Sterilization quality assurance requires multi-pronged approach

There's no denying it: Many of today's sterile processing departments are operating with fewer staff and resources, being challenged with new technology and instrumentation, and having to turn instrument sets over more rapidly to meet the increasing caseload demands of the operating room.

And while it can be argued flint virtually ever department within the healthcare organization is being forced to do more with less, the fact remains that in the name of quality patient care, some processes simply cannot be rushed--most notably, the proper cleaning and sterilization of instruments. Savvy central service professionals (and the customers they serve) understand that effective management and assessment of sterilization processes requires a thorough, well implemented sterility assurance program.

A well-rounded sterility quality assurance process involves mechanical or electrical controls, chemical and biological indicators, sterilizer maintenance, conscientious record keeping, ongoing staff education, and above all, proper preparation practices to boost the effectiveness of the sterilization process.

"Each of these elements is critical, but they aren't effective solely on their own, They must work in tandem," said Charles O. Hancock, president, Hancock & Associates, Fairport, NY.

These elements are not foolproof, either. As CS consultant Natalie Lind of Sank Rapids, MN, puts it, sterilization is not a magic process that happens behind the closed door of the sterilizer. She also stresses that sterilizers are machines, and therefore susceptible to breakdown mad failure.

"Even the newest sterilizers cannot sterilize items that have been incorrectly prepared for sterilization. That preparation depends entirely on the skills and the attention to detail of each CS technician involved in the sterilization process," she noted.

Barriers to sterilization quality

Despite the critical value of a sound quality assurance program, challenges and misconceptions related to sterility assurance abound, which can undermine its importance, up the odds of sterilization failure, and negatively impact processes and patient care.

Among those challenges are unrealistic demands being placed on sterile processing staff to turn around sets quickly, despite their lack of adequate instrument inventory.

"Often, CS isn't given enough time to clean and sterilize properly," said Gary Melvin, national sales manager, Getinge USA, Rochester, NY. "CS either needs to be given more time or more instruments. Unfortunately, many facilities are not recognizing this need and are continuing to place more pressure on the department."

Perhaps the greatest challenge in achieving sterility assurance is the lack of understanding about what it is really means and how it is accomplished, according to Sandra Lee, senior manager of professional education for STERIS Corp., Mentor, OH.

Another challenge, she said, is finding the time and resources to build a sterility assurance educational program that includes all factors that impact the process. These factors include decontamination; principles of sterilization, including chemical and biological monitoring; preparation of items for sterilization; loading the sterilizer properly; using a properly functioning sterilizer; choosing the appropriate sterilization cycle and parameters; knowing how to handle sterilized goods for sterility maintenance; and having complete knowledge of standards and recommended practices by the Association for the Advancement of Medical Instrumentation that pertain to decontamination and sterilization.

"Yet another challenge in achieving sterility assurance is finding the time for education and training of all individuals involved in sterile processing, to drive home the need for the attention to detail that will achieve sterility assurance. This education must be ongoing and always begin upon initial orientation of a new employee," Lee explained, adding that employee performance must be continually audited via regularly scheduled evaluation of their core competencies.

Understanding quality controls

Sterile processing departments have access to a bevy of products and tools designed to monitor the sterilization process. At the most basic level, CS personnel rely on mechanical and electronic controls to monitor time, temperature and pressure, and then record these readings following each sterilization cycle, per AAMI recommendations.

According to AAMI standard ST46:2002, Steam Sterilization and Sterility Assurance in Health Care Facilities, documentation ensures monitoring of the process as it is occurring, ensures that cycle parameters have been met and establishes accountability. It also helps personnel determine whether recalls are necessary.

In addition to mechanical monitoring, CS departments should also be using chemical and biological indicators to further monitor conditions of sterilization. They should also be aware of these products' unique capabilities and limitations, stressed Heide Ames, associate product manager, sterility assurance, STERIS.

"All personnel involved with sterile processing must fully understand what biological and chemical indicators and integrators are really telling them," she said. "[Such products] are designed to show that [10.sup.6] bacterial spores have been destroyed, whereas sterilization processes kill twice as many spores." STERIS offers a complete line of sterilization quality assurance products, including biological and chemical indicators, packaging, maintenance covers and its latest addition, the AMSCO Sterilization Container System. STERIS also offers comprehensive educational programs and service products to support the sterility assurance process.

Specifically, chemical indicators are designed to respond with a chemical or physical change to one or more of the physical conditions within the sterilizer chamber, and are recommended for use in every load. These indicators assist in the detection of potential sterilization failures that could result from incorrect packaging, incorrect loading of the sterilizer or malfunctions of the sterilizer.

AAMI recognizes five classes of chemical indicators, each of which monitor different conditions within the sterilizer chamber. Class 1 indicators are intended for use with individual packs or containers to show that the unit has been exposed to the sterilization process and distinguish between processes and unprocessed units; Class 2 indicators include Bowie-Dick tests and are used to evaluate the efficacy of air removal in dynamic-air-removal steam sterilizers (not a sterility assurance test); Class 3 indicators are single-parameter tests designed to react to due of the critical parameters of sterilization and indicate exposure to a sterilization cycle at a stated value of the chosen parameter; Class 4, multi-parameter indicators are designed to react to two or more of the critical parameters of sterilization and indicate exposure In a sterilization cycle at stated values of chosen parameters; and Class 5 integrating indicators are designed to react to all critical parameters over a specified range of sterilization cycles. ST46 states that the results of Class 5 integrators may serve as the basis for the release of processed items, excluding implants.

"We encourage the use of multi-parameter indicators because they provide information on all conditions of sterilization," noted Ralph Basile, vice president of marketing, Healthmark Industries Co., St. Clair Shores, MI.

Biological indicators consist of a standardized, viable population of microorganisms known to be resistant to the mode of sterilization being monitored and are considered the most effective means of monitoring sterility assurance. AAMI recommends using biological indicators at least weekly and preferably daily.

"I believe that using a biological daily is just good practice. If there is a recall because a biological comes back positive, you have to go back to the point where the biological was last negative. That's obviously more difficult if you're using them weekly," Hancock said.

Weighing product options

Vendors noted that advancements in chemical indicator technology, have expanded the products' ability to more effectively monitor the sterilization process. According to Basile, Healthmark's integrator product predicts the outcome of a biological and offers a sterner indication of kill than a biological indicator.

The use of biological equivalent products could also help curb costs, noted Charles Hughes, general manager and educator for SPSmedical Supply Corp., Rush, NY. "One of the sterility assurance challenges facing healthcare users today is the overuse of BIs where biological equivalent products could be used [instead] to reduce cost and release loads immediately versus waiting for incubation results," he explained. SPSmedical offers a complete line of color change chemical indicators, as well as biological indicators.

Also adding to the value of newer chemical indicators is advanced "purple to green" ink technology that has been engineered to measure further into the sterilization cycle than a biological spore, and can provide the SPD with confidence that a sterility assurance level of [10.sup.6] has been achieved, noted Debra Schotz, director of marketing, sterility assurance, Cardinal Health, McGaw Park, IL.

"One of the more common challenges with sterilization monitoring is achieving true process control. Biological indicators provide a means to validate spore kill, but they are catastrophic indicators that communicate only a pass or fail," Schotz explained. "If a biological indicator grows out after appropriate incubation, the SPD is faced with a recall situation and must shut down that sterilizer. Certain chemical indicator technology can indicate if the sterilizer is beginning to fall out of control and should be serviced." Cardinal Health offers a complete line of machine, pack and load control products that utilize advanced ink technology.

Getinge USA also offers an instant read, purple to green test pack. It is designed to give the user instant reassurance based on a result from a steam integrator card, as well as a 24-hour biological result. "Whenever you get a pass on this indicator, the biological is always going to be negative," Melvin said.

Don't rush the process

Sources--and standards--are careful to point out that chemical indicators are not designed to replace biological indicators, but rather to work in conjunction with them.

Although certain test packs offer an instant read result, Melvin said users "should still grow out the biological" to ensure that spore kill was achieved. It's also important to note that while the results of Class 5 integrating indicators may serve as the basis for the release of processed items, implants are excluded.

Added Hancock: "There is a lot of confusion regarding the use of indicators. Facilities should be monitoring every load and pack with chemical indicators, but they must also be using a biological. In the United States, the biological indicator is the basis of a quality control system."

In the face of time and resource constraints plaguing CS departments, sources acknowledged there has been a greater demand for faster and easier-to-use indicators. The 3M Attest Rapid Readout biological indicator provides the faster results on the market, with just one hour for steam flash sterilization cycles, three hours for standard steam cycles and four hours for ethylene oxide cycles. And because the Rapid Readout product is a biological indicator, implants can also be released, reminded Kevin Habas, manager for 3M sterilization.

Even with the rapid read capabilities of the BI, users should still be sure to incubate the products for their full 24 or 48 hours, per AAMI recommendations. Also key, according to Hughes, is that users should remember to calibrate the autoreader and/or change out the UV lamp needed for accurate results.

Perhaps most importantly, sources stressed that in spite of the latest process monitoring technology there is no practical means of verifying the sterility of individual items--a sobering reality that again underscores the need for a thorough, multi-faceted approach to sterility assurance.

"When a true quality assurance program is in place, every step from decontamination through sterility maintenance is audited and/or monitored for quality outcomes to effectively support patient care," said Lee. HPN

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