other product used in the process — go straight to the source," suggested Narance.
Today, vendors are taking a more active role in user education – at times even going beyond practice standards to ensure that clean instruments are being used on patients. As Medline’s Gandhi explained, that involves providing education to help train staff, producing product literature on how to best use products, participating in trials to promote best practices, and continuously evolving products to clean more efficiently.
From pre-decontamination through high-level disinfection or sterilization, SPDs now have access to an ever-growing array of products and technologies to maximize effectiveness, boost efficiencies and eliminate some of the burden (both physical and financial) associated with instrument processing.
Products that prevent soil from drying on devices post-procedure and begin breaking down bioburden even before instruments make their way into decontamination are prevalent today, and a growing number of these products are becoming more eco-friendly.
"Enzymes are very effective at removing blood soil at neutral pH. It can be shown that a neutral enzyme solution has the same cleaning power as a high pH detergent, without the corrosive side effects," Willman explained, adding that because enzymes are derived from biological sources, they have a strong sustainability aspect. Ecolab offers a variety of multi-enzymatic detergents to use in different decontamination processes. The Asepti-Zyme Foaming Detergent removes a wide range of soils and its crystal clear solution allows visibility of instruments during the manual cleaning process.
Ruhof’s ENDOZIME Xtreme Power super-concentrate multi-tiered enzymatic detergent with rust inhibitors delivers fast and thorough soil contamination removal with less detergent usage. Designed for use in all endoscope washers, washer disinfectors, ultrasonic washers and for manual cleaning, Endozime XP features Advanced Proteolytic Action (APA) that greatly increases protease enzyme activity. The detergent penetrates into the hardest- to-reach channels of scopes and cannulated instruments, instantly and actively breaking down gross contaminants upon contact. Endozime XP contains biological additives that speed the process of liquification and solubilization, facilitating enzymatic action and contributing to the product’s overall effectiveness.
Spectrum Surgical has made product enhancements to increase safety for the end user. A new gel formula for its Spectra-Moist product, for example, is biodegradable, phosphate-free, petrochemical-free and VOC-free. The company routinely educates on the importance of keeping devices moist post-procedure. Although products, such as Spectra-Moist are designed for that purpose, Spectrum stresses that even spraying devices with water at the end of the case (and keeping them covered with a wet towel en route to decontam) can go a long way toward assisting in the cleaning process.
The trend toward concentrated solutions is also catching on – a move that is helping reduce waste and per-cycle costs, while also making it easier for staff to handle. Not only do these higher concentrated products perform as well (and, sometimes, better) than standard formulas "the super-concentrate items come in a 2.5-gallon jug and can replace 15-gallon drums," Medline’s Gandhi said. "It is more environmentally-friendly, provides cost saving, is easier to handle and stock, and is more ergonomic for the user." Medline’s super-concentrate line of detergents and lubricants, for example, decrease cost per cycle by up to 25%.
With a nod towards operational efficiency and cost-effectiveness, Metrex MetriCide OPA Plus solution features a slight increase in strength allowing it to deliver up to 32 more reprocessing cycles when compared to the competing ortho-Phthalaldehyde (OPA) based high-level disinfectant brand. The added active ingredient content in MetriCide OPA Plus enhances the product’s use life (within the stated 14-day reuse period). Moreover, MetriCide OPA Plus test strips read 33% faster, increasing back office efficiencies while reducing the threat of healthcare acquired infections.
One Getinge USA product manager also considers new concentrations to be among the most noteworthy disinfectant-related enhancements. "This new chemistry enables users to minimize logistical costs and storage space, and maximize disinfectant efficacy and efficiency," reasoned Christopher Dudley, Getinge Infection Control consumable products sales manager. Getinge’s detergents and disinfectants are also color-coded for ease of identification and application – even for non-English-speaking users. Also, for automated dispensers of these products, Getinge includes tube stickers to ensure that the proper wand is inserted into the correct container.
"All of our safety and MSDS information, including kill claims, are included in our product literature, as well as published on our website," noted Dudley, adding that Getinge customers also receive free training and inservice information on an initial and recurring basis, as necessary, to ensure proper education during initial start-up, as well as during periods of staff turnaround.
Of course, advancements have also been made on the disinfection and sterilization side. Today, SPDs have an ability to sterilize at lower temperatures and with shorter cycle times – both attributes that help turn inventory faster and minimize damage to instruments, which lowers operational and replacement costs, stressed Peter Gordon, vice president of marketing for Germgard Lighting LLC. Gordon explained that Germgard’s room temperature process and operational mode is different from conventional low temperature gas or steam sterilizers.
"We overcome the limits of fixed capacity," he said, noting that the Germgard approach is scaleable and allows parallel processing. Kits, of various sizes, of instruments can be prepared and filled with the proprietary gas sterilant and then set aside while the gas does its job. Kits of instruments can be filled in a minute or so, removed and set aside, with their loads then processed in parallel, thereby allowing large throughput from a small tabletop system, Gordon reasoned. Also, the overall system is "environmentally-friendly, using less electricity, requiring no water and no wasteful sterile wrap." And when users open the kit to remove the instruments, it only contains air, added Gordon.
Advanced Sterilization Products’ STERRAD 100NX System, which provides low-temperature hydrogen peroxide gas plasma sterilization, can safely reprocess heat-sensitive devices. "Key to the technology is the plasma phase, which is an active biological process that efficiently eliminates hydrogen peroxide residuals on instruments by breaking them down into water vapor and oxygen," said Charles Roberts, MS, director of ASP’s research and development for biocides. "As a result, aeration and external venting are not required."
Major advancements have been made regarding endoscope disinfection, with user safety and efficacy serving as the driving factors in product development. ASP’s EVOTECH Endoscope Cleaner and Reprocessor system was designed to eliminate labor-intensive manual endoscope cleaning (when selecting a cycle that includes a wash stage) and the variability inherent to it. [Note: The EVOTECH system does not eliminate bedside precleaning in procedure rooms, and no manual cleaning is required when selecting a cycle that has a wash stage.]
"The system uses a separate pump for each endoscope channel, which allows for lumen blockage and leak testing," noted ASP’s director of clinical education Barbara Trattler, RN, MPA, CNOR, CNA. "Also, the system reduces worker exposure to chemicals and delivers CIDEX OPA Concentrate and CIDEZYME GI for each cycle automatically, ensuring that fresh solution is used every time for every scope."
Focus on the future
So what can SPDs expect from the disinfectant and sterilization market moving forward?
According to one ASP expert, the biggest improvements will likely come on the process side. "Sterilants and disinfects on the market today are already very effective," said ASP R&D manager Chris French, PhD. "Advances in sterilization and disinfection will, therefore, most likely be in the area of process improvements. Reprocessing equipment will become easier to use and more automated to ensure consistency of reprocessing and to minimize operator training requirements."
French further forecasted that technology will likely be embedded to ensure flawless tracking of medical instruments, and data may be logged and integrated with medical user data management software. What’s more, reprocessing chemistries will be entirely contained to minimize or eliminate exposure, he said, and advances in microbial analysis will allow for the automatic identification of pathogens of concern from trace residues on devices.
Moving forward, Getinge’s Dudley predicts manufacturers will be developing even more adaptive disinfectant solutions that will be more adept at providing effective performance quality – even in the face of more resistant organisms.
"Our biggest challenge is rapidly mutating organisms and the recertification process to ensure comprehensive kill claims," he said. "I believe that the creation and implementation of an ideal sterility assurance program with extremely conservative assurance products, using the most innovative technology, is the key to minimizing the [overuse] of antibiotics during hospital stays, especially now that healthcare facilities are being held responsible for nosocomial infections." Dudley sees increased testing, claim certification and proper use, along with procedural compliance, as an even greater necessity.
In the future, SPDs may also see the development of more productive partnerships between key constituents – from instrument and reprocessing product and equipment manufacturers to SPD staffers and infection control professionals – to promote seamless integration of technologies.
"Our mission is to develop integrated solutions in partnership with our customers and use innovative technologies that dramatically reduce the human and financial costs of nosocomial infection," said ASP’s Roberts. "Only then may seamless integration of device and reprocessing technologies occur to the benefit of all parties, and as a result, raise the bar for the standard of care and eliminate the tremendous impact of errors and accidental misuse of sterilants and disinfectants."